Back to resultsStudy Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methotrexate plus ENBREL or ENBREL alone
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: In the case of contra-indications for MRI, the patient may participate in the remaining part of the project. Exclusion Criteria: N/A
Sites / Locations
Outcomes
Primary Outcome Measures
To assess the efficacy and safety of substituting ENBREL versus adding ENBREL to Methotrexate in patients with active Rheumatoid Arthritis despite adequate Methotrexate therapy.
Secondary Outcome Measures
To evaluate the effect of combination therapy with ENBREL plus Methotrexate versus ENBREL alone on health-related quality of life measures.
Full Information
NCT ID
NCT00244556
First Posted
October 12, 2005
Last Updated
February 20, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00244556
Brief Title
Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy
Official Title
A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To investigate the changes in MRI-derived markers of joint inflammation and destruction and in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid arthritis patients treated with Enbrel and Enbrel+methotrexate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methotrexate plus ENBREL or ENBREL alone
Primary Outcome Measure Information:
Title
To assess the efficacy and safety of substituting ENBREL versus adding ENBREL to Methotrexate in patients with active Rheumatoid Arthritis despite adequate Methotrexate therapy.
Secondary Outcome Measure Information:
Title
To evaluate the effect of combination therapy with ENBREL plus Methotrexate versus ENBREL alone on health-related quality of life measures.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
In the case of contra-indications for MRI, the patient may participate in the remaining part of the project.
Exclusion Criteria:
N/A
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
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy
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