A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis - Full Text View

Sponsor:	Centocor, Inc.
Collaborator:	Centocor BV
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00207727

Purpose

The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis

Condition	Intervention	Phase
Multiple Sclerosis	Drug: CNTO 1275	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase II, Double-blind, Placebo-Controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40(CNTO1275) in Subjects With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Ustekinumab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23. [ Time Frame: Week 23 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relapses of Multiple Sclerosis (MS) Through Week 23 [ Time Frame: Week 23 ] [ Designated as safety issue: No ]
Change From Baseline in Expanded Disability Status Scale (EDSS) [ Time Frame: Week 23 ] [ Designated as safety issue: No ]

Enrollment:	249
Study Start Date:	July 2004
Study Completion Date:	August 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS, inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are quite variable and may range from being mild to severe and from short to long lasting. People with MS may have a wide variety of symptoms ranging from mild to disabling. Some of thesymptoms of MS include visual disturbances such as double vision, weakness in arms or legs,difficulty with coordination, fatigue, changes in sensations such as numbness and tingling, or difficulties with concentration or memory.The drug being tested in this research study is an antibody called CNTO 1275. Antibodies are natural substances made by the body that stick to and react with other substances in the body that may cause diseases. The body makes antibodies mainly to fight infections. CNTO 1275 is an antibody that has been manufactured in the laboratory. In the test tube, CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).Higher than normal levels of IL-12 have been found in people who have MS. CNTO 1275 has been tested in animals with a condition similar to MS. In those animals, IL-12 was over-produced.Animals treated with CNTO 1275 showed decreased symptoms of the condition.The purpose of this study is to better understand the safety and effectiveness of CNTO 1275 in people who have relapsing-remitting MS

Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks 7 and 15.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a definite diagnosis of Relapsing remitting Multiple Sclerosis
Have a history of at least 1 of the following:a. A minimum of 2 relapses of MS within the previous 2 years but not within the 1-month period prior to screening. b. A relapse of MS within the previous 6 months but not within the 1-monthperiod prior to screening

Exclusion Criteria:

Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous)
Have significant bulbar involvement of MS or other neurologic deficits
Have a decubitus ulcer
Have received immunomodulatory therapies within 3 months of screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207727

Sponsors and Collaborators

Centocor, Inc.

Centocor BV

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

No publications provided by Centocor, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Robinson D Jr, Zhao N, Gathany T, Kim LL, Cella D, Revicki D. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin. 2009 May;25(5):1121-30.

Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH; Ustekinumab MS Investigators. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol. 2008 Sep;7(9):796-804.

ClinicalTrials.gov Identifier:	NCT00207727 History of Changes
Other Study ID Numbers:	CR005284
Study First Received:	September 13, 2005
Results First Received:	October 25, 2009
Last Updated:	October 25, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Multiple Sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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 February 09, 2012