Trial record 1 of 2 for:    cdp323
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Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

This study has been terminated.
(The study was discontinued due to unfavorable interim analysis)
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00484536
First received: June 8, 2007
Last updated: September 2, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: CDP323
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Occurrence of any treatment emergent adverse event. [ Time Frame: During up to 24 weeks of treatment. ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: May 2007
Study Completion Date: July 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484536

  Show 71 Study Locations
Sponsors and Collaborators
UCB, Inc.
Biogen Idec
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00484536     History of Changes
Other Study ID Numbers: C32322, 2006-002204-33
Study First Received: June 8, 2007
Last Updated: September 2, 2011
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: Medicines Evaluation Board (MEB)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency

Keywords provided by UCB, Inc.:
CDP323
Relapsing Multiple Sclerosis
Magnetic Resonance Imaging
Oral Compound
MS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014