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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Etanercept
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Chinese

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Outcomes

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

Full Information

First Posted
March 5, 2007
Last Updated
December 11, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00443950
Brief Title
Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Arthritis, Chinese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Etanercept
Primary Outcome Measure Information:
Title
The primary endpoint is ACR20 response at 12 weeks.
Secondary Outcome Measure Information:
Title
Physician global assessments
Title
Morning stiffness in minutes
Title
Pain visual analog scale(VAS)
Title
Health assessment questionnaire(HAQ)
Title
C-reactive protein (CRP) values, Subject global assessments
Title
Number of tender and swollen joints
Title
ACR20 (at visit other than week 12)
Title
ACR50
Title
ACR70 responses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Beijing
ZIP/Postal Code
100029
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Guangzhou
ZIP/Postal Code
510275
Country
China
City
Shanghai
ZIP/Postal Code
200001
Country
China
City
Xian
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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