A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Centocor BV
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00207727
First received: September 13, 2005
Last updated: April 20, 2012
Last verified: April 2012
  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 2

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:


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 ]
    A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.


Secondary Outcome Measures:
  • Relapses of Multiple Sclerosis (MS) Through Week 23 [ Time Frame: Week 23 ] [ Designated as safety issue: No ]
    Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS.

  • Change From Baseline in Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline, Week 23 ] [ Designated as safety issue: No ]
    The EDSS is based on an independent neurologist's examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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: April 20, 2012
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 August 21, 2014