Overview
Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
Status:
Terminated
Terminated
Trial end date:
2010-07-01
2010-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosisPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
UCB PharmaCollaborator:
Biogen
Criteria
Inclusion Criteria:- relapsing form of MS
- screening EDSS score 0 - 5.5, inclusive
- at least one clinical relapse in the 12 months before screening
- active disease, defined by set of MRI activity criteria
- failed prior treatment with beta-interferons or glatiramer acetate
Exclusion Criteria:
- signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or
Hepatitis C or tuberculosis
- known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation
- pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening
within certain time frames