Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)
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:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00650390
Brief Title
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
Acronym
PROWD
Official Title
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 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
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.
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:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
27338778
Citation
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Results Reference
derived
Learn more about this trial
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
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