Study Stopped
The study was discontinued due to unfavorable interim analysis
Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
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.
2 other identifiers
interventional
232
11 countries
71
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
Started May 2007
Typical duration for phase_2 multiple-sclerosis
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 8, 2007
CompletedFirst Posted
Study publicly available on registry
June 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedSeptember 12, 2011
March 1, 2011
2.5 years
June 8, 2007
September 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (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.
Cumulative number of newly active lesions from baseline to Week 28.
Secondary Outcomes (1)
Occurrence of any treatment emergent adverse event.
During up to 24 weeks of treatment.
Study Arms (3)
CDP323 1000 mg/day
EXPERIMENTALCDP323 500 mg/day
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
- Biogencollaborator
Study Sites (71)
Unknown Facility
Cullman, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Springs, Colorado, United States
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Washington D.C., District of Columbia, United States
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Maitland, Florida, United States
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Atlanta, Georgia, United States
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Northbrook, Illinois, United States
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Fort Wayne, Indiana, United States
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Kansas City, Kansas, United States
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Lenexa, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Farmington Hills, Michigan, United States
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Charlotte, North Carolina, United States
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Columbus, Ohio, United States
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Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Kirkland, Washington, United States
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Charleston, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Diepenbeek, Belgium
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Ghent, Belgium
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Melsbroek, Belgium
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Overpelt, Belgium
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Sijsele, Belgium
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Sint-Truiden, Belgium
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Oulu, Finland
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Tampere, Finland
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Turku, Finland
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Besançon, France
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Clermont-Ferrand, France
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Lyon, France
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Rennes, France
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Strasbourg, France
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Bayreuth, Germany
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Berlin, Germany
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Giessen, Germany
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Hamburg, Germany
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Marburg, Germany
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Rostock, Germany
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Ulm, Germany
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Wiesbaden, Germany
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Budapest, Hungary
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Győr, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Amsterdam, Netherlands
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Breda, Netherlands
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Nieuwegein, Netherlands
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Nijmegen, Netherlands
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Barcelona, Spain
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Bilbao, Spain
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Girona, Spain
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Madrid, Spain
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Málaga, Spain
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Oviedo, Spain
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Santa Cruz de Tenerife, Spain
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Seville, Spain
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Gothenburg, Sweden
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Umeå, Sweden
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Hartshill, United Kingdom
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Newcastle, United Kingdom
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Nottingham, United Kingdom
Unknown Facility
Sheffield, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2007
First Posted
June 11, 2007
Study Start
May 1, 2007
Primary Completion
November 1, 2009
Study Completion
July 1, 2010
Last Updated
September 12, 2011
Record last verified: 2011-03