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

NCT ID: NCT00484536

Last Updated: 2011-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-07-31

Brief Summary

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

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CDP323 1000 mg/day

Group Type EXPERIMENTAL

CDP323

Intervention Type DRUG

250 mg capsules, 500 mg bid (1000 mg/day)

CDP323 500 mg/day

Group Type EXPERIMENTAL

CDP323

Intervention Type DRUG

250 mg Capsules, 500 mg, once daily

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

capsules, once daily

Interventions

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CDP323

250 mg capsules, 500 mg bid (1000 mg/day)

Intervention Type DRUG

placebo

capsules, once daily

Intervention Type DRUG

CDP323

250 mg Capsules, 500 mg, once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role collaborator

UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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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

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Sheffield, , United Kingdom

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Countries

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

Other Identifiers

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2006-002204-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C32322

Identifier Type: -

Identifier Source: org_study_id

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