A study of the safety and efficacy of "Eryxin" in patients with rheumatoid arthritis
| ISRCTN | ISRCTN13331870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13331870 |
| Secondary identifying numbers | ЭРИН36/35ОС/30Уз/2023/1876 |
- Submission date
- 02/02/2024
- Registration date
- 07/02/2024
- Last edited
- 14/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rheumatoid arthritis is characterised by joint inflammation and destruction and leads to functional limitations, working disability, and a poor quality of life. It has an estimated adult prevalence of 0.8% worldwide and is more common in females. Synovial inflammation can cause erosive changes that are generally irreversible and often occur early in the disease process. Eryxin is a new drug with immunomodulatory and anti-inflammatory properties. The main goal of the study is to determine the safety of Eryxin and its efficacy in patients with rheumatoid arthritis
Who can participate?
Adults age 18 years old and over with rheumatoid arthritis
What does the study involve?
Participants will be asked to join this study while they are at a Clinic of Tashkent Medical Academy. The study will include the following periods:
- Screening - pre-screening of patients and initiation of therapy - randomization of patients, initiation of study therapy. The duration of the period should not be more than 24 hours.
- Therapy period (total duration of 30 days), application of study drug and/or traditional therapy, patient assessment, registration of AE.
What are the possible benefits and risks of participating?
Possible benefits for participants include reducing pain and improving the quality of life. However, there may be adverse effects, which are the main risk for participants.
Where is the study run from?
The study is being run by the Clinic of Tashkent Medical Academy and takes place in the Clinic of Tashkent Medical Academy.
When is the study starting and how long is it expected to run for?
September 2023 to April 2025
Who is funding the study?
Namangan Pharm Plant LTD
Who is the main contact?
Mr. Umid Akbarov, akbarov.umid@gmail.com
Contact information
Public, Scientific, Principal Investigator
Akkurgan str. 6 passage, 84b
Tashkent
100052
Uzbekistan
| Phone | +998903219229 |
|---|---|
| akbarov.umid@gmail.com |
Study information
| Study design | Interventional single-center open-label non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | 44986 PIS.pdf |
| Scientific title | An open controlled non-randomized clinical trial to study the clinical efficacy of the drug "Eryxin" produced by "Namangan Pharm Plant" |
| Study objectives | Is "Eryxin" safe and effective for the treatment of rheumatoid arthritis |
| Ethics approval(s) |
Approved 09/11/2023, Ethics Committee of the Ministry of Health of the Republic of Uzbekistan (Oybek street, 45, Tashkent, 100015, Uzbekistan; +998712563738; info@minzdrav.uz), ref: 7-5/1806 |
| Health condition(s) or problem(s) studied | Safety and efficacy in patients with rheumatoid arthritis |
| Intervention | Current interventions as of 19/03/2025: This study is an open-label non-randomized controlled trial. Participants will be divided into 2 groups. The first group will receive conventional therapy (methotrexate 15mg/week and tofacitinib 10mg/day) + "Eryxin" on a specialized intravenous regimen for 30 days (from day 1 to 10 - 1 ml 2 times a day, from day 11 to 30 - 2 ml 2 times a day). The second group will receive conventional therapy (methotrexate 15mg/week and tofacitinib 10mg/day) for 30 days. _____ Previous interventions: This study is an open-label randomized controlled trial. Participants will be divided into 2 groups. Participants will be randomized by block randomization. Block size - 4. The first group will receive conventional therapy (methotrexate 15mg/week and tofacitinib 10mg/day) + "Eryxin" on a specialized intravenous regimen for 30 days (from day 1 to 10 - 1 ml 2 times a day, from day 11 to 30 - 2 ml 2 times a day). The second group will receive conventional therapy (methotrexate 15mg/week and tofacitinib 10mg/day) for 30 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Eryxin, Methotrexate, Tofacitinib |
| Primary outcome measure | Current primary outcome measure as of 11/04/2025: Tolerability will be assessed throughout the study (from the first use of the study drug) using the following data: 1. Adverse event report data 2. Physical examination data, vital signs (BP, HR, HRD, body temperature) 3. Pain will be measured using a visual analogue scale (VAS) on day 1 and day 30 4. Inflammation activity of rheumatoid arthritis will be measured using the Disease Activity Score-28 (DAS-28) index on day 1 and day 30 Previous primary outcome measure: Tolerability will be assessed throughout the study (from the first use of the study drug) using the following data: 1. Adverse event report data 2. Physical examination data, vital signs (BP, HR, HRD, body temperature) 3. Pain will be measured using a visual analogue scale (VAS) on day 1, day 10, and day 30 4. Inflammation activity of rheumatoid arthritis will be measured using the Disease Activity Score-28 (DAS-28) index on day 1, day 10 and day 30 |
| Secondary outcome measures | Current secondary outcome measure as of 11/04/2025: 1. Immunological changes measured using flow cytometry (CD3, CD4, CD8 cells) and ELISA (IL-1, IL-6, TNF) at day 1 and day 30 Previous secondary outcome measure: 1. Immunological changes measured using flow cytometry (CD3, CD4, CD8 cells) and ELISA (IL-1, IL-6, TNF) at day 1, day 11-15, and day 30 |
| Overall study start date | 01/09/2023 |
| Completion date | 30/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Adults aged 18 years old and over 2. Written informed consent to participate in the study 3. With rheumatoid arthritis |
| Key exclusion criteria | 1. Pregnancy 2. Lactation 3. Children aged under 18 years old 4. Presence of hypersensitivity to the drug components 5. Patient's participation in other clinical trials within the last 30 days 6. Absence of informed written consent of the patient to participate in a clinical trial 7. Hypersensitivity to the drug 8. Genetically determined glucose-6-phosphate dehydrogenase deficiency (risk of hemolytic anemia) 9. History of gastrointestinal bleeding or perforation associated with NSAID therapy 10. Active peptic ulcer/bleeding or a history of recurrent peptic ulcer/bleeding (two or more cases of confirmed ulcer or bleeding) 11. Hypersensitivity reactions (symptoms of asthma, rhinitis, angioedema, or urticaria) to other NSAIDs, including aspirin 12. Severe liver dysfunction 13. Severe impairment of renal function 14. Chronic heart failure in decompensation stage |
| Date of first enrolment | 05/02/2024 |
| Date of final enrolment | 01/11/2024 |
Locations
Countries of recruitment
- Uzbekistan
Study participating centre
Tashkent
100109
Uzbekistan
Sponsor information
Industry
North Industrial Zone, Sanoatchi str., 17
Namangan
160100
Uzbekistan
| Phone | +998782756789 |
|---|---|
| namanganpharmplant@gmail.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned a publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Umidbek Akbarov (akbarov.umid@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Russian | 07/02/2024 | No | Yes | |
| Basic results | 14/04/2025 | No | No | ||
| Protocol file | in Russian | 14/04/2025 | No | No |
Additional files
- 44986 PIS.pdf
- in Russian
- ISRCTN13331870_BasicResults.pdf
- ISRCTN13331870 Protocol (Russian).pdf
- in Russian
Editorial Notes
14/04/2025: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. Uploaded protocol (not peer-reviewed) as an additional file.
11/04/2025: The primary and secondary outcome measures were updated.
19/03/2025: The following changes were made to the trial record:
1. The scientific title was changed from "An open controlled randomized clinical trial to study the clinical efficacy of the drug "Eryxin" produced by "Namangan Pharm Plant"" to "An open controlled non-randomized clinical trial to study the clinical efficacy of the drug "Eryxin" produced by "Namangan Pharm Plant"".
2. The study design was changed from "Interventional single-center open-label randomized controlled trial" to "Interventional single-center open-label non-randomized controlled trial".
3. The interventions were changed.
4. The plain English summary was updated to reflect these changes.
07/05/2024: The recruitment end date was changed from 01/05/2024 to 01/11/2024.
02/02/2024: Study's existence confirmed by the Ethics Committee of The Ministry of Health of The Republic of Uzbekistan.
