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Multiple SclerosisPhase 3OptimsNCT00473213

Optimizing IFN Beta - 1B Dose

A Phase 3 study testing Interferon Beta 1 in people with Multiple Sclerosis, run by University of Turin, Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Interferon Beta 1
How many people
217 participants
Where
No sites listed yet
Study dates
Sep 1999to Feb 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Any form of Multiple Sclerosis other than relapsing-remitting.
  • Any other disease which could better explain the patient's signs and symptoms.
  • Any other disabling condition, which could interfere with the clinical evaluation.
  • Pregnancy or lactation.
  • 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.
  • Alcohol or drug abuse in the 90 days preceding screening visit.
  • Uncontrolled clinically significant heart diseases, i.e., cardiac arrhythmias, uncon-trolled angina pectoris, uncompensated congestive heart failure
  • 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:

About this study

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).

Read the 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

Being tested
Interferon Beta 1
Keywords
Multiple Sclerosis, Interferon, Magnetic Resonance
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon Beta 1Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: two year

Secondary outcomes (1)

  1. 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)

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2007 (estimated)
  2. Study startSep 1999
  3. Study completionFeb 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00473213
Sponsor's protocol ID
IFN1B/99
Acronym
Optims
Status last verified
May 2007
First submitted
11 May 2007
Last updated
14 May 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9484407

  • 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.

    PubMed 19278300

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon Beta 1 in people with Multiple Sclerosis, run by University of Turin, Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2007. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00473213, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2007.

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Optimizing IFN Beta - 1B Dose (NCT00473213) | AzTrials