Interferon ß-1b Treatment by Cyclical Administration

December 17, 2018 updated by: Giovanni Ristori, S. Andrea Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00139
        • Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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
Drug: Interferon ß-1b
250 micrograms (8 MIU) administered subcutaneously (sc) every other day

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S. Andrea Hospital

Collaborators

Italian Multiple Sclerosis Foundation

Investigators

  • Study Director: Marco Salvetti, MD, S.Andrea Hospital, University of Rome "La Sapienza"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2005

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 27, 2005

First Submitted That Met QC Criteria

December 27, 2005

First Posted (Estimate)

December 28, 2005

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU - CYC - 06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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