Interferon ß-1b Treatment by Cyclical Administration

Sponsor

S. Andrea Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00270816

Collaborator

Italian Multiple Sclerosis Foundation (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Interferon-ß-1b Drug: Interferon ß-1b	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: interferon beta cyclical administration

Interferon ß-1b Treatment by Cyclical Administration

Drug: Interferon-ß-1b

250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months

Active Comparator: Interferon ß-1b Treatment

Interferon ß-1b Treatment

Drug: Interferon ß-1b

250 micrograms (8 MIU) administered subcutaneously (sc) every other day

Outcome Measures

Primary Outcome Measures

number of gad-enhancing lesions (CELs) in T1 [baseline and after 12 months]
Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs

Secondary Outcome Measures

number of new and enlarging T2 lesions [baseline and after 12 months]
Group (cyclic withdrawal vs full regimen) differences in new and enlarging T2 lesions
volume of T1 lesions (black holes) [baseline and after 12 months]
Group (cyclic withdrawal vs full regimen) differences in T1 lesion volume (black holes)
relapse rate [baseline and after 12 months]
Group (cyclic withdrawal vs full regimen) differences in relapse rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.