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AzTrials

Multiple SclerosisPhase 2/3NCT00270816

Interferon ß-1b Treatment by Cyclical Administration

A Phase 2/3 study testing Interferon-ß-1b and Interferon ß-1b in people with Multiple Sclerosis, run by S. Andrea Hospital at 1 site in 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

The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. The 8 MUI dose at alternate days is kept constant for years. About 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Interferon-ß-1b and Interferon ß-1b
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
Nov 2005to Jan 2011
Phase
Phase 2/3
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients affected by remitting Multiple Sclerosis who had at least a relapse in the last year of the disease.
  • Satisfying general clinical conditions according to the researcher. Adequate hepatic function. Capacity to use adequate contraceptive techniques during the study.

Who cannot join

  • Any other disease that might better explain signs and symptoms of the patient.
  • Any other disability condition that might interfere with the clinical evolution.
  • History of hypersensitivity to natural or recombinant interferon or to human albumin.
  • Clinically significant heart diseases and not controlled like dysrhythmias, angina pectoris or congestive heart failure.
  • Not adequately controlled epilepsy.
  • Inability, according to the examining commission, to grant a complete compliance with the protocol requirements for the whole study.
Show all 9Show fewer
  • Previous therapies modifying the disease course in the last six months.
  • Steroid therapies in the last 3 months.
  • Pregnancy, lactation, serological positivity to the pregnancy test during the screening period.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"

    Rome, 00139

Other trials in Italy

About this study

Official title: Effect of Cyclical Administration of Interferon β-1b in Multiple Sclerosis - Comparison With Normal Dose.

The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis with positive effects on the disease course. The 8 MUI dose at alternate days is kept constant for years. About 1/3 of patients suspend treatment by three years due to side effects or suspected or accepted ineffectiveness. The main objective of the study is to verify the safety and effectiveness of a cyclical administration (a month of suspension after two of treatment) from the beginning of treatment. There is the possibility that a scheme envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising the drug therapeutic effect) compared to the standard administration protocol. This might also result in an increase of the drug effectiveness and/or in a longer duration of effectiveness itself. Finally, cyclical administration allows patients to spend actual periods of "therapeutic vacation", with positive psychological effects.

Being tested
Interferon-ß-1b, Interferon ß-1b
Keywords
Multiple Sclerosis, Interferon-ß-1b, Therapy
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-ß-1bDrug

    250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months

  • Interferon ß-1bDrug

    250 micrograms (8 MIU) administered subcutaneously (sc) every other day

Study groups in NCT00270816
Study groupRoleWhat they receive
interferon beta cyclical administrationExperimentalInterferon ß-1b Treatment by Cyclical Administration
Receives: Drug: Interferon-ß-1b
Interferon ß-1b TreatmentActive comparatorInterferon ß-1b Treatment
Receives: Drug: Interferon ß-1b

What is being measured

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

  1. number of gad-enhancing lesions (CELs) in T1

    Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs

    Measured: baseline and after 12 months

Secondary outcomes (3)

  1. number of new and enlarging T2 lesions

    Group (cyclic withdrawal vs full regimen) differences in new and enlarging T2 lesions

    Measured: baseline and after 12 months

  2. volume of T1 lesions (black holes)

    Group (cyclic withdrawal vs full regimen) differences in T1 lesion volume (black holes)

    Measured: baseline and after 12 months

  3. relapse rate

    Group (cyclic withdrawal vs full regimen) differences in relapse rate

    Measured: baseline and after 12 months

Timeline

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

  1. First posted28 Dec 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionAug 2010
  4. Study completionJan 2011

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00270816
Sponsor's protocol ID
NEU - CYC - 06
Status last verified
Dec 2018
First submitted
27 Dec 2005
Last updated
19 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Steinman L. Immunotherapy of multiple sclerosis: the end of the beginning. Curr Opin Immunol. 2001 Oct;13(5):597-600. doi: 10.1016/s0952-7915(00)00266-1.

    PubMed 11544011

  • Calabresi PA, Stone LA, Bash CN, Frank JA, McFarland HF. Interferon beta results in immediate reduction of contrast-enhanced MRI lesions in multiple sclerosis patients followed by weekly MRI. Neurology. 1997 May;48(5):1446-8. doi: 10.1212/wnl.48.5.1446.

    PubMed 9153489

  • Richert ND, Zierak MC, Bash CN, Lewis BK, McFarland HF, Frank JA. MRI and clinical activity in MS patients after terminating treatment with interferon beta-1b. Mult Scler. 2000 Apr;6(2):86-90. doi: 10.1177/135245850000600206.

    PubMed 10773853

  • Langenkamp A, Messi M, Lanzavecchia A, Sallusto F. Kinetics of dendritic cell activation: impact on priming of TH1, TH2 and nonpolarized T cells. Nat Immunol. 2000 Oct;1(4):311-6. doi: 10.1038/79758.

    PubMed 11017102

  • Rissoan MC, Soumelis V, Kadowaki N, Grouard G, Briere F, de Waal Malefyt R, Liu YJ. Reciprocal control of T helper cell and dendritic cell differentiation. Science. 1999 Feb 19;283(5405):1183-6. doi: 10.1126/science.283.5405.1183.

    PubMed 10024247

  • Skok J, Poudrier J, Gray D. Dendritic cell-derived IL-12 promotes B cell induction of Th2 differentiation: a feedback regulation of Th1 development. J Immunol. 1999 Oct 15;163(8):4284-91.

    PubMed 10510367

  • McDonald WI, Compston A, Edan G, Goodkin D, Hartung HP, Lublin FD, McFarland HF, Paty DW, Polman CH, Reingold SC, Sandberg-Wollheim M, Sibley W, Thompson A, van den Noort S, Weinshenker BY, Wolinsky JS. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001 Jul;50(1):121-7. doi: 10.1002/ana.1032.

    PubMed 11456302

  • Pozzilli C, Bastianello S, Koudriavtseva T, Gasperini C, Bozzao A, Millefiorini E, Galgani S, Buttinelli C, Perciaccante G, Piazza G, Bozzao L, Fieschi C. Magnetic resonance imaging changes with recombinant human interferon-beta-1a: a short term study in relapsing-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry. 1996 Sep;61(3):251-8. doi: 10.1136/jnnp.61.3.251.

    PubMed 8795595

  • Romano S, Ferraldeschi M, Bagnato F, Mechelli R, Morena E, Caldano M, Buscarinu MC, Fornasiero A, Frontoni M, Nociti V, Mirabella M, Mayer F, Bertolotto A, Pozzilli C, Vanacore N, Salvetti M, Ristori G. Drug Holiday of Interferon Beta 1b in Multiple Sclerosis: A Pilot, Randomized, Single Blind Study of Non-inferiority. Front Neurol. 2019 Jul 16;10:695. doi: 10.3389/fneur.2019.00695. eCollection 2019.

    PubMed 31379701

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Interferon-ß-1b and Interferon ß-1b in people with Multiple Sclerosis, run by S. Andrea Hospital at 1 site in 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 2 inclusion and 9 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

number of gad-enhancing lesions (CELs) in T1 (time frame: baseline and after 12 months). 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 NCT00270816, which also lists 9 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 19 Dec 2018.

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