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A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
This study has been completed.
Sponsors and Collaborators: Centocor, Inc.
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

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Immunoglobulins Globulin, Immune Interleukin-12 Ustekinumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The cumulative number of newly Gd-enhancing T1-weighted lesions on cranial MRIs throughWeek 23.

Secondary Outcome Measures:
  • The total number of relapses of MS through Week 23; Change from baseline in Expanded Disability Status Scale (EDSS) score at Week 23.

Estimated Enrollment: 250
Study Start Date: July 2004
Estimated Study Completion Date: August 2006
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

Publications indexed to this study:
Study ID Numbers: CR005284
Study First Received: September 13, 2005
Last Updated: October 19, 2007
ClinicalTrials.gov Identifier: NCT00207727  
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Multiple Sclerosis

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Interleukin-12
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009