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Optimizing IFN Beta - 1B Dose

NCT ID: NCT00473213

Last Updated: 2007-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2004-02-29

Brief Summary

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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).

Detailed Description

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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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Interferon Beta 1

Intervention Type DRUG

Eligibility Criteria

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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:
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dimensione Ricerca s.r.l.

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role lead

Principal Investigators

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Luca Durelli, Prophessor

Role: STUDY_CHAIR

Università degli studi di Torino-Clinica Neurologica I , Via Cherasco 15 10100 Torino

Antonio Carolei, M D

Role: PRINCIPAL_INVESTIGATOR

Ospedale Nuovo San Salvatore-Clinica Neurologica .Località Coppito.67100 L'Aquila

Roberto Cavallo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Mafggiore San Giovanni Bosco,Divisione di Neurologia Piazza Donatori del Sangue, 3 10154 Torino

Vittorio Cosi, Prophessor

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Parma .Dipartimento di Scienze Neurologiche.Via Palestro 3 27100 Pavia

Luciano Deotto, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile Maggiore, Divisione Neurologica, Piazzale Stefani1 37134 Verona

Claudio Geda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile di Chivasso.Divisione di Neurologia10034 Chivasso Torino

Giorgio gIULIANI, M.D

Role: PRINCIPAL_INVESTIGATOR

Ospedale Generale di Macerata,Servizio di Neurofisiopatologia, Via Santa Lucia 1 62100 Macerata.

Angelo Ghezzi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale SAntonio Abate Servizio recupero Neurologico. Centro Studi S.M. Via Pastore 4 21013 Gallarate (VA)

Roberto Cotrufo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Policlinico II Università degli Studi di Napoli. Dipartimento di Neurologia.Piazza Miraglia 2 80138 Napoli

Luigi Murri, Prophessor

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Pisa Clinica Neurologica, Via Roma 67 56100 Pisa

Domenico Caputo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istituto Don Carlo Gnocchi Divisione Neurologica Riabilitativa. Via Capecelatro 66 20148 Milano

Enrico Montanari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile di Fidenza, Divisione di Neurologia Via Borghesi 1, 43036 Fidenza (Pr)

Franco Perla, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale S. Croce e Carle Divisione di Neurologia, Via Michele Coppino 26, 12100 Cuneo

Federico Piccoli, Prophessor

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Palermo Istituto di Neuropsichiatria, Via Gaetano della Loggia 90129 Palermo

Alessandra Protti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Niguarda Cà Granda Divisione Neurologica, Piazza Benefattori 3, 20100 Milano

Giovanni Meola, Prophessor

Role: PRINCIPAL_INVESTIGATOR

Ospedale Clinico San Donato Neurologia, Via Morandi 30, 20097 San Donato Milanese

Arturo Reggio, Prophessor

Role: PRINCIPAL_INVESTIGATOR

Policlinico Universitario Centro Sclerosi Multipla, Via S.Sofia 78, 95185 Catania

MariaRosa Rottoli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedali Riuniti di Bergamo Divisione di Neurologia.Largo Barozzi.124100 Bergamo

Elio Scarpini, M.D

Role: PRINCIPAL_INVESTIGATOR

Università Degli Studi di Milano Istituto di Clinica Neurologica .Via Francesco Sforza 35 20122 Milano

Andrea Spissu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera G. Brotzu Divisione di Neurologia. Via G. Peretti 90134 Cagliari

Francesco Teatini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ospedale Generale di Bolzano Divisione di Neurologia Via Lorenz Bohler 5 39100 Bolzano

Riccardo Urciuoli, M.D-

Role: PRINCIPAL_INVESTIGATOR

Ospedale Silvestrini Divisione di Neurologia 06156 Loc S Andrea delle Fratte Perugia

Luisa Motti, M.D

Role: PRINCIPAL_INVESTIGATOR

Centro Sclerosi Multipla Divisione di Neurologia Arcispedale S.Maria Nuova, Viale Risorgimento 57 42100 Reggio Emilia

Ruggero Capra, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centro Regionale Sclerosi Multipla Piazzale Spitali Civili 1 25123 Brescia

References

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Durelli L, Bongioanni MR, Ferrero B, Oggero A, Marzano A, Rizzetto M. Interferon treatment for multiple sclerosis: autoimmune complications may be lethal. Neurology. 1998 Feb;50(2):570-1. doi: 10.1212/wnl.50.2.570. No abstract available.

Reference Type BACKGROUND
PMID: 9484407 (View on PubMed)

Durelli L, Barbero P, Cucci A, Ferrero B, Ricci A, Contessa G, De Mercanti S, Ripellino P, Lapuma D, Viglietta E, Bergui M, Versino E, Clerico M; OPTIMS Trial NAb Sub-Study Group. Neutralizing antibodies in multiple sclerosis patients treated with 375 micrograms interferon-beta-1b. Expert Opin Biol Ther. 2009 Apr;9(4):387-97. doi: 10.1517/14712590902762781.

Reference Type DERIVED
PMID: 19278300 (View on PubMed)

Other Identifiers

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IFN1B/99

Identifier Type: -

Identifier Source: org_study_id