Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Italian Multiple Sclerosis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interferon beta cyclical administration | Experimental | Interferon ß-1b Treatment by Cyclical Administration |
|
| Interferon ß-1b Treatment | Active Comparator | Interferon ß-1b Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-ß-1b | Drug | 250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| number of new and enlarging T2 lesions | Group (cyclic withdrawal vs full regimen) differences in new and enlarging T2 lesions | baseline and after 12 months |
| volume of T1 lesions (black holes) | Group (cyclic withdrawal vs full regimen) differences in T1 lesion volume (black holes) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marco Salvetti, MD | S.Andrea Hospital, University of Rome "La Sapienza" | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza" | Rome | 00139 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11544011 | Background | 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. | |
| 9153489 | 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. |
| Label | URL |
|---|---|
| SPONSOR SITE | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Interferon ß-1b | Drug | 250 micrograms (8 MIU) administered subcutaneously (sc) every other day |
|
| baseline and after 12 months |
| relapse rate | Group (cyclic withdrawal vs full regimen) differences in relapse rate | baseline and after 12 months |
| 10773853 | 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. |
| 11017102 | 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. |
| 10024247 | 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. |
| 10510367 | 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. |
| 11456302 | 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. |
| 8795595 | 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. |
| 31379701 | Derived | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |