Home
Login
Help
Search this site:
Registered Trials
By recruitment status
By sponsor
By registration date
Advanced search for trials
Registration process
To register a trial
Sponsor registration form
RPCEC trial registration Data Set
To update a registered trial
To disclosure the results of registered trial
Home
|
Jusvinza in rheumatoid arthritis
View current
Revisions
List all revisions
View
Compare to current
20 April 2022 - 10:00am
by Gladys
19 December 2025 - 10:59pm
by Gladys
Changes to
Record Verification Date
-
2022
/
04
/
20
+
2025
/
12
/
19
Changes to
Next update date
-
2023
/
04
/
20
+
2026
/
12
/
19
Revision of 19 December 2025 - 10:59pm:
Jusvinza in rheumatoid arthritis
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:
ESAR-3
Scientific title:
Subcutaneous administration of Jusvinza and Methotrexate as treatment for patients with moderately active rheumatoid arthritis. ESAR-3 study
Acronym of Scientific Title:
ESAR-3
Secondary indentifying numbers:
IG/JUSVINZASC/AR/2203
Issuing authority of the secondary identifying numbers:
Center for Genetic Engineering and Biotechnology (CIGB)
Primary sponsor:
Center for Genetic Engineering and Biotechnology (CIGB), Havana City
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Center for Genetic Engineering and Biotechnology (CIGB). Ministry of Public Health (MINSAP)
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 :
Second Degree Specialist in Rheumatology
Affiliation:
October 10 Surgical Clinical Hospital
Postal address:
Calzada 10 de Octubre No. 130 e/. Alejandro Ramirez and Agua Dulce. Cerro Municipality
City:
Havana
Country:
Cuba
Zip Code:
10300
Telephone:
+53-78786253
Email address:
hcqdir@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, Hermanos Ameijeiras Surgical Clinical Hospital, Responsible Researcher: Dr.C Araceli Chico Capote, 2nd Degree Specialist in Rheumatology
Havana, Surgical Medical Research Center, Responsible Researcher: MSc. Yolanda Cruz Gomez, Bachelor of Biochemistry. Master in Clinical Laboratory Sciences
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
01/06/2022
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
Intervention(s):
Jusvinza group (Experimental): Jusvinza+ Methotrexate + Prednisone + Folic acid Jusvinza: 0.5 mg, by subcutaneous route, once a week for 4 weeks, followed by every 4 weeks for 20 weeks; Methotrexate: 12.5 mg, by subcutaneous route, once a week for 28 weeks; Prednisone: 7.5 mg, by oral route, daily for 28 weeks; Folic acid: 5 mg, by oral route, once a week for 28 weeks. Placebo group (Control): Placebo + Methotrexate + Prednisone + Folic acid Placebo: A placebo, by subcutaneous route, once a week for 4 weeks, followed by every 4 weeks for 20 weeks; Methotrexate: 12.5 mg, by subcutaneous route, once a week for 28 weeks; Prednisone: 7.5 mg, by oral route, daily for 28 weeks; Folic acid: 5 mg, by oral route, once a week for 28 weeks.
Intervention code:
Antirheumatic Agents
Prednisone
Folic Acid
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):
Clinical response type ACR20 (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. Evaluated on Visual Analogue Scale from 0 to 10, where 0=no pain and 10=maximum pain); 2) Patient's global assessment of disease activity (PGA). Evaluated on a scale from 0 to 10, where 0=no activity and 10=maximum activity; 3) Physician's global assessment of disease activity (Medical doctor(MD) global). Evaluated on a scale from 0 to 10, where 0=no activity and 10=maximum activity; 4) Patient self-assessed disability. Evaluated using the Health Assessment Questionnaire Disability Index (HAQ-DI) questionnaire on a scale of 0 to > 2, where 0= no disability and > 2= severe disability.; 5) Acute phase reactant: CRP or ESR). Measurement time: Weeks 4, 8, 12, 16, 20, 24, 28 and 36
Key secondary outcomes:
1. DAS28 scale (To calculate the DAS28, the following formula must be used: DAS28 = 0.56 (square root of the number of painful joints) + 0.28 (square root of the number of swollen joints) + 0.70 (acute phase reactant) + 0.014 (EGP)). Measurement time: Weeks 0, 4, 8, 12, 16, 20, 24, 28 and 36. 2. Clinical activity of the disease by DAS28 scale (It is classified using the value of the DAS28 scale: Remission [< 2.60]; Lower [2.60 to 3.20]; Moderate [3.30 to 5.10]; High [≥ 5.20]). Measurement time: Week 0, 4, 8, 12, 16, 20, 24, 28 and 36. 3. Clinical response according to EULAR criteria (It is classified based on the reduction in the baseline value of the DAS28 index and the level of disease activity: Good [Reduction ≥1.20 and low activity]; Moderate [Reduction >0.60 and <1.20 and low or moderate activity, or Reduction [≥1.20 and high or moderate activity]; No response [Reduction <0.60, or Reduction <1.20 and high activity]). Measurement time: Weeks 4, 8, 12, 16, 20, 24, 28 and 36. 4. Clinical activity of the disease by CDAI scale (The following formula is used CDAI = Painful joints (0-28) + Swollen joints (0-28) + EGP + EGM. It is classified in: Remission [≤ 2.80]; Low [> 2.80 – 10.00]; Moderate [> 10.00 – 22.00]; High [> 22.00]). Measurement time: Weeks 1, 2 and 3 5. Functional capacity (HAQ-DI questionnaire. Classification of disability in the patient HAQ-DI score in: No disability [0.000]; Mild to moderate [0.000 to 1,000]; Moderate to severe [1,001 to 2,000]; Severe to very severe [> 2,000]). Measurement time: Week 0, 1. 2, 3, 4, 8, 12, 16, 20, 24, 28 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:
19 years
Maximum age:
80 years
Inclusion criteria:
1.- Diagnosis of RA with evolution time greater than or equal to two years. 2.- Age between 19 and 80 years, both inclusive. 3.- Moderate clinical activity, evaluated by DAS28 > 5.10. 4.- Have ≥ 2 swollen joints. 5.- CRP value ≥ 5.10 mg/dL 6.- Have received six months of treatment with MTX in doses of 12.5 mg to 25 mg and be considered refractory to the product. 7.- Laboratory parameters within normal limits (considering the type of processing and equipment used in the CIMEQ clinical laboratory service) or outside the normal limit, which in the investigator's opinion are not clinically significant. The following lower limits are established as ceilings to allow the inclusion of patients: a)- Hemoglobin ≥ 8.5 g/L, value justified by RA activity. b)- Hematocrit 0.28-0.40 in women and 0.28-0.44 in men. c)- White blood cell count ≥ 3000/microliter = 3 x 109 /L. d)- Absolute neutrophil count ≥ 1500/microliter = 1.5 x 109 /L. e)- Platelet count ≥ 100,000/microliter = 100 x 109 /L. 8.- Have received treatment with prednisone (≤ 10 mg as a stable dose) in the last 8 weeks prior to inclusion in the study. 9.- Express and written willingness by the patient to enter the study, by signing the participation consent form.
Exclusion criteria:
1.- Positive for human immunodeficiency virus (HIV). 2.- RA in mild or severe activity, according to the DAS28 index. 3.- Have <2 swollen joints. 4.- Age < 19 or > 80 years. 5.- CRP value < 5.10 mg/dL 6.- Previous dose of MTX below 12.5 mg or less than 6 months of treatment without being considered refractory to the product. 7.- Stable dose of prednisone > 10.0 mg during the previous eight weeks. 8.- No use of prednisone in the last 8 weeks prior to inclusion in the study. 9.- Positive serology for Hepatitis B or Hepatitis C 10.- Value of complementary clinical laboratory outside the normal range and clinically relevant. 11.- Previous treatment with Jusvinza for any reason or illness. 12.- Having participated as a patient included in phase I or phase II studies. 13.- Positive serology for SARS-CoV-2 (as long as it is considered an active pandemic and involves differentiated management of the sick subject). 14.- Pregnancy, puerperium or lactation period. 15.- Female patient of childbearing age who does not use effective contraceptive methods (intrauterine devices, barrier methods or tubal ligation) or male patient who does not use effective methods to prevent procreation (condom or vasectomy). 16.- Male patient with a pregnant female sexual partner. 17.- Treatment with another investigational product at the time of inclusion. 18.- Previous treatment with another biological therapy. 19.- Complicated RA (systemic vasculitis, myocarditis, pericardial effusion with hemodynamic compromise, pleural effusion with respiratory compromise, antiphospholipid syndrome, renal amyloidosis, autoimmune hepatitis, digestive bleeding). 20.- Other rheumatic diseases of autoimmune origin that affect the osteomyoarticular system. 21.- Consumption greater than ¼ bottle of rum or a bottle of wine or three beers, with a frequency greater than three times a week. 22.- Drug-dependent patient. 23.- Concomitant chronic disease such as chronic renal failure (CRF), nephrotic syndrome, acute or chronic liver disease, chronic obstructive pulmonary disease (COPD), decompensated ischemic heart disease, hypertensive encephalopathy, cerebrovascular disease, diabetes mellitus with metabolic decompensation, acute peripheral arterial insufficiency and complications in other organs such as the kidney (Kinmestiel – Wilson, IRC, necrotizing papillitis). 24.- Feverish states due to severe infectious or septic processes, not associated with the evolution of the disease. 25.- Haematological disease. (Acute or chronic leukosis, lymphoma, plasma cell dyscrasias, coagulation disorders) 26.- Malignant neoplasm. 27.- Congenital or acquired immunodeficiency at the time of inclusion. 28.- Psychological, intellectual or sensory dysfunction that may prevent understanding and compliance with the requirements of the study 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:
3
Target sample size:
230
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:
Hugo
Last Name:
Nodarse Cuni
Specialty:
Doctor of Pharmaceutical Sciences.
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB)
Postal Address:
Ave 31 e/t 158 and 190. Cubanacan. Playa
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72080428 ext 107
Email :
hugo.nodarse@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:
Hugo
Last Name:
Nodarse Cuni
Specialty:
Doctor of Pharmaceutical Sciences.
Affiliation:
Center for Genetic Engineering and Biotechnology (CIGB)
Postal Address:
Ave 31 e/t 158 and 190. Cubanacan. Playa
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+53-72080428 ext 107
Email :
hugo.nodarse@cigb.edu.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
"Hermanos Ameijeiras" Surgical Clinical Hospital
"Diez de Octubre" Surgical Clinical Hospital
Surgical Medical Research Center
Status of evaluation:
Approved
Approved
In review
Status of evaluation date of Ethic Committee:
08/03/2022
09/03/2022
15/03/2022
Postal address of Ethic Committee :
Calle San Lazaro # 701 esq. a Belascoain, Centro Habana, La Habana, ZC:10400, Cuba
Calzada 10 de Octubre No. 130 e/. Alejandro Ramirez y Agua Dulce, Cerro, La Habana, ZC:10300, Cuba
Calle 216 y 11-B, Reparto Siboney, Playa, La Habana, ZC:10600, Cuba
Telephone:
+53-78761000
+53-78786253
+53-78581000
Email:
hha@infomed.sld.cu
hcqdir@infomed.sld.cu
bcimeq@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Study completion date:
09/08/2023
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:
RPCEC00000404
Date of Registration in Primary Registry:
20/04/2022
Record Verification Date:
2025/12/19
Next update date:
2026/12/19
Link to the spanish version:
Click here
About the RPCEC
Structure and governance
Policy
Publications
Awards
Communications
News
Useful resources
Fundamentals of the registry
References of clinical trials
Cuban regulations
Other registries
International Clinical Trials Registry Platform