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Interferon ß-1b Treatment by Cyclical Administration

NCT ID: NCT00270816

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Keywords

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Multiple Sclerosis Interferon-ß-1b Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interferon beta cyclical administration

Interferon ß-1b Treatment by Cyclical Administration

Group Type EXPERIMENTAL

Interferon-ß-1b

Intervention Type DRUG

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

Interferon ß-1b Treatment

Interferon ß-1b Treatment

Group Type ACTIVE_COMPARATOR

Interferon ß-1b

Intervention Type DRUG

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

Interventions

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Interferon-ß-1b

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

Intervention Type DRUG

Interferon ß-1b

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Multiple Sclerosis Foundation

OTHER

Sponsor Role collaborator

S. Andrea Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Ristori

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Salvetti, MD

Role: STUDY_DIRECTOR

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

Locations

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

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 11544011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9153489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10773853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11017102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10024247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10510367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11456302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8795595 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31379701 (View on PubMed)

Related Links

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http://www.ospedalesantandrea.it

SPONSOR SITE

Other Identifiers

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NEU - CYC - 06

Identifier Type: -

Identifier Source: org_study_id