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Interferon ß-1b Treatment by Cyclical Administration

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Interferon-ß-1b

Interferon ß-1b

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Interferon-ß-1b, Therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

interferon beta cyclical administration

Interferon ß-1b Treatment

Arm Description

Interferon ß-1b Treatment by Cyclical Administration

Interferon ß-1b Treatment

Outcomes

Primary Outcome Measures

number of gad-enhancing lesions (CELs) in T1

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

Secondary Outcome Measures

number of new and enlarging T2 lesions

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

volume of T1 lesions (black holes)

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

relapse rate

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

Full Information

NCT ID

NCT00270816

First Posted

December 27, 2005

Last Updated

December 17, 2018

Sponsor

S. Andrea Hospital

Collaborators

Italian Multiple Sclerosis Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00270816

Brief Title

Interferon ß-1b Treatment by Cyclical Administration

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

November 2005 (Actual)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

S. Andrea Hospital

Collaborators

Italian Multiple Sclerosis Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis, Interferon-ß-1b, Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

interferon beta cyclical administration

Arm Type

Experimental

Arm Description

Interferon ß-1b Treatment by Cyclical Administration

Arm Title

Interferon ß-1b Treatment

Arm Type

Active Comparator

Arm Description

Interferon ß-1b Treatment

Intervention Type

Drug

Intervention Name(s)

Interferon-ß-1b

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Interferon ß-1b

Intervention Description

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

Primary Outcome Measure Information:

Title

number of gad-enhancing lesions (CELs) in T1

Description

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

Time Frame

baseline and after 12 months

Secondary Outcome Measure Information:

Title

number of new and enlarging T2 lesions

Description

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

Time Frame

baseline and after 12 months

Title

volume of T1 lesions (black holes)

Description

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

Time Frame

baseline and after 12 months

Title

relapse rate

Description

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

Time Frame

baseline and after 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco Salvetti, MD

Organizational Affiliation

S.Andrea Hospital, University of Rome "La Sapienza"

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Rome

ZIP/Postal Code

00139

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

11544011

Citation

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.

Results Reference

background

PubMed Identifier

9153489

Citation

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.

Results Reference

background

PubMed Identifier

10773853

Citation

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.

Results Reference

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PubMed Identifier

11017102

Citation

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.

Results Reference

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PubMed Identifier

10024247

Citation

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.

Results Reference

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PubMed Identifier

10510367

Citation

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.

Results Reference

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PubMed Identifier

11456302

Citation

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.

Results Reference

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PubMed Identifier

8795595

Citation

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.

Results Reference

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PubMed Identifier

31379701

Citation

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.

Results Reference

derived

Links:

URL

http://www.ospedalesantandrea.it

Description

SPONSOR SITE

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Interferon ß-1b Treatment by Cyclical Administration

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