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

Rheumatoid Arthritis Clinical Trial

— PROWD  

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00650390
• Other study ID #: M02-532
• Status: Approved for marketing
• Phase: N/A
• First received: March 28, 2008
• Last updated: March 28, 2008

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

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

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• 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