Back to resultsAdalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
adalimumab
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 Subject must be in paid employment Subject has self-reported work impairment since onset of symptoms Exclusion Criteria: A subject has chronic arthritis diagnosed before age 16 years. Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs Subject has preceding treatment with any biological TNF antagonist 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
Job loss measurement
Secondary Outcome Measures
Job productivity measurements
Patient reported outcomes
DAS28
Safety parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234845
Brief Title
Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
Official Title
A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis
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 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
adalimumab
Intervention Type
Drug
Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
Job loss measurement
Secondary Outcome Measure Information:
Title
Job productivity measurements
Title
Patient reported outcomes
Title
DAS28
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
Subject must be in paid employment
Subject has self-reported work impairment since onset of symptoms
Exclusion Criteria:
A subject has chronic arthritis diagnosed before age 16 years.
Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
Subject has preceding treatment with any biological TNF antagonist
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
Beverly Paperiello
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information - Abbott
City
Abbott Park
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27338778
Citation
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Results Reference
derived
Learn more about this trial
Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
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