Combination Therapy of Betaseron-Prograf in Multiple Sclerosis
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Interferon beta-1b and Tacrolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- safety and tolerability
- relapse rate
- number of T2 godolinium enhencing lesions on MRI
- expanded disease severity score (EDSS)
- multiple sclerosis functional composite(MSFC)
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | September 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Quebec | |
| Clinique de sclérose en plaques et neuromusculaire | |
| Gatineau, Quebec, Canada, J8Y 1W7 | |
| Principal Investigator: | François Jacques | Multiple Sclerosis Clinic - Hull Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00298662 History of Changes |
| Other Study ID Numbers: | 137-020826 |
| Study First Received: | March 2, 2006 |
| Last Updated: | March 2, 2006 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Clinique de sclérose en plaques et neuromusculaire de l'Outaouais:
|
Multiple Sclerosis Betaseron-Prograf patients of Multiple Sclerosis Secondary Progressive type Relapsing-Remitting type |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta Interferons |
Tacrolimus Interferon beta-1b Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Immunosuppressive Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 19, 2013