ESAR-814 Study

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:

Evaluation of the efficacy and safety of subcutaneous administration of CIGB-814 in combination with methotrexate in patients with rheumatoid arthritis.

Secondary indentifying numbers:

IG/CIGB-814SC/AR/1602

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana Ministry of Public Health, Cuba

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 Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Dinorah

Midle name:

Marisabel

Last name:

Prada Hernandez

Medical Specialty :

Specialist of 2nd degree in Rheumatology

Affiliation:

Clinical Surgical Hospital "10 de Octubre"

Postal address:

Ave 10 of Octubre, No. 130

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78776286

Email address:

dinoprada@infomed.sld.cu

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:

Havana, Center for Surgical Medical Research, Alfredo Hernandez Martinez, 2nd Degree Specialist in Rheumatology

Research ethics committees:

Clinical Surgical Hospital "10 de Octubre", December 12, 2016

Center for Surgical Medical Research, December 12, 2016

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/03/2017

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:

Rheumatoid arthritis with moderate activity

Health condition(s) code:

Arthritis, Rheumatoid

Arthritis

Joint Diseases

Rheumatic Diseases

Musculoskeletal Diseases

Connective Tissue Diseases

Skin and Connective Tissue Diseases

Autoimmune Diseases

Immune System Diseases

Intervention(s):

Group I (control): Placebo + Methotrexate + Prednisone + Folic Acid Group II (experimental): CIGB 814 (0,5 mg) + Methotrexate + Prednisone + Folic Acid Group III (experimental): CIGB 814 (1,0 mg) + Methotrexate + Prednisone + Folic Acid Group IV (experimental): CIGB 814 (2,5 mg) + Methotrexate + Prednisone + Folic Acid The experimental treatment/placebo will receive by subcutaneous route (deltoid region) once a week for the first four weeks, and often the remaining five months of treatment monthly. The Methotrexate (12.5 mg) will receive by subcutaneous route (deltoid region), once a week for the first four weeks, and frequently monthly for the remaining five months of treatment. This subcutaneous injection will be independent of the experimental treatment. The Prednisone (5 mg) will receive 2 tablets daily by oral route for 24 weeks The Folic Acid (5 mg tablet) will receive by oral route once a week for 24 weeks.

Intervention code:

Peptides

Methotrexate

Prednisone

Folic Acid

Injections, Subcutaneous

Administration, Oral

Tablets

Placebos

Intervention keyword:

CIGB-814

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):

ACR clinical response (ACR20, ACR50 or ACR70. ACR20 decrease at least 20% in the number of painful joints and in the number of inflamed joints, and a 20% improvement in 3 of 5 following parameters: 1-Assessment of pain by the patient; 2-Overall evaluation of the patient's disease activity; 3-Overall assessment of disease activity by the physician; 4-Evaluation of the patient's physical function, through a self-assessment instrument; 5-Determination of acute phase reactants (C-reactive protein, erythrocyte sedimentation). ACR50 decrease at least 50% in the number of painful joints and in the number of inflamed joints, and a 50% improvement in 3 of 5 parameters. ACR70 decrease at least 70% in the number of painful joints and in the number of inflamed joints, and a 70% improvement in 3 of 5 parameters). Measurement time: at baseline, Weeks 1, 2, 3, 4 and, Months 2, 3, 4, 5, 6 and 9. EULAR response (Assessment of clinical activity by DAS28. DAS28 <2.6 Referral; DAS28> 2.6 and = 3.2; Light disease activity; DAS28> 3.2 e = 5.2 Moderate disease activity; DAS28> 5.2 Severe disease activity). Measurement time: at baseline, Weeks 1, 2, 3, 4 and, Months 2, 3, 4, 5, 6 and 9.

Key secondary outcomes:

Clinical Adverse Events-AE (Ocurrence of AE (Yes, No), Description of AE (event name), -AE intensity (mild, moderate, severe)). Measurement time: at baseline, in the first four weeks, and in the months 2, 3, 4, 5, 6 and 9 Laboratory test (Numerical values of hemochemical tests: hemoglobin, hematocrit, leukogram with differential, velocity of globular sedimentation and platelet count). Measurement time: at the beginning, in the first four weeks, and in the months 2, 3, 4, 5, 6 and 9. Immunological response: Quantification of inflammatory cytokine levels (IL-17, IFNγ and TNFα). Measurement time: at baseline, months 6 and 9. Determination of C-reactive protein (values of test). Measurement time: at baseline, months 6 and 9. Citrullinated antibodies (values obtained by ELISA in patient sera). Measurement time: at baseline, months 6 and 9. Imaging response: Evaluation of the imaging changes (edema, erosion, synovitis) in the most affected hand of the patients through magnetic resonance imaging. Measurement time: at the beginning and in the months 6 and 9. Quality of life (Questionnaire SF36). Measurement time: at baseline, Weeks 1, 2, 3 and 4, Months 2, 3, 4, 5, 6 and 9. Clinical response according to SDAI (Simplified Disease Activity Index. High activity> 26, Moderate activity> 11.1 and <26, Low activity> 3.3 and <11, Remission <3.3). Measurement time: Weeks 24 and 36. Clinical response according to SDAI (Clinical Disease Activity Index. High Activity> 22, Moderate Activity> 10.0-22, Low Activity> 2.8 -10, Referral 2.8). Measurement time: Weeks 24 and 36.

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:

60 years

Inclusion criteria:

1. Diagnosis of Rheumatoid Arthritis with evolution time equal to or greater than 2 years. 2. Moderate clinical activity, assessed by DAS28. 3. Have received MTX at a stable dose of 12.5 to 25 mg over a period ≥ 6 months prior to inclusion in the study (patient with inadequate response to treatment with Methotrexate). 4. Age between 18 and 60 years, both inclusive. 5. Laboratory parameters within normal limits or outside the limit of normality, which at the discretion of the investigator are not clinically significant. 6. Female patient of childbearing age with negative pregnancy test and using effective contraceptive methods or male patient using effective methods to prevent procreation. 7. Have received Prednisone (10-20 mg) and Folic Acid (5 mg) for a period ≥ 6 months prior to inclusion in the study. 8. Have received FAME prior to inclusion in the study. 9. Expressed and written willingness by the patient to enter the study with his / her consent to participate.

Exclusion criteria:

1. Pregnancy, puerperium or lactation period. 2. Treatment with another product under investigation at the time of inclusion. 3. Prior treatment with other biological therapy. 4. Complicated rheumatoid arthritis. 5. Other rheumatic diseases of autoimmune origin that affect the osteomioarticular system. 6. Alcoholism. 7. Drug-dependent patient. 8. Concomitant chronic disease. 9. Febrile states due to infectious processes. Or severe septic, not associated with the evolution of the disease. 10. Hematologic disease. 11. Malignant neoplasm. 12. Congenital or acquired immunodeficiency at the time of inclusion. 13. Intellectual or sensory psychological dysfunction that may impede the understanding and fulfillment of study requirements according to the criteria of the clinical investigator.

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

Target sample size:

196

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:

Lidia

Last Name:

Gonzalez Mendez

Specialty:

1st Degree Specialist in General Medicine

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

+53-72085887, +53-72087465

Email :

lidia.gonzalez@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:

Maria

Middle Name:

del Carmen

Last Name:

Dominguez Horta

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

+53-72716022

Email :

mcarmen.dominguez@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:

RPCEC00000230

Date of Registration in Primary Registry:

26/01/2017

Record Verification Date:

2017/01/26

Next update date:

2018/01/26

Link to the spanish version:

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Proceso de Registro

ESAR-814 Study

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