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

Recombinant IFN alpha-2b for relapsing –remitting multiple sclerosis. Phase III, randomized, double blind, placebo-controlled clinical trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000073

Enrollment

159

Registered

2009-02-11

Start date

1995-05-13

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting multiple sclerosis, clinically defined according to Poser criteria (Ann Neurol 1983

Interventions

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, t

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Cuba

Contacts

Public ContactGiselle Rol

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

giselle.penton@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026