Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab - Full Text View

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.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00650390

Purpose

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	Intervention
Rheumatoid Arthritis	Biological: adalimumab

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune Tumor Necrosis Factors

U.S. FDA Resources

Study Type:	Expanded Access
Official Title:	Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Further study details as provided by Abbott:

Intervention Details:

40 mg adalimumab every other week

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Abbott ( Lawrence McNamee )
Study ID Numbers:	M02-532
Study First Received:	March 28, 2008
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00650390
Health Authority:	Germany: Ministry of Health

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009