Back to resultsA Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Completion of a previous D2E7 study Subject is in good health (Investigator discretion) with a recent stable medical history Exclusion Criteria: Former enrollment in this trial (DE018) Subject is 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Arm Description
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Outcomes
Primary Outcome Measures
Clinical response indicators
Secondary Outcome Measures
Safety parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233571
Brief Title
A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
Official Title
A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with 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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
796 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Arm Type
Experimental
Arm Description
Adalimumab 40mg subcutaneous (SC) every other week (EOW)
Intervention Type
Biological
Intervention Name(s)
Adalimumab 40 mg subcutaneous (SC) every other week (EOW)
Other Intervention Name(s)
ABT-D2E7, adalimumab, Humira
Primary Outcome Measure Information:
Title
Clinical response indicators
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Safety parameters
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of a previous D2E7 study
Subject is in good health (Investigator discretion) with a recent stable medical history
Exclusion Criteria:
Former enrollment in this trial (DE018)
Subject is 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
Hartmut Kupper, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
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