Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323

This study is ongoing, but not recruiting participants.

First Received: June 8, 2007 Last Updated: March 23, 2010 History of Changes

Sponsor:	UCB, Inc.
Collaborator:	Biogen Idec
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00484536

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control 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:

MedlinePlus related topics: Multiple Sclerosis

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

To compare the effects of CDP323 on MS-related imaging parameters in subjects with relapsing MS (RMS) with the effects seen under placebo treatment in that population [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare CDP323's tolerability and safety in RMS subjects with placebo treatment in that population [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	279
Study Start Date:	May 2007
Estimated Study Completion Date:	July 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Criteria

Inclusion Criteria:

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

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

Sponsors and Collaborators

UCB, Inc.

Biogen Idec

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

Click here for more information about this study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB ( Study Director )
ClinicalTrials.gov Identifier:	NCT00484536 History of Changes
Other Study ID Numbers:	C32322, EudraCT Number:, 2006-002204-33
Study First Received:	June 8, 2007
Last Updated:	March 23, 2010
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; 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 September 01, 2010