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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- safety and tolerability
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- 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
Outcomes
Primary Outcomes
safety and tolerability
relapse rate
number of T2 godolinium enhencing lesions on MRI
expanded disease severity score (EDSS)
multiple sclerosis functional composite(MSFC)
Secondary Outcomes
No secondary outcomes reported