Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

NCT00650026 | Unknown

• 1 other identifier: M03-583
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis

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:

• Eighteen years or older
• Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
• Females - negative pregnancy test at screening
• Confirmed diagnosis of active RA \>= 6 swollen joints and \>= 9 tender joints
• Met ACR criteria for diagnosis of RA for at least 3 months
• Active RA defined by a DAS \>= 3.2 at study entry

You may not qualify if:

• Subject had prior treatment with cyclophosphamide or chlorambucil
• Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
• Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
• Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin

Sponsors & Collaborators

• Abbott: lead

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 27, 2008
• First Posted: April 1, 2008
• Last Updated: April 14, 2008

Record last verified: 2008-04