Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)
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ClinicalTrials.gov Identifier: NCT00650390 |
Expanded Access Status :
Approved for marketing
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
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Sponsor:
Abbott
Information provided by:
Abbott
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Brief Summary:
The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.
Condition or disease | Intervention/treatment |
---|---|
Rheumatoid Arthritis | Biological: adalimumab |
Study Type : | Expanded Access |
Official Title: | Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Rheumatoid arthritis
Drug Information available for:
Adalimumab
Intervention Details:
- Biological: adalimumab
40 mg adalimumab every other weekOther Names:
- ABT-D2E7
- Humira
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Criteria
Inclusion Criteria:
- Males and females >= 18 years of age
- ACR criteria for RA diagnosis for at least 6 months
- Active RA defined as a DAS 28 >3.2 at study entry
- Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
- A negative pregnancy test for females of childbearing potential
Exclusion Criteria:
- Patient who had previous treatment with cyclophosphamide and chlorambucil
- Treatment within the last 8 weeks with infliximab
- Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
- Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
- History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
- Prior treatment with total lymphoid irradiation
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lawrence McNamee, Abbott |
ClinicalTrials.gov Identifier: | NCT00650390 |
Other Study ID Numbers: |
M02-532 |
First Posted: | April 1, 2008 Key Record Dates |
Last Update Posted: | April 1, 2008 |
Last Verified: | March 2008 |
Additional relevant MeSH terms:
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |