- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298662
Combination Therapy of Betaseron-Prograf in Multiple Sclerosis
A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents
The purpose of the study is to evaluate the safety and tolerability of a combination of interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS
Prograf is an immunosuppressant that weakens the immune reactions responsible to protect the organism against infections. It is currently available on the market for patients who have received an organ transplant, to prevent rejection. Because of its effect on the immune system, theoretically, Prograf should exert a significant effect in MS. It has been tried in a small number of MS patients at a lower dose than the one used in organ transplant, however the results of the study did not allow to draw definite conclusions on its safety and efficacy in MS.
Betaseron is approved in Canada for the reduction of the frequency of relapses in patients with relapsing-remitting MS and for the slowing of progression and reduction of the frequency of relapses in patients with secondary-progressive MS. The combination of Betaseron and Prograf may result in an additive effect or an increase in the actions of the drugs. However, the combination of the two drugs has never been studied.
The aim of this study is to see how well the combination of Betaseron and Prograf is tolerated by patients with MS. The side effects of the treatment, if any, will be followed. In addition, the efficacy of the combination will be evaluated.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
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Gatineau, Quebec, Canada, J8Y 1W7
- Clinique de sclérose en plaques et neuromusculaire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- relapsing-remitting or secondary-progressive multiple sclerosis
- patients who have failed treatment with approved immunomodulator drugs (having experienced same or higher annual relapse rate or having experinced progression on the EDSS scale)
- Expanded Disability Status Scale (EDSS) score less than 7.0
Exclusion Criteria:
- any of the following conditions: diabetes mellitus, uncontrolled hypertension, active infection or viral diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
relapse rate
|
safety and tolerability
|
number of T2 godolinium enhencing lesions on MRI
|
expanded disease severity score (EDSS)
|
multiple sclerosis functional composite(MSFC)
|
Collaborators and Investigators
Investigators
- Principal Investigator: François Jacques, Multiple Sclerosis Clinic - Hull Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
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
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Calcineurin Inhibitors
- Interferons
- Tacrolimus
- Interferon-beta
- Interferon beta-1b
Other Study ID Numbers
- 137-020826
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.
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