Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00443950

Purpose

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.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: Etanercept	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary endpoint is ACR20 response at 12 weeks.

Secondary Outcome Measures:

Physician global assessments
Morning stiffness in minutes
Pain visual analog scale(VAS)
Health assessment questionnaire(HAQ)
C-reactive protein (CRP) values, Subject global assessments
Number of tender and swollen joints
ACR20 (at visit other than week 12)
ACR50
ACR70 responses

Estimated Enrollment:	150
Study Start Date:	June 2006
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443950

Locations

China

Beijing, China, 100853

Shanghai, China, 200001

Beijing, China, 100044

Beijing, China, 100029

Xian, China, 710032

Guangzhou, China, 510275

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0881A1-319
Study First Received:	March 5, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00443950
Health Authority:	China: State Food and Drug Administration

Keywords provided by Wyeth:

Arthritis
Chinese

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases

Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009