- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207727
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
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
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.
Time Frame: Week 23
|
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.
|
Week 23
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapses of Multiple Sclerosis (MS) Through Week 23
Time Frame: Week 23
|
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.
|
Week 23
|
Change From Baseline in Expanded Disability Status Scale (EDSS)
Time Frame: Baseline, Week 23
|
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.
|
Baseline, Week 23
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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. doi: 10.1185/03007990902797675.
- 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. doi: 10.1016/S1474-4422(08)70173-X.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005284
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
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University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
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University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
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Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
Clinical Trials on CNTO 1275
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Centocor Research & Development, Inc.CompletedPsoriasisUnited States, United Kingdom, Germany, Canada, Austria, France, Switzerland
-
Johnson & Johnson Pte LtdCompletedPlaque PsoriasisTaiwan, Korea, Republic of, Malaysia, Singapore, Indonesia
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Centocor, Inc.Completed
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Centocor Research & Development, Inc.CompletedPsoriasisUnited States, Belgium, Canada
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Centocor, Inc.CompletedPsoriatic ArthritisUnited States, Canada, Switzerland, Finland, Denmark
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Centocor, Inc.CompletedCrohn DiseaseUnited States, Canada, Belgium
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Centocor, Inc.Completed
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Janssen Research & Development, LLCCompleted
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Janssen-Cilag International NVCompleted