Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis.

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000073
• Date of registration: 11/02/2009
• Primary sponsor: Center for Genetic Engineering and Biotechnology, La Habana.
• Public title: Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis.
• Scientific title: Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis. Phase III, randomized, double blind, placebo-controlled clinical trial.
• Date of first enrolment: 13/05/1995
• Target sample size: 159
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000073-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Giselle Rol
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

• Name: Giselle Rol
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Key inclusion & exclusion criteria

Inclusion criteria: 1.Diagnosis of relapsing remitting multiple sclerosis defined according to Poser criteria. 2.Clinically stable patients for at least 30 days without having received any treatment with steroids during this time. 3.Duration of the disease of two years having 2 relapses at least. 4.Score of 6.5 or less in the Kurtzke EDSS scale. 5.18 to 50 years of age. 6.Patient willingness through informed consent signature.
Exclusion criteria: 1.Being in the acute phase of the disease. 2.Progressive clinical form. 3.Presence of any disease explaining the clinical symptoms or unfavorable outcome having a defined therapeutic behavior. 4.Pregnancy or puerpery. 5.Women in fertile age during contraceptive hormonal therapy. 6.Having received treatment with aziathroprina or Cyclofosfamide during the last year. 7.Uncontrolled chronic disease (heart, liver or kidney failure). 8.IFN hypersensitivity background.

Age minimum: 18 years
Age maximum: 50 years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-remitting multiple sclerosis, clinically defined according to Poser criteria (Ann Neurol 1983; 13: 227-231).

Intervention(s)

Group I: Recombinant IFN alpha-2b, 10 x 106 UI by intramuscular route, twice a week separated by 3 days at least for two years. Group II: Recombinant IFN alpha-2b, 3 x 106 UI by intramuscular route, twice a week separated by 3 days at least for two years. Group III: Placebo by intramuscular route, twice a week separated by 3 days at least for two years.

Primary Outcome(s)

The mean number of relapses per patient in each group during the two years of treatment.

Secondary Outcome(s)

1.Proportion of patients without relapses during the two years of treatment. 2.Variation in the Scripps-NRS scale at the beginning, annually and during relapses. 3.Variations in the degree of disability according to the Kurtzke EDSS at the beginning and annually. 4.Magnetic Resonance Imaging at the beginning and annually in a group of cases. 5.Evaluation of the cognitive function in a group of patients. 6.Treatment safety (occurrence of adverse events).

Secondary ID(s)

IG/IAI/EM/9501.

Source(s) of Monetary Support

Heber Biotec S.A. and Cuban Ministry of Public Health.