A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

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

  • Japan
      • Fukuoka, Japan, 810-0001
      • Kumamoto, Japan, 862-0976
      • Nagano, Japan, 380-0928
      • Oita, Japan, 870-0823
    • Aomori
      • Goshogawara, Aomori, Japan, 037-0053
    • Chiba
      • Choseigun, Chiba, Japan, 299-4301
      • Yotsukaido, Chiba, Japan, 284-0003
    • Fukushima
      • Fukushima City, Fukushima, Japan, 960-8251
    • Hiroshima
      • Higashihiroshima, Hiroshima, Japan, 790-0002
    • Hyogo
      • Katoh, Hyogo, Japan, 673-1462
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 228-8522
    • Miyagi
      • Sendai-City, Miyagi, Japan, 982-0032
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-1195

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of >6 swollen joints and >6 tender joints
  • Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
  • Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit

Exclusion Criteria:

  • Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
  • Received investigational drugs within 6 months of the baseline visit
  • Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).

Secondary Outcome Measures

Outcome Measure
ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.

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

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

April 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0881A1-3324

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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