Back to resultsEarly Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis (ReAct)
Primary Purpose
Rheumatoid Arthritis
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
adalimumab
Sponsored by
About this trial
This is an expanded access trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Eighteen years or older
- Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
- Females - negative pregnancy test at screening
- Confirmed diagnosis of active RA >= 6 swollen joints and >= 9 tender joints
- Met ACR criteria for diagnosis of RA for at least 3 months
- Active RA defined by a DAS >= 3.2 at study entry
Exclusion Criteria:
- Subject had prior treatment with cyclophosphamide or chlorambucil
- Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
- Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
- Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00650026
Brief Title
Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
Acronym
ReAct
Official Title
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active 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
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
40 mg adalimumab every other week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Eighteen years or older
Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
Females - negative pregnancy test at screening
Confirmed diagnosis of active RA >= 6 swollen joints and >= 9 tender joints
Met ACR criteria for diagnosis of RA for at least 3 months
Active RA defined by a DAS >= 3.2 at study entry
Exclusion Criteria:
Subject had prior treatment with cyclophosphamide or chlorambucil
Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin
12. IPD Sharing Statement
Learn more about this trial
Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
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