Optimizing IFN Beta - 1B Dose (Optims)

May 11, 2007 updated by: University of Turin, Italy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
two year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

May 11, 2007

First Submitted That Met QC Criteria

May 11, 2007

First Posted (Estimate)

May 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 14, 2007

Last Update Submitted That Met QC Criteria

May 11, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFN1B/99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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