Interferon ß-1b Treatment by Cyclical Administration
17. december 2018 opdateret af: Giovanni Ristori, S. Andrea Hospital
Effect of Cyclical Administration of Interferon β-1b in Multiple Sclerosis - Comparison With Normal Dose.
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rome, Italien, 00139
- Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: interferon beta cyclical administration
Interferon ß-1b Treatment by Cyclical Administration
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250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months
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Aktiv komparator: Interferon ß-1b Treatment
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250 micrograms (8 MIU) administered subcutaneously (sc) every other day
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
number of gad-enhancing lesions (CELs) in T1
Tidsramme: baseline and after 12 months
|
Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs
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baseline and after 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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number of new and enlarging T2 lesions
Tidsramme: baseline and after 12 months
|
Group (cyclic withdrawal vs full regimen) differences in new and enlarging T2 lesions
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baseline and after 12 months
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volume of T1 lesions (black holes)
Tidsramme: baseline and after 12 months
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Group (cyclic withdrawal vs full regimen) differences in T1 lesion volume (black holes)
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baseline and after 12 months
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relapse rate
Tidsramme: baseline and after 12 months
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Group (cyclic withdrawal vs full regimen) differences in relapse rate
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baseline and after 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Marco Salvetti, MD, S.Andrea Hospital, University of Rome "La Sapienza"
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2005
Primær færdiggørelse (Faktiske)
1. august 2010
Studieafslutning (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først indsendt
27. december 2005
Først indsendt, der opfyldte QC-kriterier
27. december 2005
Først opslået (Skøn)
28. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NEU - CYC - 06
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .