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

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: CDP323; Drug: placebo

• Registration Number: NCT00484536
• Lead Sponsor: UCB Pharma

Brief Summary

The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-08
• Study First Submitted QC: 2007-06-08
• Study First Posted: 2007-06-11
• Primary Completion: 2009-11
• Study Completion: 2010-07
• Disposition First Submitted: 2011-01-20
• Disposition First Submitted QC: 2011-01-20
• Disposition First Posted: 2011-01-28
• Status Verified: 2011-03
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDP323 1000 mg/day	CDP323	-
CDP323 500 mg/day	CDP323	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).	Cumulative number of newly active lesions from baseline to Week 28.	The following lesions are considered newly active: new gadolinium enhancement on T1-weighted images; new lesions on T2-weighted images, but non-enhancing on T1-weighted images; new enlargement on T2-weighted images, but non-enhancing on T1-weighted images.

Secondary Outcome Measures

Name	Time	Method
Occurrence of any treatment emergent adverse event.	During up to 24 weeks of treatment.