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Interferon ß-1b Treatment by Cyclical Administration

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 28, 2005
Last Update Posted: February 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Italian Multiple Sclerosis Foundation
Information provided by:
S. Andrea Hospital
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
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.

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 ]
  • number of gad-enhancing lesions in T1 [ Time Frame: baseline and after 12 months ]

Secondary Outcome Measures:
  • relapse rate [ Time Frame: baseline and after 12 months ]
  • volume of T1 lesions (black holes) [ Time Frame: baseline and after 12 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270816

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

Additional Information:
Steinman L. Immunotherapy of multiple sclerosis: the end of the beginning. Curr Opin Immunol. 2001 Oct;13(5):597-600. Review.
Calabresi PA, Stone LA, Bash CN, Frank JA, McFarland HF. Interferon beta results in immediate reduction of contrast-enhanced MRI lesions in multiple sclerosis patients followed by weekly MRI. Neurology. 1997 May;48(5):1446-8.
Richert ND, Zierak MC, Bash CN, Lewis BK, McFarland HF, Frank JA. MRI and clinical activity in MS patients after terminating treatment with interferon beta-1b. Mult Scler. 2000 Apr;6(2):86-90.
Langenkamp A, Messi M, Lanzavecchia A, Sallusto F. Kinetics of dendritic cell activation: impact on priming of TH1, TH2 and nonpolarized T cells. Nat Immunol. 2000 Oct;1(4):311-6.
Rissoan MC, Soumelis V, Kadowaki N, Grouard G, Briere F, de Waal Malefyt R, Liu YJ. Reciprocal control of T helper cell and dendritic cell differentiation. Science. 1999 Feb 19;283(5405):1183-6.
Skok J, Poudrier J, Gray D. Dendritic cell-derived IL-12 promotes B cell induction of Th2 differentiation: a feedback regulation of Th1 development. J Immunol. 1999 Oct 15;163(8):4284-91.
McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin FD, McFarland HF, Paty DW, Polman CH, Reingold SC, Sandberg-Wollheim M, Sibley W, Thompson A, van den Noort S, Weinshenker BY, Wolinsky JS. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001 Jul;50(1):121-7.
Pozzilli C, Bastianello S, Koudriavtseva T, Gasperini C, Bozzao A, Millefiorini E, Galgani S, Buttinelli C, Perciaccante G, Piazza G, Bozzao L, Fieschi C. Magnetic resonance imaging changes with recombinant human interferon-beta-1a: a short term study in relapsing-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry. 1996 Sep;61(3):251-8.

Responsible Party: Marco Salvetti, CENTERS
ClinicalTrials.gov Identifier: NCT00270816     History of Changes
Other Study ID Numbers: NEU - CYC - 06
First Submitted: December 27, 2005
First Posted: December 28, 2005
Last Update Posted: February 11, 2014
Last Verified: December 2013

Keywords provided by S. Andrea Hospital:
Multiple Sclerosis

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

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