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NCT Number: NCT00484237

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Goshogawara, Aomori, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2007
First posted
Jun 8, 2007
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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