Optimizing IFN Beta - 1B Dose (Optims)

This study has been completed.
Sponsor:
Collaborator:
Dimensione Ricerca s.r.l.
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00473213
First received: May 11, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Optimizing IFN Beta - 1B Dose

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • the effects of BetaferonR on MRI enhancing lesion frequency are detectable very early.Differently from clinical effects on relapse rate, BetaferonR administration results in an almost immediate reduction of enhancing lesion frequency at MRI. [ Time Frame: two year ]

Secondary Outcome Measures:
  • Monitoring MRI effects (evaluating the number of total active lesions, areas of gadolinium-enhancing, T1 hypointense, and T2 hyperintense lesions)Monitoring clinical effects (relapse frequency and severity, changes in EDSS) [ Time Frame: two years ]

Enrollment: 217
Study Start Date: September 1999
Study Completion Date: February 2004
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained.
  2. Age between 18 and 50 years inclusive.
  3. Male and female patients.
  4. Clinically definite or laboratory supported definite RR MS (Poser et al, 1983) for not less than 2 year.
  5. Two clinically documented relapses during the preceding 24 months.
  6. No relapse or relapse related neurological deterioration for at least 30 days prior to entry in the study.
  7. Patients EDSS score from 1 to 3.5 (probably to be extended to 5.5).
  8. MRI activity. At least one enhancing lesion during the baseline MRI run-in study .
  9. Women capable of having children must agree to use adequate con-traceptive methods (condoms with spermicides, IUCD, oral contraceptives or other adequate barrier contraception).
  10. Caregivers agreement to assist the patient to comply with study requirements, if neces-sary (e.g. study drug administration, visits to center).

Exclusion Criteria:

  1. Any form of Multiple Sclerosis other than relapsing-remitting.
  2. Any other disease which could better explain the patient's signs and symptoms.
  3. Any other disabling condition, which could interfere with the clinical evaluation.
  4. Pregnancy or lactation.
  5. Medical psychiatric, or other conditions that compromise patient's ability to give informed consent, to comply with the trial protocol, or to complete the study.
  6. Alcohol or drug abuse in the 90 days preceding screening visit.
  7. Uncontrolled clinically significant heart diseases, i.e., cardiac arrhythmias, uncon-trolled angina pectoris, uncompensated congestive heart failure
  8. Clinically significant liver, renal and bone marrow dysfunction as defined by the ran-ges of laboratory evaluations. The following ranges (see table 1) for key laboratory evaluations will be considered as adequate for inclusion:
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473213

Sponsors and Collaborators
University of Turin, Italy
Dimensione Ricerca s.r.l.
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00473213     History of Changes
Other Study ID Numbers: IFN1B/99
Study First Received: May 11, 2007
Last Updated: May 11, 2007
Health Authority: Italy: Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by University of Turin, Italy:
Multiple Sclerosis
Interferon
Magnetic Resonance

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon-beta
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014