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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00853385




Registration number
NCT00853385
Ethics application status
Date submitted
27/02/2009
Date registered
2/03/2009
Date last updated
18/01/2013

Titles & IDs
Public title
A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Scientific title
Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Secondary ID [1] 0 0
A3921064
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 - CP 690,550
Treatment: Drugs - CP-690,550
Other interventions - Placebo
Other interventions - Placebo
Treatment: Other - Biologic TNFi

Experimental: 5mg -

Experimental: 10 mg -

Placebo comparator: Placebo Sequence 1 -

Placebo comparator: Placebo Sequence 2 -

Active comparator: adalimumab -


Treatment: Drugs: CP 690,550
tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months

Treatment: Drugs: CP-690,550
tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months

Other interventions: Placebo
placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Other interventions: Placebo
tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Treatment: Other: Biologic TNFi
placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Assessment method [1] 0 0
ACR20 response: greater than or equal to (\>=) 20% improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Timepoint [1] 0 0
Month 6
Primary outcome [2] 0 0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Assessment method [2] 0 0
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Timepoint [2] 0 0
Baseline, Month 3
Primary outcome [3] 0 0
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Assessment method [3] 0 0
DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (\<=) 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and \< 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Timepoint [3] 0 0
Month 6
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
Assessment method [1] 0 0
ACR20 response: \>=20% improvement in TJC; \>= 20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Timepoint [1] 0 0
Month 1, 3
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
Assessment method [2] 0 0
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Timepoint [2] 0 0
Month 9, 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
Assessment method [3] 0 0
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Timepoint [3] 0 0
Month 1, 3, 6
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
Assessment method [4] 0 0
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Timepoint [4] 0 0
Month 9, 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
Assessment method [5] 0 0
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Timepoint [5] 0 0
Month 1, 3, 6
Secondary outcome [6] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
Assessment method [6] 0 0
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Timepoint [6] 0 0
Month 9, 12
Secondary outcome [7] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Assessment method [7] 0 0
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Timepoint [7] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [8] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
Assessment method [8] 0 0
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Timepoint [8] 0 0
Month 9, 12
Secondary outcome [9] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Assessment method [9] 0 0
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Timepoint [9] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [10] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
Assessment method [10] 0 0
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Timepoint [10] 0 0
Month 9, 12
Secondary outcome [11] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Assessment method [11] 0 0
DAS28-4 \[CRP\] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Timepoint [11] 0 0
Baseline, Month 1, 3, 6, 9, 12
Secondary outcome [12] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Assessment method [12] 0 0
DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Timepoint [12] 0 0
Baseline, Month 1, 3, 6, 9, 12
Secondary outcome [13] 0 0
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
Assessment method [13] 0 0
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Timepoint [13] 0 0
Month 1, 3, 6
Secondary outcome [14] 0 0
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
Assessment method [14] 0 0
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Timepoint [14] 0 0
Month 9, 12
Secondary outcome [15] 0 0
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Assessment method [15] 0 0
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Timepoint [15] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [16] 0 0
Patient Assessment of Arthritis Pain at Month 9 and 12
Assessment method [16] 0 0
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Timepoint [16] 0 0
Month 9, 12
Secondary outcome [17] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Assessment method [17] 0 0
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Timepoint [17] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [18] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Assessment method [18] 0 0
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Timepoint [18] 0 0
Month 9, 12
Secondary outcome [19] 0 0
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Assessment method [19] 0 0
Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Timepoint [19] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [20] 0 0
Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
Assessment method [20] 0 0
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Timepoint [20] 0 0
Month 9, 12
Secondary outcome [21] 0 0
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Assessment method [21] 0 0
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Timepoint [21] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [22] 0 0
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Assessment method [22] 0 0
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Timepoint [22] 0 0
Month 9, 12
Secondary outcome [23] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Assessment method [23] 0 0
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Timepoint [23] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [24] 0 0
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
Assessment method [24] 0 0
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Timepoint [24] 0 0
Month 12
Secondary outcome [25] 0 0
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Assessment method [25] 0 0
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Timepoint [25] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [26] 0 0
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Assessment method [26] 0 0
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Timepoint [26] 0 0
Month 12
Secondary outcome [27] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Assessment method [27] 0 0
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Timepoint [27] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [28] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Assessment method [28] 0 0
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Timepoint [28] 0 0
Month 12
Secondary outcome [29] 0 0
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
Assessment method [29] 0 0
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Timepoint [29] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [30] 0 0
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
Assessment method [30] 0 0
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Timepoint [30] 0 0
Month 12
Secondary outcome [31] 0 0
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Assessment method [31] 0 0
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Timepoint [31] 0 0
Month 3, 6
Secondary outcome [32] 0 0
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
Assessment method [32] 0 0
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Timepoint [32] 0 0
Baseline, Month 12
Secondary outcome [33] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Assessment method [33] 0 0
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Timepoint [33] 0 0
Baseline, Month 3, 6
Secondary outcome [34] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Assessment method [34] 0 0
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Timepoint [34] 0 0
Month 12
Secondary outcome [35] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Assessment method [35] 0 0
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Timepoint [35] 0 0
Baseline, Month 3, 6
Secondary outcome [36] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Assessment method [36] 0 0
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Timepoint [36] 0 0
Month 12
Secondary outcome [37] 0 0
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Assessment method [37] 0 0
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Timepoint [37] 0 0
Baseline, Month 3, 6
Secondary outcome [38] 0 0
Number of Days as Assessed Using RA-HCRU at Month 12
Assessment method [38] 0 0
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Timepoint [38] 0 0
Month 12
Secondary outcome [39] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Assessment method [39] 0 0
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Timepoint [39] 0 0
Baseline, Month 3, 6
Secondary outcome [40] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Assessment method [40] 0 0
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Timepoint [40] 0 0
Month 12
Secondary outcome [41] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Assessment method [41] 0 0
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Timepoint [41] 0 0
Baseline, Month 3, 6
Secondary outcome [42] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Assessment method [42] 0 0
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Timepoint [42] 0 0
Month 12

Eligibility
Key inclusion criteria
* The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: =6 joints tender or painful on motion; and =6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L
* History of any other autoimmune rheumatic disease other than Sjogren's syndrome
* No malignancy or history of malignancy.
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
* Patients who have previously received adalimumab therapy for any reason.
* Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
* Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

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 3
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
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
717
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Cairns
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Malvern East
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
West Virginia
Country [20] 0 0
Bosnia and Herzegovina
State/province [20] 0 0
Sarajevo
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Pleven
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Plovdiv
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sevlievo
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sofia
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Nova Scotia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Canada
State/province [29] 0 0
Saskatchewan
Country [30] 0 0
Chile
State/province [30] 0 0
RM
Country [31] 0 0
Chile
State/province [31] 0 0
Santiago, RM
Country [32] 0 0
Chile
State/province [32] 0 0
VI Region
Country [33] 0 0
Costa Rica
State/province [33] 0 0
Cartago
Country [34] 0 0
Costa Rica
State/province [34] 0 0
San Jose
Country [35] 0 0
Croatia
State/province [35] 0 0
Osijek
Country [36] 0 0
Croatia
State/province [36] 0 0
Split
Country [37] 0 0
Croatia
State/province [37] 0 0
Zagreb
Country [38] 0 0
Czech Republic
State/province [38] 0 0
Brno - Zidenice
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Brno
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Hlucin
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Pardubice
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Praha 11 - Chodov
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Praha 11
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Praha 2
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Praha 4
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Zlin
Country [47] 0 0
Denmark
State/province [47] 0 0
Frederiksberg
Country [48] 0 0
Denmark
State/province [48] 0 0
Randers NOE
Country [49] 0 0
Dominican Republic
State/province [49] 0 0
Santo Domingo
Country [50] 0 0
Finland
State/province [50] 0 0
Hyvinkaa
Country [51] 0 0
Germany
State/province [51] 0 0
Aachen
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Frankfurt am Main
Country [54] 0 0
Germany
State/province [54] 0 0
Halle
Country [55] 0 0
Germany
State/province [55] 0 0
Herne
Country [56] 0 0
Germany
State/province [56] 0 0
Ratingen
Country [57] 0 0
Germany
State/province [57] 0 0
Wuerzburg
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Daegu
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Gwangju
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Mexico
State/province [61] 0 0
DF
Country [62] 0 0
Mexico
State/province [62] 0 0
Jalisco
Country [63] 0 0
Mexico
State/province [63] 0 0
Michoacan
Country [64] 0 0
Mexico
State/province [64] 0 0
SLP
Country [65] 0 0
Philippines
State/province [65] 0 0
Batangas
Country [66] 0 0
Philippines
State/province [66] 0 0
Pampanga
Country [67] 0 0
Philippines
State/province [67] 0 0
Cebu City
Country [68] 0 0
Poland
State/province [68] 0 0
Bialystok
Country [69] 0 0
Poland
State/province [69] 0 0
Cieszyn
Country [70] 0 0
Poland
State/province [70] 0 0
Koscian
Country [71] 0 0
Poland
State/province [71] 0 0
Krakow
Country [72] 0 0
Poland
State/province [72] 0 0
Sopot
Country [73] 0 0
Poland
State/province [73] 0 0
Torun
Country [74] 0 0
Poland
State/province [74] 0 0
Warszawa
Country [75] 0 0
Slovakia
State/province [75] 0 0
Bratislava
Country [76] 0 0
Slovakia
State/province [76] 0 0
Dunajska Streda
Country [77] 0 0
Slovakia
State/province [77] 0 0
Kosice
Country [78] 0 0
Slovakia
State/province [78] 0 0
Nove Zamky
Country [79] 0 0
Slovakia
State/province [79] 0 0
Povazska Dystrica
Country [80] 0 0
Slovakia
State/province [80] 0 0
Zilina
Country [81] 0 0
Spain
State/province [81] 0 0
A Coruña
Country [82] 0 0
Spain
State/province [82] 0 0
Pontevedra
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Sevilla
Country [85] 0 0
Spain
State/province [85] 0 0
Valencia
Country [86] 0 0
Thailand
State/province [86] 0 0
Bangkok
Country [87] 0 0
Thailand
State/province [87] 0 0
Chiang Mai
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Merseyside
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Staffs
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Dudley, West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT00853385