Interferon ß-1b Treatment by Cyclical Administration

NCT00270816 | Completed Phase 2 DMC

• 1 other identifier: NEU - CYC - 06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Interferon-ß-1b; Therapy

Outcome Measures

Primary Outcomes (1)

• number of gad-enhancing lesions (CELs) in T1

  Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs

  baseline and after 12 months

Secondary Outcomes (3)

• number of new and enlarging T2 lesions

  baseline and after 12 months

• volume of T1 lesions (black holes)

  baseline and after 12 months

• relapse rate

  baseline and after 12 months

Study Arms (2)

interferon beta cyclical administration

EXPERIMENTAL

Interferon ß-1b Treatment by Cyclical Administration

Drug: Interferon-ß-1b

Interferon ß-1b Treatment

ACTIVE COMPARATOR

Interferon ß-1b Treatment

Drug: Interferon ß-1b

Interventions

Interferon-ß-1b DRUG

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

interferon beta cyclical administration

Interferon ß-1b DRUG

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

Interferon ß-1b Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S. Andrea Hospital: lead
• Italian Multiple Sclerosis Foundation: collaborator

Study Sites (1)

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

Rome, 00139, Italy

Location

Related Publications (9)

• Steinman L. Immunotherapy of multiple sclerosis: the end of the beginning. Curr Opin Immunol. 2001 Oct;13(5):597-600. doi: 10.1016/s0952-7915(00)00266-1.

  PMID: 11544011 BACKGROUND

• 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. doi: 10.1212/wnl.48.5.1446.

  PMID: 9153489 BACKGROUND

• 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. doi: 10.1177/135245850000600206.

  PMID: 10773853 BACKGROUND

• 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. doi: 10.1038/79758.

  PMID: 11017102 BACKGROUND

• 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. doi: 10.1126/science.283.5405.1183.

  PMID: 10024247 BACKGROUND

• 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.

  PMID: 10510367 BACKGROUND

• 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. doi: 10.1002/ana.1032.

  PMID: 11456302 BACKGROUND

• 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. doi: 10.1136/jnnp.61.3.251.

  PMID: 8795595 BACKGROUND

• Romano S, Ferraldeschi M, Bagnato F, Mechelli R, Morena E, Caldano M, Buscarinu MC, Fornasiero A, Frontoni M, Nociti V, Mirabella M, Mayer F, Bertolotto A, Pozzilli C, Vanacore N, Salvetti M, Ristori G. Drug Holiday of Interferon Beta 1b in Multiple Sclerosis: A Pilot, Randomized, Single Blind Study of Non-inferiority. Front Neurol. 2019 Jul 16;10:695. doi: 10.3389/fneur.2019.00695. eCollection 2019.

  PMID: 31379701 DERIVED

Related Links

• SPONSOR SITE

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marco Salvetti, MD

  S.Andrea Hospital, University of Rome "La Sapienza"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 27, 2005
• First Posted: December 28, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

IT (1)