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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

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

Secondary indentifying numbers:

IG/IAI/EM/9501.

Issuing authority of the secondary identifying numbers:

CIGB

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

23/03/1995

Reference number:

ERM:176/95

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

José A. Cabrera Gómez (Current affiliation: International Center of Neurological Restoration, La Habana).

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Cienfuegos, “Dr Gustavo Aldereguía” Provincial Hospital, Nancy Echazábal Santana. Camaguey, “Manuel Ascunce Domenech” University Hospital, Orestes Herrera Lorenzo, Rosbel Morgado Castañeda, Cristina Rivero García. Santiago de Cuba, “Saturnino Lora” Provincial Hospital, Osvaldo Aguilera Pacheco, Idoris Núñez Lahera, Belkis Colina. Granma, “Carlos Manuel de Céspedes” Provincial Hospital, Mabel Oduardo Aguilar, Angel Batista Iturriaga. Matanzas, “José López Tabares” Provincial Hospital, José Miguel Planells Roque Guantánamo, “Agostino Neto” Provincial Hospital, Omar Pozo Amelo, Victor Manuel Rivas Gómez. Pinar del Río, “Abel Santamaría” Provincial Hospital, Antonio García Medina, Ismael Hernández Pérez. Holguín, Clinical-Surgical Hospital, Graciela Laurencio Brunet. Holguín, “Vladimir Ilich Lenin” Hospital, Ruben Ledea Glez, Reynaldo García Escalona. Las Tunas, “Ernesto Guevara” Provincial Hospital, Elder Lorenzo Rosales, Emilio Sao Téllez. Villa Clara, “Arnaldo Milián Castro” Provincial, Hospital Marcos Luis García, Juan Gutiérrez Ronquillo. Villa Clara, Santa Clara Hospital, Luis Crespo Rodríguez. Sancti Spíritus, “Camilo Cienfuegos” Hospital, Javier García Sacarías. Sancti Spíritus, Sancti Spíritus Children Hospital, Ariel Osmany Gómez García. Ciego de Avila, “Antonio Luaces” Provincial Hospital, Rolando Alvarez Llanes, Carlos Casas Díaz. Ciudad de la Habana, “Hermanos Ameijeiras” Hospital, Ramón Beguería Santos, Ilario Chales García, Orlando Valls Pérez. Ciudad de la Habana, Medical-Surgical Research Center (CIMEQ), Hermys Vega, Carlos Ugarte Sánchez, José Jordán González, J E González de la Nuez, J García Lahera, Lic. R Tellez. Ciudad de la Habana, International Center of Neurological Restoration, I Peoso Ibañez, R Rodríguez Roca. Ciudad de la Habana, “Cira García” Hospital, L Quevedo Sotolongo. Ciudad de la Habana, Neurology and Neurosurgery Institute, Esperanza Barroso García.

Research ethics committees:

ad hoc Research Ethics Committee; October, 24th 1994.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

13/05/1995

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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).

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

50 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

159

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Giselle

Middle Name:

Pentón

Last Name:

Rol

Affiliation:

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

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana City

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2087379, 2085887, 2087421, 2087465.

Email :

giselle.penton@cigb.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Giselle

Middle Name:

Pentón

Last Name:

Rol

Affiliation:

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

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana City

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2087379, 2085887, 2087421, 2087465.

Email :

giselle.penton@cigb.edu.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000073

Date of Registration in Primary Registry:

2009-02-11

Record Verification Date:

2009-01-12 19:00

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

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

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