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

Rheumatoid Arthritis Clinical Trial

— ReAct  

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00650026
• Other study ID #: M03-583
• Status: Approved for marketing
• Phase: N/A
• First received: March 27, 2008
• Last updated: April 10, 2008

Study information

• Verified date: April 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Expanded Access

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

N/A

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• adalimumab
40 mg adalimumab every other week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott