Interferon ß-1b Treatment by Cyclical Administration

Study Overview
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Brief Summary
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The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. The 8 MUI dose at alternate days is kept constant for years. About 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. The main objective of the study is to verify the safety and effectiveness of a cyclical administration (a month of suspension after two of treatment) from the beginning of treatment. There is the possibility that a scheme envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising the drug therapeutic effect) compared to the standard administration protocol. This might also result in an increase of the drug effectiveness and/or in a longer duration of effectiveness itself. Finally, cyclical administration allows patients to spend actual periods of therapeutic vacation, with positive psychological effects.

Official Title
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Effect of Cyclical Administration of Interferon β-1b in Multiple Sclerosis - Comparison With Normal Dose.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon-ß-1b
* Drug: Interferon ß-1b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients affected by remitting Multiple Sclerosis who had at least a relapse in the last year of the disease. Satisfying general clinical conditions according to the researcher. Adequate hepatic function. Capacity to use adequate contraceptive techniques during the study. Exclusion Criteria: Any other disease that might better explain signs and symptoms of the patient. Any other disability condition that might interfere with the clinical evolution. History of hypersensitivity to natural or recombinant interferon or to human albumin. Clinically significant heart diseases and not controlled like dysrhythmias, angina pectoris or congestive heart failure. Not adequately controlled epilepsy. Inability, according to the examining commission, to grant a complete compliance with the protocol requirements for the whole study. Previous therapies modifying the disease course in the last six months. Steroid therapies in the last 3 months. Pregnancy, lactation, serological positivity to the pregnancy test during the screening period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interferon beta cyclical administration<br>Interferon ß-1b Treatment by Cyclical Administration | Drug: Interferon-ß-1b<br>* 250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months<br>|
| Active Comparator: Interferon ß-1b Treatment<br>Interferon ß-1b Treatment | Drug: Interferon ß-1b<br>* 250 micrograms (8 MIU) administered subcutaneously (sc) every other day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of gad-enhancing lesions (CELs) in T1 | Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs | baseline and after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of new and enlarging T2 lesions | Group (cyclic withdrawal vs full regimen) differences in new and enlarging T2 lesions | baseline and after 12 months | 
| volume of T1 lesions (black holes) | Group (cyclic withdrawal vs full regimen) differences in T1 lesion volume (black holes) | baseline and after 12 months | 
| relapse rate | Group (cyclic withdrawal vs full regimen) differences in relapse rate | baseline and after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Interferon-ß-1b, Therapy