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

UCB

Status and phase: Terminated; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: CDP323; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00484536

2006-002204-33 (EudraCT Number)

C32322

Details and patient eligibility

About

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

Enrollment: 232 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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232 participants in 3 patient groups, including a placebo group

CDP323 1000 mg/day

Experimental group

Treatment:

Drug: CDP323

Drug: CDP323

CDP323 500 mg/day

Experimental group

Treatment:

Drug: CDP323

Drug: CDP323

Placebo

Placebo Comparator group

Treatment:

Drug: placebo