Back to resultsQuality of Life Study With Adalimumab in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adalimumab
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, adalimumab, quality of life
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 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
Sites / Locations
Outcomes
Primary Outcome Measures
QOL
Secondary Outcome Measures
Patient reported outcomes
Clinical response indicators
Safety parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234936
Brief Title
Quality of Life Study With Adalimumab in Rheumatoid Arthritis
Official Title
Quality of Life Study With Adalimumab in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (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 ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, adalimumab, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (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
QOL
Time Frame
12 months
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Quality of Life Study With Adalimumab in Rheumatoid Arthritis
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