Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443950
• Other study ID #: 0881A1-319
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2007
• Last updated: December 11, 2007
• Start date: June 2006
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be of Chinese ancestry and living in China.

• Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.

• Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.

Exclusion Criteria:

• Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is ACR20 response at 12 weeks.
Secondary	Physician global assessments
Secondary	Morning stiffness in minutes
Secondary	Pain visual analog scale(VAS)
Secondary	Health assessment questionnaire(HAQ)
Secondary	C-reactive protein (CRP) values, Subject global assessments
Secondary	Number of tender and swollen joints
Secondary	ACR20 (at visit other than week 12)
Secondary	ACR50
Secondary	ACR70 responses