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Sponsors and Collaborators: |
University of Turin, Italy Dimensione Ricerca s.r.l. |
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Information provided by: | University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT00473213 |
BetaferonR is effective in reducing relapse rate and MRI T2-weighted lesion frequency in MS patients at the dose of 8 MIU on alternate days (THE IFNB MS Study Group, 1993). Relapse rate is reduced by 30-35% (The IFNB MS Study Group, 1993), MRI activity is decreased up to 100% in most cases (Stone et al 1995). In some patients, however, MRI activity still occurs or reappears during treatment (Stone et al 1995). MRI activity has been demonstrated to correlate with relapse occurrence (McFarland et al, 1992; Miller et al, 1996), and in some patients relapses still occur during IFN beta treatment. In other patients relapses may occur in association with the appearance, after 9-18 months of treatment, of anti-IFN beta NAB (The IFNB M S Study Group, 1995). This protocol hypothesizes that the dose of 12 MIU BetaferonR on alternate days has more pronounced MRI and clinical effects in MS patients than that of 8 MIU. MS patients who do not respond to 8 MIU may take advantage of a higher dose. We, therefore decided to assess MRI effects after increasing the Betaferon dose (12 MIU) in RRMS patients showing a residual MRI activity (at least one new Gd enhancing lesion) during six months of standard Betaferon dose treatment (8 MIU).
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: Interferon Beta 1 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Optimizing IFN Beta - 1B Dose |
Enrollment: | 217 |
Study Start Date: | September 1999 |
Study Completion Date: | February 2004 |
Comparing the frequency of new Gd enhancing lesions in a group of patients presenting a residual MRI activity during the last four months of the six month standard dose (8MIU) Betaferon treatment randomized to continue the standard dose or to increase the dose to 12 MIU Betaferon
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Luca Durelli, Prophessor | Università degli studi di Torino-Clinica Neurologica I , Via Cherasco 15 10100 Torino |
Principal Investigator: | Antonio Carolei, M D | Ospedale Nuovo San Salvatore-Clinica Neurologica .Località Coppito.67100 L'Aquila |
Principal Investigator: | Roberto Cavallo, M.D. | Ospedale Mafggiore San Giovanni Bosco,Divisione di Neurologia Piazza Donatori del Sangue, 3 10154 Torino |
Principal Investigator: | Vittorio Cosi, Prophessor | Università degli Studi di Parma .Dipartimento di Scienze Neurologiche.Via Palestro 3 27100 Pavia |
Principal Investigator: | Luciano Deotto, M.D. | Ospedale Civile Maggiore, Divisione Neurologica, Piazzale Stefani1 37134 Verona |
Principal Investigator: | Claudio Geda, M.D. | Ospedale Civile di Chivasso.Divisione di Neurologia10034 Chivasso Torino |
Principal Investigator: | Giorgio gIULIANI, M.D | Ospedale Generale di Macerata,Servizio di Neurofisiopatologia, Via Santa Lucia 1 62100 Macerata. |
Principal Investigator: | Angelo Ghezzi, M.D. | Ospedale SAntonio Abate Servizio recupero Neurologico. Centro Studi S.M. Via Pastore 4 21013 Gallarate (VA) |
Principal Investigator: | Roberto Cotrufo, M.D. | Policlinico II Università degli Studi di Napoli. Dipartimento di Neurologia.Piazza Miraglia 2 80138 Napoli |
Principal Investigator: | Luigi Murri, Prophessor | Università degli Studi di Pisa Clinica Neurologica, Via Roma 67 56100 Pisa |
Principal Investigator: | Domenico Caputo, M.D. | Istituto Don Carlo Gnocchi Divisione Neurologica Riabilitativa. Via Capecelatro 66 20148 Milano |
Principal Investigator: | Enrico Montanari, M.D. | Ospedale Civile di Fidenza, Divisione di Neurologia Via Borghesi 1, 43036 Fidenza (Pr) |
Principal Investigator: | Franco Perla, M.D. | Ospedale S. Croce e Carle Divisione di Neurologia, Via Michele Coppino 26, 12100 Cuneo |
Principal Investigator: | Federico Piccoli, Prophessor | Università degli Studi di Palermo Istituto di Neuropsichiatria, Via Gaetano della Loggia 90129 Palermo |
Principal Investigator: | Alessandra Protti, M.D. | Ospedale Niguarda Cà Granda Divisione Neurologica, Piazza Benefattori 3, 20100 Milano |
Principal Investigator: | Giovanni Meola, Prophessor | Ospedale Clinico San Donato Neurologia, Via Morandi 30, 20097 San Donato Milanese |
Principal Investigator: | Arturo Reggio, Prophessor | Policlinico Universitario Centro Sclerosi Multipla, Via S.Sofia 78, 95185 Catania |
Principal Investigator: | MariaRosa Rottoli, M.D. | Ospedali Riuniti di Bergamo Divisione di Neurologia.Largo Barozzi.124100 Bergamo |
Principal Investigator: | Elio Scarpini, M.D | Università Degli Studi di Milano Istituto di Clinica Neurologica .Via Francesco Sforza 35 20122 Milano |
Principal Investigator: | Andrea Spissu, M.D. | Azienda Ospedaliera G. Brotzu Divisione di Neurologia. Via G. Peretti 90134 Cagliari |
Principal Investigator: | Francesco Teatini, M.D. | Ospedale Generale di Bolzano Divisione di Neurologia Via Lorenz Bohler 5 39100 Bolzano |
Principal Investigator: | Riccardo Urciuoli, M.D- | Ospedale Silvestrini Divisione di Neurologia 06156 Loc S Andrea delle Fratte Perugia |
Principal Investigator: | Luisa Motti, M.D | Centro Sclerosi Multipla Divisione di Neurologia Arcispedale S.Maria Nuova, Viale Risorgimento 57 42100 Reggio Emilia |
Principal Investigator: | Ruggero Capra, M.D. | Centro Regionale Sclerosi Multipla Piazzale Spitali Civili 1 25123 Brescia |
Study ID Numbers: | IFN1B/99 |
Study First Received: | May 11, 2007 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00473213 History of Changes |
Health Authority: | Italy: Ministry of Health; Italy: The Italian Medicines Agency |
Multiple Sclerosis Interferon Magnetic Resonance |
Autoimmune Diseases Multiple Sclerosis Immunologic Factors Demyelinating Diseases Interferons |
Interferon-beta Demyelinating Autoimmune Diseases, CNS Sclerosis Antiviral Agents Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Interferons |
Interferon-beta Sclerosis Antiviral Agents Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |