Clinical trial NCT00484536: Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: CDP323
Relapsing Multiple Sclerosis
Magnetic Resonance Imaging
Oral Compound
MS
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2007-06-11
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).
timeFrame: Cumulative number of newly active lesions from baseline to Week 28.
Secondary outcomes:
measure: Occurrence of any treatment emergent adverse event.
timeFrame: During up to 24 weeks of treatment.
Other outcomes:
Locations:
city: Cullman
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Springs
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Maitland
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Northbrook
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Lenexa
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Farmington Hills
country: United States
state: Michigan
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Providence
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Kirkland
country: United States
state: Washington
city: Charleston
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Diepenbeek
country: Belgium
city: Gent
country: Belgium
city: Melsbroek
country: Belgium
city: Overpelt
country: Belgium
city: Sijsele
country: Belgium
city: Sint-Truiden
country: Belgium
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Gatineau
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Besancon
country: France
city: Clermont-Ferrand
country: France
city: Lyon Cedex 03
country: France
city: Rennes
country: France
city: Strasbourg
country: France
city: Bayreuth
country: Germany
city: Berlin
country: Germany
city: Giessen
country: Germany
city: Hamburg
country: Germany
city: Marburg
country: Germany
city: Rostock
country: Germany
city: Ulm
country: Germany
city: Wiesbaden
country: Germany
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Nijmegen
country: Netherlands
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Girona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Oviedo
country: Spain
city: Santa Cruz de Tenerife
country: Spain
city: Sevilla
country: Spain
city: Goteborg
country: Sweden
city: Umea
country: Sweden
city: Hartshill
country: United Kingdom
city: Newcastle
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: