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Clinical Trials/NCT00234845
NCT00234845CompletedPhase 3

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

Abbott2 sites in 1 country148 target enrollmentStarted: March 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Abbott
Enrollment
148
Locations
2
Primary Endpoint
Job loss measurement
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Job loss measurement

Secondary Outcomes

  • Job productivity measurements
  • DAS28
  • Patient reported outcomes
  • Safety parameters

Investigators

Sponsor
Abbott
Sponsor Class
Industry

Study Sites (2)

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