Rheumatoid Arthritis Clinical Trial
Official title:
Quality of Life Study With Adalimumab in Rheumatoid Arthritis
Verified date | October 2007 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QOL | 12 months | ||
Secondary | Patient reported outcomes | |||
Secondary | Clinical response indicators | |||
Secondary | Safety parameters |
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