Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00484536
• Date of registration: 08/06/2007
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
• Scientific title: Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.
• Date of first enrolment: May 2007
• Target sample size: 232
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00484536
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Finland, France, Germany, Hungary, Netherlands, Spain, Sweden, United Kingdom, United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: placebo

Drug: CDP323

Primary Outcome(s)

The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28). [Time Frame: Cumulative number of newly active lesions from baseline to Week 28.]

Secondary Outcome(s)

Occurrence of any treatment emergent adverse event. [Time Frame: During up to 24 weeks of treatment.]

Secondary ID(s)

2006-002204-33

C32322

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen Idec