Jusvinza in adult patients with Rheumatoid Arthritis from Camaguey and Eastern Provinces

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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.

Acronym of Public Title:

MARIANA

Scientific title:

Expanded Intervention Study with Jusvinza, in adult patients with Rheumatoid Arthritis with moderate or severe clinical activity in the Eastern Provinces and Camagüey

Acronym of Scientific Title:

MARIANA

Secondary indentifying numbers:

IG/JusvinzaSC/AR/2305

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 City, and 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)

Authorization date :

15/08/2023

Reference number:

Resolution No. 65/2023

Principal investigator

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

First name:

Osvaldo

Last name:

Caliste Manzano

Medical Specialty :

Second Degree Specialist in Rheumatology

Affiliation:

"Saturnino Lora" Provincial Teaching Clinical Surgical Hospital

Postal address:

Avenida de Los Libertadores S/n entre 4ta y 6ta, Reparto Fomento

City:

Santiago de Cuba

País:

Cuba

Zip Code:

90100

Telephone:

+53-59190756

Email address:

osvaldoc@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:

Camaguey, "Manuel Ascunce Domenech" Provincial Teaching Clinical Surgical Hospital, Raul Cepero Morales, MD. First Degree Specialist in Rheumatology

Las Tunas, “Ernesto Guevara” Clinical Surgical Hospital, Jose Graviel Rodriguez Garrido, MD. First Degree Specialist in Rheumatology

Holguin, "Lucia Inniguez Landin" Clinical Surgical Hospital, Alberto Alberteris Rodriguez, MD. Second Degree Specialist in Intensive Medicine and Emergencies

Granma, "Carlos Manuel de Cespedes" Provincial General Hospital, Clarisbel Hernandez Torres, MD. First Degree Specialist in Rheumatology

Granma, “Celia Sanchez Manduley” Teaching Clinical Surgical Hospital, Norge Miguel Rosabal Callejas, MD. First Degree Specialist in Rheumatology

Guantanamo, “Agosthino Neto” Teaching General Hospital, Aida M. Garcia Sayoux, MD. First Degree Specialist in Rheumatology

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

29/08/2023

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

Health condition(s) code:

Arthritis, Rheumatoid

Arthritis

Joint Diseases

Musculoskeletal Diseases

Health condition keyword:

Intervention(s):

Jusvinza group (experimental): Jusvinza 0.5 mg, by subcutaneous route, during 6 months. The first month a weekly frequency (4 administrations). From the second to the sixth month with a monthly frequency (5 administrations). All patients will continue with their prescribed treatment established by each rheumatologist for rheumatoid arthritis. Essentially, these treatments consist of the combination of methotrexate in doses greater than 10 mg (10 mg - 20 mg), prednisone in doses greater than 5 mg (5 mg, 7.5 mg, 10 mg) and analgesics.

Intervention code:

Antirheumatic Agents

Prednisone

Injections, Subcutaneous

Administration, Oral

Intervention keyword:

Jusvinza, Metotrexate

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):

1) Clinical response type ACR20 (Response is considered when the patient has decrease of at least 20% in the number of painful joints and in the number of swollen joints. Also, at least a 20% improvement in three of the five following parameters: 1. Patient's pain assessment; 2. Patient's global assessment of disease activity (EGP); 3. Physician's global assessment of disease activity; 4. Evaluation of the patient's physical function, using a self-assessment instrument; 5. Determination of acute phase reactants (C-reactive protein or erythrocyte sedimentation rate)). Measurement time: At week 16. 2) Incidence of Adverse Effects (they will be classified according to Type, Intensity (mild, moderate, severe, serious or death), Gravity (Serious or non-serious), Duration (start and end dates of each AE), Action adopted (it will be recorded if there were no changes or definitive interruption of the treatment), Result (recovered, improved, persists, worsened, leaves sequelae or death of the subject), Causal relationship (very probable, probable, possible, improbable, not related, not evaluable), Treatment indicated for the adverse event (it will be specified the treatment that each patient will receive for the AE occurred) Measurement time: from the start of treatment until the final evaluation at week 28.

Key secondary outcomes:

Clinical Response Variables 1. Evaluation of the clinical activity of RA according to DAS28 (calculation of DAS-28 using the formula: DAS28 = 0.56 (square root of the number of painful joints) + 0.28 (square root of the number of swollen joints) + 0.70 (ESR) + 0.014 (EGP). If the patient has DAS28 < 2.6: it will be classified in Remission; 2.6 < DAS28 < 3.2: Mild disease activity; 3.2 < DAS28 < 5.2: Moderate disease activity; DAS28 > 5.2: Severe disease activity)). Measurement time: At baseline and, At weeks 16 and 28. 2. Evaluation of the response to treatment according to EULAR Criteria (The response to treatment will be determined according to the following: Equal or greater than 1.2: Good Response; 0.6 to 1.2: Moderate Response; Less than 0.6: Poor therapeutic response) Measurement time: At weeks 16 and 28. 3. Evaluation of the Clinical Activity of RA according to CDAI ((in patients for whom DAS28 value cannot be calculated) Disease activity will be determined according to CDAI ≤ 2.8: Remission; 2.8 < CDAI < 10.0: Low; 10.0 < CDAI < 22.0: Moderate; CDAI > 22.0: High). Measurement time: At baseline and, At weeks 16 and 28. Laboratory, molecular and cellular variables 1. Hematological: Hemoblogin (g/L), Hematocrit, Biomarkers of inflammation (Leukocyte count (x10*9/L), Neutrophils%, Lymphocytes%, Monocytes%, Eosinophils%, Basophils%, Count of platelets (x10*9/L)), Erythrocyte sedimentation rate (mm/h) and C-reactive protein (mg/L). Measurement time: Before treatment, weeks 16 and 28. 2. Lipid profile (Value of total cholesterol concentration in blood (mmol/L), Triglycerides (mmol/L), HDL-cholesterol (mmol/L), LDL-cholesterol (mmol/L)). Measurement time: At baseline, and at weeks 16 and 28. 3. Blood biochemistry (glycemia ( mmol/L), ALAT (U/L), ASAT (U/L), GGT (U/L), total bilirubin (µmol/L), serum alkaline phosphatase (U/L), total protein (µmol/L) and creatinine (µmol/L)) Measurement time: At baseline, and At weeks 16 and 28. 4. Cituria (altered or normal). Measurement time: At baseline, and at weeks 16 and 28.

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1) Time of RA evolution equal to or greater than 2 years. 2) Moderate or severe clinical activity, assessed by DAS28. 3) Age greater than 19 years. 4) Laboratory parameters within normal limits or outside the normal limits, which at the investigator's criteria are not clinically significant (Hematological (Hematocrit 0.28-0.40 in women and 0.28-0.44 in men, Leukocyte count ≥ 3000/µL = 3 x 10*9 /L, Platelet count ≥ 100000/µL = 100 x 10*9 /L), Biochemicals (Hepatic: ALAT (TGP), ASAT (TGO), alkaline phosphatase (upper normal reference limit), Glycemia (normal reference value), Bilirubin (normal reference value), serum creatinine (normal reference value). 5) NON-pregnant female patient who uses effective contraceptive methods (intrauterine devices, barrier methods or tubal ligation) or male patient who uses effective methods to avoid procreation (condom or vasectomy). 6) Patient who, before being included, received treatment with DMARDs, including MTX (12.5-25 mg) and Prednisone (5-20 mg) (among the DMARDs indicated/received by the patient prior to inclusion in the study, the following could be mentioned: gold salts, D-penicillamine, sulfasalazine, chlorambucil, cyclophosphamide, cyclosporine A, azathioprine, antimalarials, leflunomide). 7) Patient´s expressed and written willingness to enroll in the study by signing the consent to participate.

Exclusion criteria:

1) Pregnancy, puerperium or lactation period. 2) Treatment with another investigational product at the time of inclusion. 3) Serious rheumatoid arthritis (systemic vasculitis, myocarditis, pericardial effusion with hemodynamic compromise, pleural effusion with respiratory compromise, antiphospholipid syndrome, renal amyloidosis, autoimmune hepatitis, digestive bleeding). 4) Mono-articular Rheumatoid Arthritis. 5) Other rheumatic diseases of autoimmune origin that affect the osteomyoarticular system. 6) Alcoholism. 7) Drug-dependent patient. 8) Concomitant chronic disease such as chronic renal failure (CKD), nephrotic syndrome, acute or chronic liver disease, chronic obstructive pulmonary disease (COPD), decompensated ischemic heart disease, hypertensive encephalopathy, cerebrovascular disease (CVA), diabetes mellitus with metabolic decompensation, arterial insufficiency acute peripheral and complications in other organs such as kidney (Kinmestiel - Wilson, Necrotizing papillitis). 9) Febrile states due to severe infectious or septic processes not associated with the evolution of the disease. 10) Hematological disease (acute or chronic leukosis, lymphoma, plasma cell dyscrasias, coagulation disorders). 11) Malignant neoplasm. 12) Congenital or acquired immunodeficiency at the time of inclusion. 13) Sensory or intellectual psychological dysfunction that may prevent understanding and compliance with the study requirements according to the clinical investigator's criteria.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

NA

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:

Maria

Middle Name:

del Carmen

Last Name:

Domínguez Horta

Specialty:

Graduated in Biochemistry; PhD in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacán, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+537-271-6022

Email :

mcarmen.dominguez@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:

Domínguez Horta

Specialty:

Graduated in Biochemistry; PhD in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacán, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+537 271-6022

Email :

mcarmen.dominguez@cigb.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

"Manuel Ascunce Domenech" Provincial Teaching Clinical Surgical Hospital

“Ernesto Guevara” Clinical Surgical Hospital

"Lucia Inniguez Landin" Clinical Surgical Hospital

"Carlos Manuel de Cespedes" Provincial General Hospital

“Celia Sanchez Manduley” Teaching Clinical Surgical Hospital

"Saturnino Lora" Provincial Teaching Clinical Surgical Hospital

“Agosthino Neto” Teaching General Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/07/2023

04/07/2023

05/07/2023

03/07/2023

30/06/2023

07/07/2023

Postal address of Ethic Committee :

Carretera Central Oeste no. 305 entre Ave. Hospital y Calle 9 Rpto. Sanchez Soto, Camaguey ZC.70100, Cuba

Ave. 2 de diciembre # 1 % Ave. Carlos J. Finlay y Carretera Central Holguin. Las Tunas ZC. 75 100, Cuba

Ave Celia Sanchez Manduley # 1 entre Circunvalacion y Carretera de Valle. Holguin. ZC. 80 100, Cuba

Carretera Km 1. Via Santiago de Cuba. Bayamo. Granma ZC. 85 100, Cuba

Carretera Campechuela Km1 Esquina Avenida Camilo Cienfuegos. Manzanillo. Granma ZC. 87510, Cuba

Avenida de Los Libertadores S/n entre 4ta y 6ta, Reparto Fomento. Santiago de Cuba ZC. 90100, Cuba

Calle 5 Oeste entre 9 y 13 Norte. Guantanamo ZC. 95 100, Cuba

Telephone:

+5353386583

+5355617068

+5355993149

+5358952402

+5358582195

+5359190756

+5355048384

Correo electrónico:

dirmad.cmw@infomed.sld.cu

herdir@ltu.sld.cu

webmasterhcqho@infomed.sld.cu

hcmc@grm.sld.cu

hcsm@grannet.grm.sld.cu

dirgneralhpsl@infomed.sld.cu

dirhgdangt@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

534

Study completion date:

18/06/2024

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:

RPCEC00000433

Date of Registration in Primary Registry:

27/02/2024

Record Verification Date:

2025/09/16

Next update date:

2026/09/16

Link to the spanish version:

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Jusvinza in adult patients with Rheumatoid Arthritis from Camaguey and Eastern Provinces

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