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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00162266




Registration number
NCT00162266
Ethics application status
Date submitted
9/09/2005
Date registered
13/09/2005
Date last updated
1/06/2012

Titles & IDs
Public title
Abatacept With Methotrexate- Phase IIB
Scientific title
A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
Secondary ID [1] 0 0
IM101-100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept (BMS-188667)
Treatment: Drugs - Abatacept (BMS-188667)
Treatment: Drugs - Abatacept (BMS-188667)
Treatment: Drugs - Placebo

Experimental: Abatacept (10 mg/Kg) - Open Label -

Experimental: Abatacept (2 mg/kg) - Double blind -

Experimental: Abatacept (10 mg/kg) - Double blind -

Experimental: Placebo - Double blind -


Treatment: Drugs: Abatacept (BMS-188667)
IV, 10 mg/Kg, monthly, for the duration of the trial

Treatment: Drugs: Abatacept (BMS-188667)
Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months

Treatment: Drugs: Abatacept (BMS-188667)
Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months

Treatment: Drugs: Placebo
Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period
Assessment method [1] 0 0
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Timepoint [1] 0 0
Day 180
Primary outcome [2] 0 0
Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period
Assessment method [2] 0 0
The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics.
Timepoint [2] 0 0
Day 360 to Day 3,060
Primary outcome [3] 0 0
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period
Assessment method [3] 0 0
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug.
Timepoint [3] 0 0
Day 360 to Day 3060
Primary outcome [4] 0 0
Number of Participants With AEs of Special Interest in OL Period
Assessment method [4] 0 0
AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest were those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion.
Timepoint [4] 0 0
Day 360 to Day 3060
Primary outcome [5] 0 0
Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period
Assessment method [5] 0 0
Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6.
Timepoint [5] 0 0
Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800
Primary outcome [6] 0 0
Mean Change From Baseline (BL) in IgA Over Time in OL Period
Assessment method [6] 0 0
Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5.
Timepoint [6] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Primary outcome [7] 0 0
Baseline Immunoglobulin G (IgG) Over Time in OL Period
Assessment method [7] 0 0
Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8.
Timepoint [7] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800
Primary outcome [8] 0 0
Mean Change From Baseline (BL) in IgG Over Time in OL Period
Assessment method [8] 0 0
Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7.
Timepoint [8] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Primary outcome [9] 0 0
Baseline Immunoglobulin M (IgM) Over Time in OL Period
Assessment method [9] 0 0
Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10.
Timepoint [9] 0 0
Baseline (Day 0) and Days 360, 720,1080,1440, and 1800
Primary outcome [10] 0 0
Mean Change From Baseline (BL) in IgM in OL Period
Assessment method [10] 0 0
Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9.
Timepoint [10] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Primary outcome [11] 0 0
Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period
Assessment method [11] 0 0
Timepoint [11] 0 0
Day 360 to Day 3060
Primary outcome [12] 0 0
Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period
Assessment method [12] 0 0
Timepoint [12] 0 0
Day 360 to Day 3060
Primary outcome [13] 0 0
Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period
Assessment method [13] 0 0
Timepoint [13] 0 0
Day 360 to Day 3060
Primary outcome [14] 0 0
Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period
Assessment method [14] 0 0
Timepoint [14] 0 0
Day 360 to Day 3060
Secondary outcome [1] 0 0
Number of ACR 20 Responders in DB Period
Assessment method [1] 0 0
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Timepoint [1] 0 0
Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360
Secondary outcome [2] 0 0
Number of ACR 50 Responders in DB Period
Assessment method [2] 0 0
ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Timepoint [2] 0 0
Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
Secondary outcome [3] 0 0
Number of ACR 70 Responders in DB Period
Assessment method [3] 0 0
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
Timepoint [3] 0 0
Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
Secondary outcome [4] 0 0
ACR Numeric Values (ACR-N)
Assessment method [4] 0 0
The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.
Timepoint [4] 0 0
Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
Secondary outcome [5] 0 0
ACR-N Area Under The Curve (AUC) on Day 180 and Day 360
Assessment method [5] 0 0
The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.
Timepoint [5] 0 0
Baseline and Day 180; Baseline and Day 360
Secondary outcome [6] 0 0
Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180
Assessment method [6] 0 0
Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\])
Timepoint [6] 0 0
Baseline, Day 180
Secondary outcome [7] 0 0
Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360
Assessment method [7] 0 0
Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\])
Timepoint [7] 0 0
Baseline, Day 360
Secondary outcome [8] 0 0
Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360
Assessment method [8] 0 0
SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.
Timepoint [8] 0 0
Baseline, Day 180, Day 360
Secondary outcome [9] 0 0
Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360
Assessment method [9] 0 0
A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.
Timepoint [9] 0 0
Baseline, Day 180, Day 360
Secondary outcome [10] 0 0
Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360
Assessment method [10] 0 0
Timepoint [10] 0 0
Day 180, Day 360
Secondary outcome [11] 0 0
Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period
Assessment method [11] 0 0
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.
Timepoint [11] 0 0
From the start of study through the end of the double-blind period (at 12 months)
Secondary outcome [12] 0 0
Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy
Assessment method [12] 0 0
Timepoint [12] 0 0
From the start of study up to 60 days post the end of the 12-month double-blind period
Secondary outcome [13] 0 0
Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy
Assessment method [13] 0 0
Timepoint [13] 0 0
From the start of study up to 60 days post the end of the 12-month double-blind period
Secondary outcome [14] 0 0
Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods
Assessment method [14] 0 0
Timepoint [14] 0 0
Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period)
Secondary outcome [15] 0 0
Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region
Assessment method [15] 0 0
Timepoint [15] 0 0
Baseline, Days 30, 90, 180, 270, 360
Secondary outcome [16] 0 0
Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region
Assessment method [16] 0 0
Timepoint [16] 0 0
Baseline, Days 30, 90, 180, 270, 360
Secondary outcome [17] 0 0
Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)
Assessment method [17] 0 0
Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
Timepoint [17] 0 0
Baseline, Days 30, 90, 180, 270, 360
Secondary outcome [18] 0 0
Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)
Assessment method [18] 0 0
Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
Timepoint [18] 0 0
Baseline, Days 30, 90, 180, 270, 360
Secondary outcome [19] 0 0
Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360
Assessment method [19] 0 0
Timepoint [19] 0 0
Baseline, Day 180, Day 360
Secondary outcome [20] 0 0
Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360
Assessment method [20] 0 0
Timepoint [20] 0 0
Baseline, Day 180, Day 360
Secondary outcome [21] 0 0
Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360
Assessment method [21] 0 0
Timepoint [21] 0 0
Baseline, Day 180, Day 360
Secondary outcome [22] 0 0
Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360
Assessment method [22] 0 0
Timepoint [22] 0 0
Baseline, Day 180, Day 360
Secondary outcome [23] 0 0
Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360
Assessment method [23] 0 0
Timepoint [23] 0 0
Baseline, Day 180, Day 360
Secondary outcome [24] 0 0
Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360
Assessment method [24] 0 0
Timepoint [24] 0 0
Baseline, Day 180, Day 360
Secondary outcome [25] 0 0
Number of ACR 20 Responders in OL Period
Assessment method [25] 0 0
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Timepoint [25] 0 0
Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Secondary outcome [26] 0 0
Number of ACR 50 Responders in the OL Period
Assessment method [26] 0 0
ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Timepoint [26] 0 0
Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Secondary outcome [27] 0 0
Number of ACR 70 Responders in the OL Period
Assessment method [27] 0 0
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
Timepoint [27] 0 0
Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Secondary outcome [28] 0 0
Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period
Assessment method [28] 0 0
The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.
Timepoint [28] 0 0
Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [29] 0 0
Baseline Level of Serum Rheumatoid Factor Over Time in OL Period
Assessment method [29] 0 0
Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
Timepoint [29] 0 0
Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [30] 0 0
Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period
Assessment method [30] 0 0
Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.
Timepoint [30] 0 0
Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [31] 0 0
Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period
Assessment method [31] 0 0
Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
Timepoint [31] 0 0
Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [32] 0 0
Mean Change From Baseline in sIL2-r Over Time in OL Period
Assessment method [32] 0 0
Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
Timepoint [32] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
Secondary outcome [33] 0 0
Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period
Assessment method [33] 0 0
Serum evaluations were carried out to evaluate participant serum CRP concentrations at baseline. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Timepoint [33] 0 0
Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060
Secondary outcome [34] 0 0
Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period
Assessment method [34] 0 0
Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
Timepoint [34] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060
Secondary outcome [35] 0 0
Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period
Assessment method [35] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.
Timepoint [35] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Secondary outcome [36] 0 0
Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period
Assessment method [36] 0 0
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.
Timepoint [36] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Secondary outcome [37] 0 0
Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period
Assessment method [37] 0 0
SF-36=PCS, MCS, \& 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, \& mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values \& post-baseline (BL) values are presented for each post-BL visit \& represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.
Timepoint [37] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Secondary outcome [38] 0 0
Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period
Assessment method [38] 0 0
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.
Timepoint [38] 0 0
Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Secondary outcome [39] 0 0
Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period
Assessment method [39] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.
Timepoint [39] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [40] 0 0
Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period
Assessment method [40] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.
Timepoint [40] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [41] 0 0
Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period
Assessment method [41] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.
Timepoint [41] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [42] 0 0
Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period
Assessment method [42] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.
Timepoint [42] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [43] 0 0
Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period
Assessment method [43] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.
Timepoint [43] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [44] 0 0
Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period
Assessment method [44] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.
Timepoint [44] 0 0
BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060
Secondary outcome [45] 0 0
Mean BL General Health Domain of the SF-36 Over Time in OL Period
Assessment method [45] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.
Timepoint [45] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [46] 0 0
Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period
Assessment method [46] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.
Timepoint [46] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [47] 0 0
Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period
Assessment method [47] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.
Timepoint [47] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [48] 0 0
Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period
Assessment method [48] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.
Timepoint [48] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [49] 0 0
Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period
Assessment method [49] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.
Timepoint [49] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [50] 0 0
Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period
Assessment method [50] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.
Timepoint [50] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [51] 0 0
Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period
Assessment method [51] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.
Timepoint [51] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [52] 0 0
Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period
Assessment method [52] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.
Timepoint [52] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [53] 0 0
Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period
Assessment method [53] 0 0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.
Timepoint [53] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Secondary outcome [54] 0 0
Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period
Assessment method [54] 0 0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.
Timepoint [54] 0 0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060

Eligibility
Key inclusion criteria
Double blind study phase:

1. Males or females (not nursing and not pregnant), at least 18 years of age. Women of child bearing potential (WOCBP) are eligible if they are practicing effective contraceptive measures
2. Subjects must meet the criteria of the American Rheumatism Association (1987) for the diagnosis of rheumatoid arthritis and the American College of Rheumatology (1991) functional classes I, II, or III
3. Subjects have been taking Methotrexate (10-30 mg weekly) for at least 6 months, and at a stable dose for 28 days prior to treatment
4. Washout/drug stabilization requirements (except Methotrexate) [Informed consent must be signed before making any changes in RA therapy if those changes are solely for the purpose of this study].

* Leflunomide or Infliximab have already been discontinued at least 60 days prior to enrollment (prior to signing of informed consent) and a total of 90 days prior to treatment. All other Disease Modifying Anti-Rheumatic Drugs (DMARDs) (except Methotrexate) have been withdrawn at least 28 days prior to treatment
* Oral corticosteroid treatment has been reduced to the equivalent of 10 mg or less prednisone daily and stabilized for at least 28 days prior to enrollment
5. Eligibility of subjects for the study is based on their disease activity and anti-rheumatic treatment at the initial visit:

* Methotrexate monotherapy: Subject is receiving only Methotrexate, steroids, Non-steroidal anti-inflammatory drugs (NSAIDs) and will not require washout
* Combination therapy: Subject is receiving Methotrexate in combination with another DMARD(s) and will require washout

At entry, Methotrexate monotherapy must have a disease activity:
* 10 or more swollen joints (66 joint count)
* 12 or more tender joints (68 joint count)
* C reactive protein (CRP) =.1 mg/dL (10 mg/L) at "Screening" visit

At entry, combination therapy must have a disease activity (if subject does not satisfy the above):
* 6 or more swollen joints (66 joint count)
* 8 or more tender joints (68 joint count)
* No restriction on C-reactive protein (CRP)

In addition

All subjects who were on combination therapy at entry must undergo a 28 day washout period of DMARDs other than Methotrexate. After the washout/drug stabilization and prior to randomization such subjects must have:
* 10 or more swollen joints (66 joint count)
* 12 or more tender joints (68 joint count)
* C reactive protein (CRP) = 1 mg/dL (10 mg/L)
6. Subject is willing to participate in the study and willing to sign the informed consent

Open label study phase:

* Participants that have completed the initial short term portion (double blind) of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Double blind study phase:

1. Subjects who have at any time received treatment with BMS-188667 (Abatacept)
2. Subjects who within 30 days of the Day 1 visit have received treatment with any investigational drug
3. Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
4. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease. Concomitant medical conditions that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study
5. Mammogram requiring further investigation or biopsies leading to the diagnosis of a clinically significant abnormality. Complete evaluation of lesion is required before initiation of dosing
6. Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection)
7. Subjects who have a history of clinically significant drug or alcohol abuse, or admit to consumption of more than 1 alcoholic drink per day
8. Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection, or hepatitis B or C infection
9. Subjects with any serious or chronic infections such as pneumonia, pyelo-nephritis, renal infection, chest infection with bronchiectasis, or sinusitis in the previous 3 months
10. Subjects with active tuberculosis requiring treatment within the previous 3 years
11. Subjects with any opportunistic infections such as herpes zoster or cytomegalovirus (CMV) within the previous 2 months
12. Subjects with severe asthma defined as > 3 emergency room admissions in the last year or > 3 treatments with oral steroids for asthma in the last year
13. A history of either angioedema or anaphylaxis that was associated with a reaction to a drug
14. Subjects with the following laboratory values:

* Hemoglobin < 8.5 g/dL
* White blood cells < 3000/mm3
* Platelets < 100,000/mm3
* Serum creatinine > 2 times upper limit of normal
* Serum Alanine aminotransferase (ALAT) or Aspartate aminotransferase (ASAT) > 2 times upper limit of normal
* Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study

Open label study phase:

* Participants must continue to meet inclusion/exclusion criteria as in the short term (double blind) phase of the protocol except subjects who have receiving other than Abatacept

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
524
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Adelaide
Recruitment hospital [2] 0 0
Local Institution - Malvern
Recruitment hospital [3] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Malvern
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
Argentina
State/province [17] 0 0
Burenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aries
Country [19] 0 0
Belgium
State/province [19] 0 0
Antwerpen
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Belgium
State/province [23] 0 0
Mons
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
St. John
Country [28] 0 0
France
State/province [28] 0 0
Cedex
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Freiburg
Country [32] 0 0
Germany
State/province [32] 0 0
Jena
Country [33] 0 0
Ireland
State/province [33] 0 0
Cork
Country [34] 0 0
Netherlands
State/province [34] 0 0
Nijmegen
Country [35] 0 0
South Africa
State/province [35] 0 0
Gauteng
Country [36] 0 0
South Africa
State/province [36] 0 0
Western Cape
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Cambridgeshire
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Greater Manchester
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Kent
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00162266