- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443950
Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis
December 11, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
150
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
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Beijing, China, 100044
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Beijing, China, 100029
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Beijing, China, 100853
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Guangzhou, China, 510275
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Shanghai, China, 200001
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Xian, China, 710032
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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 |
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The primary endpoint is ACR20 response at 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
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Physician global assessments
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Morning stiffness in minutes
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Pain visual analog scale(VAS)
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Health assessment questionnaire(HAQ)
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C-reactive protein (CRP) values, Subject global assessments
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Number of tender and swollen joints
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ACR20 (at visit other than week 12)
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ACR50
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ACR70 responses
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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, 2006
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
March 5, 2007
First Submitted That Met QC Criteria
March 5, 2007
First Posted (Estimate)
March 7, 2007
Study Record Updates
Last Update Posted (Estimate)
December 13, 2007
Last Update Submitted That Met QC Criteria
December 11, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- 0881A1-319
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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