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Trial record 1 of 1 for:    NCT00484536
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Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00484536
Recruitment Status : Terminated (The study was discontinued due to unfavorable interim analysis)
First Posted : June 11, 2007
Last Update Posted : September 12, 2011
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: CDP323 Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : May 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CDP323 1000 mg/day Drug: CDP323
250 mg capsules, 500 mg bid (1000 mg/day)
Experimental: CDP323 500 mg/day Drug: CDP323
250 mg Capsules, 500 mg, once daily
Placebo Comparator: Placebo Drug: placebo
capsules, once daily


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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 :
  1. Occurrence of any treatment emergent adverse event. [ Time Frame: During up to 24 weeks of treatment. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484536


Locations
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Sponsors and Collaborators
UCB Pharma
Biogen
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00484536    
Other Study ID Numbers: C32322
2006-002204-33 ( EudraCT Number )
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: March 2011
Keywords provided by UCB Pharma:
CDP323
Relapsing Multiple Sclerosis
Magnetic Resonance Imaging
Oral Compound
MS
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases