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Completed

NCT Number: NCT00270816

Interferon ß-1b Treatment by Cyclical Administration

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Rome, 00139, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon-ß-1b

Drug

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

Interferon ß-1b

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. relapse rate

    Time frame: baseline and after 12 months

    Group (cyclic withdrawal vs full regimen) differences in relapse rate

Sponsors and collaborators

Lead sponsor

S. Andrea Hospital

Other

Collaborators

  • Italian Multiple Sclerosis Foundation

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Dec 28, 2005
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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