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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00565409




Registration number
NCT00565409
Ethics application status
Date submitted
28/11/2007
Date registered
30/11/2007
Date last updated
10/08/2015

Titles & IDs
Public title
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Scientific title
A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
Secondary ID [1] 0 0
B1801003
Secondary ID [2] 0 0
0881A1-4423
Universal Trial Number (UTN)
Trial acronym
PRESERVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 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 - Etanercept
Treatment: Drugs - Methotrexate
Treatment: Drugs - Etanercept
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo
Treatment: Drugs - Methotrexate

Active comparator: 1 -

Active comparator: 2 -

Placebo comparator: 3 -


Treatment: Drugs: Etanercept
Subcutaneous (SC), 50 mg, once weekly for 88 weeks

Treatment: Drugs: Methotrexate
Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Treatment: Drugs: Etanercept
Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.

Treatment: Drugs: Methotrexate
Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Treatment: Drugs: Placebo
Subcutaneous (SC), once weekly from week 36 to week 88.

Treatment: Drugs: Methotrexate
Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (=) 3.2 at Week 88
Assessment method [1] 0 0
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than \[\<\]20 percent \[%\] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 = 3.2 units equals (=) low disease activity.
Timepoint [1] 0 0
Week 88
Secondary outcome [1] 0 0
Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36
Assessment method [1] 0 0
DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 = 3.2 units = low disease activity, DAS28 \< 2.6 units = remission.
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 20, 28, 36
Secondary outcome [2] 0 0
Percentage of Participants Achieving DAS28 Low Disease Activity or Remission
Assessment method [2] 0 0
DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 = 3.2 units = low disease activity, DAS28 \< 2.6 units = remission.
Timepoint [2] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [3] 0 0
Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [3] 0 0
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.
Timepoint [3] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [4] 0 0
Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88
Assessment method [4] 0 0
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation.
Timepoint [4] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [5] 0 0
Time to Loss of Low Disease Activity DAS28 and a Change of = 0.6 Units in the DAS28
Assessment method [5] 0 0
DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. Low disease activity = DAS28 = 3.2 units. DAS28 \> 3.2 to 5.1 units = moderate to high disease activity.
Timepoint [5] 0 0
Week 36 up to Week 88
Secondary outcome [6] 0 0
Time to Loss of Low Disease Activity DAS28
Assessment method [6] 0 0
DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 = 3.2 units = low disease activity, DAS28 greater than (\>)3.2 to 5.1 units = moderate to high disease activity.
Timepoint [6] 0 0
Week 36 up to Week 88
Secondary outcome [7] 0 0
Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88
Assessment method [7] 0 0
DAS28 calculated from the number of SJC and PJC using the 28 joints, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 \< 3.2 units = low disease activity. Cumulative proportion calculated as time-averaged Area Under the Curve (AUC) (AUC divided by number of weeks at that time point), with AUC calculated from Week 36 and Week 88.
Timepoint [7] 0 0
Week 36 up to Week 88
Secondary outcome [8] 0 0
Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [8] 0 0
American College of Rheumatology (ACR), swollen joint count were an assessment of 28 joints. Joints are classified as either swollen or not swollen. If \< 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - baseline observation.
Timepoint [8] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [9] 0 0
Prorated Swollen Joint Count at Week 36
Assessment method [9] 0 0
ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If \< 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by number of non-missing swollen joints). Total possible score of swollen joints ranged from 0-28.
Timepoint [9] 0 0
Week 36
Secondary outcome [10] 0 0
Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88
Assessment method [10] 0 0
ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If \< 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.
Timepoint [10] 0 0
Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [11] 0 0
Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [11] 0 0
A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Baseline observation.
Timepoint [11] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [12] 0 0
Painful Joint Count at Week 36
Assessment method [12] 0 0
A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28.
Timepoint [12] 0 0
Week 36
Secondary outcome [13] 0 0
Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88
Assessment method [13] 0 0
Total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.
Timepoint [13] 0 0
Weeks 36 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [14] 0 0
Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [14] 0 0
PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation.
Timepoint [14] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [15] 0 0
PGA Score at Week 36
Assessment method [15] 0 0
PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.
Timepoint [15] 0 0
Week 36
Secondary outcome [16] 0 0
Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88
Assessment method [16] 0 0
PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation.
Timepoint [16] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [17] 0 0
Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [17] 0 0
Participants asked to rate their overall arthritis activity by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Baseline observation.
Timepoint [17] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [18] 0 0
PtGA of Arthritis Pain at Week 36
Assessment method [18] 0 0
PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity).
Timepoint [18] 0 0
Week 36
Secondary outcome [19] 0 0
Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88
Assessment method [19] 0 0
PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Week 36 observation.
Timepoint [19] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80, 88
Secondary outcome [20] 0 0
Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [20] 0 0
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour times \[\*\] 60 min) was recorded. Change = Week X observation - Baseline observation.
Timepoint [20] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [21] 0 0
Duration of Morning Stiffness at Week 36
Assessment method [21] 0 0
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour \* 60 min) was recorded.
Timepoint [21] 0 0
Week 36
Secondary outcome [22] 0 0
Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88
Assessment method [22] 0 0
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour \* 60 min) was recorded. Change = Week X observation - Week 36 observation.
Timepoint [22] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80, 88
Secondary outcome [23] 0 0
Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [23] 0 0
General Health VAS is a 100 millimeter (mm) line marked by the participant. Participants were asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Baseline observation.
Timepoint [23] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [24] 0 0
General Health at Week 36
Assessment method [24] 0 0
General Health VAS is a 100 mm line marked by the participant. Participants are asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad.
Timepoint [24] 0 0
Week 36
Secondary outcome [25] 0 0
Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88
Assessment method [25] 0 0
General Health VAS is a 100 mm line marked by the participant. Participants were asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Week 36 observation.
Timepoint [25] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80, 88
Secondary outcome [26] 0 0
Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [26] 0 0
100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Baseline observation.
Timepoint [26] 0 0
Baseline, Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [27] 0 0
Pain at Week 36
Assessment method [27] 0 0
100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = pain as bad as it could be. Change = Week x observation minus (-) Baseline observation.
Timepoint [27] 0 0
Week 36
Secondary outcome [28] 0 0
Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88
Assessment method [28] 0 0
100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation.
Timepoint [28] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [29] 0 0
Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36
Assessment method [29] 0 0
PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).
Timepoint [29] 0 0
Baseline, Week 36
Secondary outcome [30] 0 0
Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88
Assessment method [30] 0 0
PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).
Timepoint [30] 0 0
Weeks 36, 64 and 88
Secondary outcome [31] 0 0
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [31] 0 0
EULAR Response Criteria: Good response was defined as \>1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of \<=3.2 units. Non responders were participants with improvement of \<0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of \> 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.
Timepoint [31] 0 0
Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [32] 0 0
Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88
Assessment method [32] 0 0
EULAR Response Criteria: Good response was defined as \>1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of \<=3.2 units. Non responders were participants with improvement of \<0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of \> 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.
Timepoint [32] 0 0
Week 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [33] 0 0
Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [33] 0 0
ACR20 response, = 20 percent (%) improvement in tender joint count; = 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 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 acute phase reactant (ESR).
Timepoint [33] 0 0
Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [34] 0 0
Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Assessment method [34] 0 0
ACR20 response: = 20% improvement in tender joint count; =20% improvement in swollen joint count; and = at least 20% improvement in 3 of the following 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 acute phase reactant (ESR).
Timepoint [34] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [35] 0 0
Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [35] 0 0
ACR50 response: = 50% improvement in tender joint count; = =50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 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 acute phase reactant (ESR).
Timepoint [35] 0 0
Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [36] 0 0
Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Assessment method [36] 0 0
ACR50 response: = 50% improvement in tender joint count; = =50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 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 acute phase reactant (ESR).
Timepoint [36] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [37] 0 0
Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [37] 0 0
ACR70 response: = 70% improvement in tender joint count; = =70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 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 acute phase reactant (ESR).
Timepoint [37] 0 0
Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [38] 0 0
Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Assessment method [38] 0 0
ACR70 response: = 70% improvement in tender joint count; = =70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 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 C-Reactive Protein CRP.
Timepoint [38] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [39] 0 0
Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36
Assessment method [39] 0 0
ACR90 response: = 90% improvement in tender joint count; = =90% improvement in swollen joint count; and = at least 90% improvement in 3 of the following 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 acute phase reactant (ESR).
Timepoint [39] 0 0
Weeks 4, 8, 12, 20, 28 and 36
Secondary outcome [40] 0 0
Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Assessment method [40] 0 0
ACR90 response: = 90% improvement in tender joint count; = 90% improvement in swollen joint count; and = 90% 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 acute phase reactant (ESR).
Timepoint [40] 0 0
Weeks 36, 40, 48, 56, 64, 72, 80 and 88
Secondary outcome [41] 0 0
DAS28 at Week 36
Assessment method [41] 0 0
The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm).
Timepoint [41] 0 0
Week 36

Eligibility
Key inclusion criteria
* Diagnosis of rheumatoid arthritis.
* Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
* Active rheumatoid arthritis at the time of screening.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
* Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
* Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
834
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Campsie
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Kogarah
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Daw Park
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Heidelberg West
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Malvern
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Victoria Park
Recruitment postcode(s) [1] 0 0
2194 - Campsie
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5041 - Daw Park
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [6] 0 0
3145 - Malvern
Recruitment postcode(s) [7] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Liege
Country [4] 0 0
Belgium
State/province [4] 0 0
Yvoir
Country [5] 0 0
Chile
State/province [5] 0 0
Region Metropolitana
Country [6] 0 0
Colombia
State/province [6] 0 0
Atlantico
Country [7] 0 0
Colombia
State/province [7] 0 0
Cundinamarca
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Brno
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Bruntal
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 2
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha 5
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Zlin
Country [13] 0 0
Former Serbia and Montenegro
State/province [13] 0 0
Belgrade
Country [14] 0 0
Former Serbia and Montenegro
State/province [14] 0 0
Niska Banja
Country [15] 0 0
France
State/province [15] 0 0
Corbeil-Essonnes
Country [16] 0 0
France
State/province [16] 0 0
Le Kremlin Bicetre
Country [17] 0 0
France
State/province [17] 0 0
Le Mans
Country [18] 0 0
France
State/province [18] 0 0
Montpellier
Country [19] 0 0
France
State/province [19] 0 0
Nice
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Strasbourg
Country [22] 0 0
France
State/province [22] 0 0
Toulouse
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg-Eilbek
Country [25] 0 0
Germany
State/province [25] 0 0
Koeln
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Germany
State/province [27] 0 0
Wuerzburg
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Debrecen
Country [30] 0 0
Hungary
State/province [30] 0 0
Szombathely
Country [31] 0 0
Italy
State/province [31] 0 0
CT
Country [32] 0 0
Italy
State/province [32] 0 0
TO
Country [33] 0 0
Italy
State/province [33] 0 0
Roma
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Daejeon
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Incheon
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Korea
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Anyang-si Gyeonggi-do
Country [39] 0 0
Mexico
State/province [39] 0 0
Yucatan
Country [40] 0 0
Mexico
State/province [40] 0 0
Guadalajara
Country [41] 0 0
Mexico
State/province [41] 0 0
Mexico City
Country [42] 0 0
Mexico
State/province [42] 0 0
Mexico DF
Country [43] 0 0
Mexico
State/province [43] 0 0
Monterrey
Country [44] 0 0
Mexico
State/province [44] 0 0
Queretaro
Country [45] 0 0
Netherlands
State/province [45] 0 0
Heerlen
Country [46] 0 0
Poland
State/province [46] 0 0
Bydgoszcz
Country [47] 0 0
Poland
State/province [47] 0 0
Lodz
Country [48] 0 0
Poland
State/province [48] 0 0
Lublin
Country [49] 0 0
Poland
State/province [49] 0 0
Szczecin
Country [50] 0 0
Poland
State/province [50] 0 0
Warszawa
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Moscow
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
St. Petersburg
Country [54] 0 0
Spain
State/province [54] 0 0
A Coruña
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
La Coruña
Country [57] 0 0
Spain
State/province [57] 0 0
Malaga
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Sweden
State/province [59] 0 0
Falun
Country [60] 0 0
Sweden
State/province [60] 0 0
Oskarström
Country [61] 0 0
Taiwan
State/province [61] 0 0
ROC
Country [62] 0 0
Taiwan
State/province [62] 0 0
Kaohsiung City
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Lancashire
Country [64] 0 0
United Kingdom
State/province [64] 0 0
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/NCT00565409