Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis (PRESERVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00565409
First received: November 28, 2007
Last updated: August 4, 2015
Last verified: August 2015
  Purpose

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Etanercept
Drug: Methotrexate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28, 36 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving DAS28 Low Disease Activity or Remission [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28 [ Time Frame: Week 36 up to Week 88 ] [ Designated as safety issue: No ]
    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.

  • Time to Loss of Low Disease Activity DAS28 [ Time Frame: Week 36 up to Week 88 ] [ Designated as safety issue: No ]
    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.

  • Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88 [ Time Frame: Week 36 up to Week 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • Prorated Swollen Joint Count at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    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.

  • Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • Painful Joint Count at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    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.

  • Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • PGA Score at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.

  • Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • PtGA of Arthritis Pain at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    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 From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80, 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • Duration of Morning Stiffness at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    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.

  • Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80, 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • General Health at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    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.

  • Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80, 88 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Baseline, Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • Pain at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    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.

  • Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36 [ Time Frame: Baseline, Week 36 ] [ Designated as safety issue: No ]
    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?).

  • Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88 [ Time Frame: Weeks 36, 64 and 88 ] [ Designated as safety issue: No ]
    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?).

  • Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Week 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36 [ Time Frame: Weeks 4, 8, 12, 20, 28 and 36 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 [ Time Frame: Weeks 36, 40, 48, 56, 64, 72, 80 and 88 ] [ Designated as safety issue: No ]
    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).

  • DAS28 at Week 36 [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    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).


Enrollment: 834
Study Start Date: March 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Etanercept
Subcutaneous (SC), 50 mg, once weekly for 88 weeks
Other Name: Enbrel
Drug: 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).

Active Comparator: 2 Drug: Etanercept
Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
Drug: 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).

Placebo Comparator: 3 Drug: Placebo
Subcutaneous (SC), once weekly from week 36 to week 88.
Drug: 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).


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565409

  Hide Study Locations
Locations
Australia, New South Wales
Pfizer Investigational Site
Campsie, New South Wales, Australia, 2194
Pfizer Investigational Site
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Pfizer Investigational Site
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Pfizer Investigational Site
Daw Park, South Australia, Australia, 5041
Australia, Victoria
Pfizer Investigational Site
Heidelberg West, Victoria, Australia, 3081
Pfizer Investigational Site
Malvern, Victoria, Australia, 3145
Australia
Pfizer Investigational Site
Victoria Park, Australia, 6100
Austria
Pfizer Investigational Site
Wien, Austria, 1130
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1200
Pfizer Investigational Site
Liege, Belgium, 4000
Pfizer Investigational Site
Yvoir, Belgium, 5530
Chile
Pfizer Investigational Site
Santiago, Region Metropolitana, Chile
Colombia
Pfizer Investigational Site
Barranquilla, Atlantico, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 656 91
Pfizer Investigational Site
Bruntal, Czech Republic, 792 01
Pfizer Investigational Site
Bruntal, Czech Republic, 79201
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Pfizer Investigational Site
Praha 5, Czech Republic, 150 06
Pfizer Investigational Site
Zlin, Czech Republic, 760 01
Former Serbia and Montenegro
Pfizer Investigational Site
Belgrade, Former Serbia and Montenegro, 11000
Pfizer Investigational Site
Niska Banja, Former Serbia and Montenegro, 18205
France
Pfizer Investigational Site
Corbeil-Essonnes, France, 91100
Pfizer Investigational Site
Le Kremlin Bicetre, France, 94270
Pfizer Investigational Site
Le Mans, France, 72037
Pfizer Investigational Site
Montpellier, France, 34059
Pfizer Investigational Site
Nice, France, 06202
Pfizer Investigational Site
Paris, France, 75018
Pfizer Investigational Site
Strasbourg, France, 67098
Pfizer Investigational Site
Toulouse, France, 31059
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Hamburg-Eilbek, Germany, 22081
Pfizer Investigational Site
Koeln, Germany, 50937
Pfizer Investigational Site
Leipzig, Germany, 04103
Pfizer Investigational Site
Leipzig, Germany, 4103
Pfizer Investigational Site
Wuerzburg, Germany, 97080
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1023
Pfizer Investigational Site
Debrecen, Hungary, 4012
Pfizer Investigational Site
Debrecen, Hungary, H-4032
Pfizer Investigational Site
Szombathely, Hungary, 9701
Italy
Pfizer Investigational Site
Catania, CT, Italy, 95100
Pfizer Investigational Site
Orbassano, TO, Italy, 10043
Pfizer Investigational Site
Roma, Italy, 00128
Korea, Republic of
Pfizer Investigational Site
Seo-gu, Daejeon, Korea, Republic of, 302-799
Pfizer Investigational Site
Namdong-gu, Incheon, Korea, Republic of, 405-760
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 135-720
Pfizer Investigational Site
Seongdong-gu, Seoul, Korea, Republic of, 133-792
Pfizer Investigational Site
Anyang-si Gyeonggi-do, Korea, Republic of, 431-070
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-729
Pfizer Investigational Site
Seoul, Korea, Republic of, 134-701
Mexico
Pfizer Investigational Site
Merida, Yucatan, Mexico, 97000
Pfizer Investigational Site
Guadalajara, Mexico, 44650
Pfizer Investigational Site
Mexico City, Mexico, 06700
Pfizer Investigational Site
Mexico DF, Mexico, 11500
Pfizer Investigational Site
Monterrey, Mexico, 64020
Pfizer Investigational Site
Queretaro, Mexico, 76000
Netherlands
Pfizer Investigational Site
Heerlen, Netherlands, 6419 PC
Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-168
Pfizer Investigational Site
Lodz, Poland, 93-513
Pfizer Investigational Site
Lublin, Poland, 20-954
Pfizer Investigational Site
Szczecin, Poland, 71-252
Pfizer Investigational Site
Warszawa, Poland
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Moscow, Russian Federation, 119002
Pfizer Investigational Site
Moscow, Russian Federation, 129110
Pfizer Investigational Site
Moscow, Russian Federation
Pfizer Investigational Site
St Petersburg, Russian Federation, 199004
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194291
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 157 06
Pfizer Investigational Site
Sabadell, Barcelona, Spain, 08208
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
La Coruña, Spain, 15006
Pfizer Investigational Site
Malaga, Spain, 29009
Pfizer Investigational Site
Sevilla, Spain, 41009
Sweden
Pfizer Investigational Site
Falun, Sweden, 79182
Pfizer Investigational Site
Oskarström, Sweden, 31392
Taiwan
Pfizer Investigational Site
Tapei City, ROC, Taiwan, 114
Pfizer Investigational Site
Kaohsiung City, Taiwan, 807
United Kingdom
Pfizer Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9EP
Pfizer Investigational Site
Dudley, West Midlands, United Kingdom, DY1 2HQ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00565409     History of Changes
Other Study ID Numbers: 0881A1-4423, B1801003
Study First Received: November 28, 2007
Results First Received: May 7, 2012
Last Updated: August 4, 2015
Health Authority: Australia: Human Research Ethics Committee
France: Institutional Ethical Committee
Hungary: Nation

Keywords provided by Pfizer:
Active Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Immunoglobulin G
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 26, 2015