Combination Therapy of Betaseron-Prograf in Multiple Sclerosis

NCT00298662 | Unknown Phase 2

• 1 other identifier: 137-020826
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Betaseron-Prograf; patients of Multiple Sclerosis; Secondary Progressive type; Relapsing-Remitting type

Outcome Measures

Primary Outcomes (5)

• safety and tolerability

• relapse rate

• number of T2 godolinium enhencing lesions on MRI

• expanded disease severity score (EDSS)

• multiple sclerosis functional composite(MSFC)

Interventions

Interferon beta-1b and Tacrolimus DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• any of the following conditions: diabetes mellitus, uncontrolled hypertension, active infection or viral diseases

Sponsors & Collaborators

• Clinique de sclérose en plaques et neuromusculaire de l'Outaouais: lead

Study Sites (1)

Clinique de sclérose en plaques et neuromusculaire

Gatineau, Quebec, J8Y 1W7, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b; Tacrolimus

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Macrolides; Lactones; Organic Chemicals

Study Officials

• François Jacques

  Multiple Sclerosis Clinic - Hull Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 3, 2006
• Study Start: February 1, 2003
• Study Completion: September 1, 2006
• Last Updated: March 3, 2006

Record last verified: 2005-09

Locations

CA (1)