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

NCT00650390 | Unknown

• 1 other identifier: M02-532
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Interventions

adalimumab BIOLOGICAL

40 mg adalimumab every other week

Also known as: ABT-D2E7, Humira

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Related Publications (1)

• 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.

  PMID: 27338778 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Last Updated: April 1, 2008

Record last verified: 2008-03