Interferon ß-1b Treatment by Cyclical Administration

This study has been completed.
Sponsor:
Collaborator:
Multiple Sclerosis Italian Foundation (FISM)
Information provided by:
S. Andrea Hospital
ClinicalTrials.gov Identifier:
NCT00270816
First received: December 27, 2005
Last updated: February 10, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Interferon-ß-1b
Drug: Interferon ß-1b
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Cyclical Administration of Interferon β-1b in Multiple Sclerosis - Comparison With Normal Dose.

Resource links provided by NLM:


Further study details as provided by S. Andrea Hospital:

Primary Outcome Measures:
  • number of lesions in T1 and new lesions in T2 [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]
  • number of gad-enhancing lesions in T1 [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relapse rate [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]
  • volume of T1 lesions (black holes) [ Time Frame: baseline and after 12 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2005
Study Completion Date: November 2013
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270816

Locations
Italy
Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
Rome, Italy, 00139
Sponsors and Collaborators
S. Andrea Hospital
Multiple Sclerosis Italian Foundation (FISM)
Investigators
Study Director: Marco Salvetti, MD S.Andrea Hospital, University of Rome "La Sapienza"
  More Information

Additional Information:
Publications:

Responsible Party: Marco Salvetti, CENTERS
ClinicalTrials.gov Identifier: NCT00270816     History of Changes
Other Study ID Numbers: NEU - CYC - 06
Study First Received: December 27, 2005
Last Updated: February 10, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by S. Andrea Hospital:
Multiple Sclerosis
Interferon-ß-1b
Therapy

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 14, 2014