Back to resultsOpen-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
adalimumab (up to 9 months exposure)
methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria Exclusion Criteria: Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast-feeding or considering becoming pregnant
Sites / Locations
- Global Medical Information - Abbott
Outcomes
Primary Outcome Measures
Corticoid reduction and DAS 28
Secondary Outcome Measures
Patient reported outcomes
Clinical response indicators
Safety parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233558
Brief Title
Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis
Official Title
Multicentre, Randomised, Open Label Study Comparing a "Scheduled Steroid Reduction Strategy" Versus a Free Steroid Reduction Strategy (Physician's Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to low subject enrollment. Safety results consistent with product label.
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
adalimumab (up to 9 months exposure)
Intervention Type
Drug
Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
Corticoid reduction and DAS 28
Secondary Outcome Measure Information:
Title
Patient reported outcomes
Title
Clinical response indicators
Title
Safety parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
Exclusion Criteria:
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information - Abbott
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis
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