Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)

This treatment has been approved for sale to the public.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00650390

First received: March 28, 2008

Last updated: NA

Last verified: March 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 28, 2008
Last Updated Date	March 28, 2008
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
Official Title ^ICMJE	Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Expanded Access
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Biological: adalimumab 40 mg adalimumab every other week Other Names: ABT-D2E7 Humira adalimumab
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Approved for marketing
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00650390
Other Study ID Numbers ^ICMJE	M02-532
Has Data Monitoring Committee	Not Provided
Responsible Party	Lawrence McNamee, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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