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.

First Received: March 28, 2008 No Changes Posted

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

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 NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Immunoglobulins Adalimumab Globulin, Immune

U.S. FDA Resources

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

No publications provided

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 History of Changes
Health Authority:	Germany: Ministry of Health

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Antibodies, Monoclonal
Antibodies
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Antirheumatic Agents
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Rheumatic Diseases

Adalimumab
Pharmacologic Actions
Antibodies, Monoclonal
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2009