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Trial record 1 of 1 for:    NCT00726648
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CDP323 Biomarker Study

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: NCT00726648
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : September 12, 2011
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
Comparison of the effects of different CDP323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: CDP323 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.
Study Start Date : July 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: CDP323
250mg capsules, 1000mg daily for 4 weeks

Drug: Placebo
placebo capsules for 4 weeks
Experimental: 2 Drug: CDP323
50mg capsules, 100mg bid for 4 weeks

Drug: Placebo
placebo capsules for 4 weeks
Experimental: 3 Drug: CDP323
250mg capsules, 500mg bid for 4 weeks

Drug: Placebo
placebo capsules for 4 weeks
Experimental: 4 Drug: CDP323
250mg capsules, 1000mg bid for 4 weeks

Drug: Placebo
placebo capsules for 4 weeks
Placebo Comparator: 5 Drug: Placebo
placebo capsules for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacodynamic parameters related to leukocyte trafficking [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Standard and disease-related safety variables [ Time Frame: 4 weeks ]
  2. Class-related safety parameters [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male subjects aged 18-65 years
  • Relapsing form of MS with at least one clinical relapse in the 24 months before screening;
  • Screening EDSS score of 0-6.5;
  • Must be fully immunocompetent
  • Female subjects of childbearing potential must agree to practice contraception methods

Exclusion Criteria:

  • Any conditions that could interfere with the contrast-enhanced MRI;
  • Any clinically significant disease state or findings other than MS;
  • Any clinically significant deviation from the pre-defined ranges for laboratory tests;
  • Concomitant treatment with MS disease modifying drugs
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): NCT00726648


Locations
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United Kingdom
Tooting, London, United Kingdom
Croydon, Surrey, United Kingdom
Sponsors and Collaborators
UCB Pharma
Biogen
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00726648    
Other Study ID Numbers: C32325
EudraCT 2008-000147-34
IND 74863
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: August 2009
Keywords provided by UCB Pharma:
CDP323
Relapsing multiple sclerosis
Blood biomarkers
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