To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• RA > 6 months duration on stable Methotrexate

• ≤9 swollen and ≤9 tender joints (28 joint count)

• Minimum Screening CRP of 0.5mg/L

Exclusion Criteria:

• Participation in previous studies with defined agents and durations

• Previous treatment with defined agents and durations

• Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response

• Pregnancy

• Positive tests/signs of possible latent/active tuberculosis

• Positive HIV

• Drug addiction or alcohol abuse