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Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

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ClinicalTrials.gov Identifier: NCT00422227
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : August 30, 2010
Last Update Posted : August 30, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE January 11, 2007
First Posted Date  ICMJE January 15, 2007
Results First Submitted Date  ICMJE March 31, 2010
Results First Posted Date  ICMJE August 30, 2010
Last Update Posted Date August 30, 2010
Study Start Date  ICMJE June 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks [ Time Frame: 16 weeks ]
ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening. The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2007)
American College of Rheumatology (ACR) response over 16 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2010)
  • Percentage of Participants Achieving ACR 20, 50, and 70 Responses [ Time Frame: Week 16 ]
    Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.
  • Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission) [ Time Frame: Week 16 ]
    Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).
  • Percent Change From Baseline in DAS28 at Week 16 [ Time Frame: Week 16 ]
    Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).
  • Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response [ Time Frame: Week 16 ]
    EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.
  • Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2 [ Time Frame: Week 16 ]
    Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).
  • Percent Change From Baseline in Painful and Swollen Joint Counts [ Time Frame: Week 2, 4, 8, 12, 16 ]
    Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen.
  • Percent Change From Baseline in Physician And Subject Global Assessments [ Time Frame: Week 2, 4, 8, 12, 16 ]
    The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity.
  • Percent Change From Baseline in Duration (Minutes) of Morning Stiffness [ Time Frame: Week 2, 4, 8, 12, 16 ]
    The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.
  • Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales [ Time Frame: Week 2, 4, 8, 12, 16 ]
    VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, "in general how would you rate your heath over the last 2-3 weeks", 0mm equals very well and 100mm equals extremely bad. Pain VAS: "indicate the amount of pain experienced during the last 2-3 days", 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: "how fatigued or tired have you been over the last week", range =No Fatigue - Extremely Fatigued.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
Official Title  ICMJE A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis
Brief Summary The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Etanercept , Methotrexate
    • Etanercept: 25 mg twice weekly over 16 weeks, SC
    • Methotrexate: > 7.5 mg/week and no more than 25 mg/week, PO
  • Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
    • Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
    • Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
    • Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
    • Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily
Study Arms  ICMJE
  • Active Comparator: 1
    Etanercept + Methotrexate
    Intervention: Drug: Etanercept , Methotrexate
  • Active Comparator: 2
    DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
    Intervention: Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2007)
300
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of RA
  • Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
  • Active RA at time of screening and baseline

Exclusion Criteria:

  • Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
  • Concurrent treatment with a DMARD, other than MTX, at screening
  • Receipt of any DMARD, other than MTX, within 3 months before screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   India,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00422227
Other Study ID Numbers  ICMJE 0881A1-408
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Hong Kong: medinfo@wyeth.com
Principal Investigator: Trial Manager For Taiwan: medinfo@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2010

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