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Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Registration Number
NCT00234936
Lead Sponsor
Abbott
Brief Summary

The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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 ACR criteria
  • Subjects with treatment failure criteria to Mtx or Mtx + another DMARD
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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
  • Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
QOL12 months
Secondary Outcome Measures
NameTimeMethod
Patient reported outcomes
Clinical response indicators
Safety parameters
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