Interferon ß-1b Treatment by Cyclical Administration

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270816
• Other study ID #: NEU - CYC - 06
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2005
• Est. completion date: January 2011

Study information

• Verified date: December 2018
• Source: S. Andrea Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon-ß-1b
250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months
• Interferon ß-1b
250 micrograms (8 MIU) administered subcutaneously (sc) every other day

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"	Rome

Sponsors (2)

Lead Sponsor	Collaborator
S. Andrea Hospital	Italian Multiple Sclerosis Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Steinman L. Immunotherapy of multiple sclerosis: the end of the beginning. Curr Opin Immunol. 2001 Oct;13(5):597-600. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of gad-enhancing lesions (CELs) in T1	Group (cyclic withdrawal vs full regimen) differences in the cumulative number of CELs	baseline and after 12 months
Secondary	number of new and enlarging T2 lesions	Group (cyclic withdrawal vs full regimen) differences in new and enlarging T2 lesions	baseline and after 12 months
Secondary	volume of T1 lesions (black holes)	Group (cyclic withdrawal vs full regimen) differences in T1 lesion volume (black holes)	baseline and after 12 months
Secondary	relapse rate	Group (cyclic withdrawal vs full regimen) differences in relapse rate	baseline and after 12 months

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