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

November 28, 2007
August 4, 2015
March 2008
May 2011   (final data collection date for primary outcome measure)
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.
Disease Activity Score (DAS28) over 88 weeks. [ Time Frame: 88 weeks ]
Complete list of historical versions of study NCT00565409 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
Not Provided
Not Provided
 
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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).

  • Drug: Etanercept
    Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
  • Drug: Placebo
    Subcutaneous (SC), once weekly from week 36 to week 88.
  • Active Comparator: 1
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Active Comparator: 2
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Placebo Comparator: 3
    Interventions:
    • Drug: Placebo
    • Drug: Methotrexate
Smolen JS, Nash P, Durez P, Hall S, Ilivanova E, Irazoque-Palazuelos F, Miranda P, Park MC, Pavelka K, Pedersen R, Szumski A, Hammond C, Koenig AS, Vlahos B. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet. 2013 Mar 16;381(9870):918-29. doi: 10.1016/S0140-6736(12)61811-X. Epub 2013 Jan 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
834
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Chile,   Colombia,   Czech Republic,   Former Serbia and Montenegro,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
Serbia,   Brazil,   Korea, Democratic People's Republic of
 
NCT00565409
0881A1-4423, B1801003
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP