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

July 28, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
  • India
      • Bangalore, India, 560034
      • Bangalore, India, 560017
      • Hyderabaad, India, 500082
      • New Delhi, India, 110029
  • Korea, Republic of
    • Korea
      • In Cheon, Korea, Korea, Republic of, 400-711
      • Seoul, Korea, Korea, Republic of, 110-744
      • Seoul, Korea, Korea, Republic of, 120-752
      • Seoul, Korea, Korea, Republic of, 133-792
      • Seoul, Korea, Korea, Republic of, 137-701
      • Seoul, Korea, Korea, Republic of, 138-736
  • Malaysia
      • Ipoh, Perak, Malaysia, 30450
      • Kuala Lumpur, Malaysia, 68100
      • Pulau Pinang, Malaysia, 10450
      • Putrajaya, Malaysia, 62250
      • Seremban, Malaysia, 70300
  • Philippines
      • Cebu, Philippines, 6000
      • Makati City, Philippines, 1200
      • Manila, Philippines, 1000
      • Manila, Philippines, 1004
      • Manila, Philippines, 1500
      • Quezon City, Philippines, 1102
  • Singapore
      • Singapore, Singapore, 308433
  • Taiwan
      • Kaohsiung City, Taiwan, 807
      • Taipei, Taiwan, 100
      • Taipei, Taiwan, 112
  • Thailand
      • Bangkok, Thailand, 10400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Etanercept + Methotrexate
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
Active Comparator: 2
DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 16
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).
Week 16
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).
Week 16
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.
Week 16
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).
Week 16
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.
Week 2, 4, 8, 12, 16
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.
Week 2, 4, 8, 12, 16
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.
Week 2, 4, 8, 12, 16
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.
Week 2, 4, 8, 12, 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Hong Kong: medinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Taiwan: medinfo@wyeth.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 11, 2007

First Submitted That Met QC Criteria

January 11, 2007

First Posted (Estimate)

January 15, 2007

Study Record Updates

Last Update Posted (Estimate)

August 30, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A1-408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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