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

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00484536
• Other study ID #: C32322
• Secondary ID: 2006-002204-33
• Status: Terminated
• Phase: Phase 2
• First received: June 8, 2007
• Last updated: September 2, 2011
• Start date: May 2007
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyNetherlands: Medicines Evaluation Board (MEB)Spain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 232
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• CDP323
250 mg capsules, 500 mg bid (1000 mg/day)
• placebo
capsules, once daily
• CDP323
250 mg Capsules, 500 mg, once daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UCB Pharma	Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland,  France,  Germany,  Hungary,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Occurrence of any treatment emergent adverse event.		During up to 24 weeks of treatment.	No