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. 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
Information provided by (Responsible Party):
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

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

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

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

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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00484536

  Hide Study Locations
United States, Alabama
Cullman, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Colorado
Springs, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Maitland, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Northbrook, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
United States, Kansas
Kansas City, Kansas, United States
Lenexa, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Michigan
Farmington Hills, Michigan, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
United States, Washington
Kirkland, Washington, United States
United States, West Virginia
Charleston, West Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Diepenbeek, Belgium
Gent, Belgium
Melsbroek, Belgium
Overpelt, Belgium
Sijsele, Belgium
Sint-Truiden, Belgium
Canada, Ontario
London, Ontario, Canada
Ottawa, Ontario, Canada
Canada, Quebec
Gatineau, Quebec, Canada
Greenfield Park, Quebec, Canada
Sherbrooke, Quebec, Canada
Oulu, Finland
Tampere, Finland
Turku, Finland
Besancon, France
Clermont-Ferrand, France
Lyon Cedex 03, France
Rennes, France
Strasbourg, France
Bayreuth, Germany
Berlin, Germany
Giessen, Germany
Hamburg, Germany
Marburg, Germany
Rostock, Germany
Ulm, Germany
Wiesbaden, Germany
Budapest, Hungary
Gyor, Hungary
Nyiregyhaza, Hungary
Pecs, Hungary
Amsterdam, Netherlands
Breda, Netherlands
Nieuwegein, Netherlands
Nijmegen, Netherlands
Barcelona, Spain
Bilbao, Spain
Girona, Spain
Madrid, Spain
Malaga, Spain
Oviedo, Spain
Santa Cruz de Tenerife, Spain
Sevilla, Spain
Goteborg, Sweden
Umea, Sweden
United Kingdom
Hartshill, United Kingdom
Newcastle, United Kingdom
Nottingham, United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Responsible Party: UCB Pharma Identifier: NCT00484536     History of Changes
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:
Relapsing Multiple Sclerosis
Magnetic Resonance Imaging
Oral Compound

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