Comparison of the effect of iguratimod and hydroxychloroquine in the treatment of primary Sjögren's syndrome
| ISRCTN | ISRCTN15824224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15824224 |
| Secondary identifying numbers | PK-CF-2020-Z-1231, 2022FH006 |
- Submission date
- 12/05/2025
- Registration date
- 15/05/2025
- Last edited
- 14/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Several studies have shown that iguratimod (IGU) has achieved certain efficacy in the treatment of primary Sjögren's syndrome (pSS). However, there is no study examining whether IGU affects regulatory B cells (Bregs) in patients with pSS. The purpose of this study is to evaluate the effect of IGU and hydroxychloroquine (HCQ) in the treatment of pSS and to analyse the influence of these two drugs on Bregs in peripheral blood.
Who can participate?
Patients with pSS aged 18-65 years
What does the study involve?
Treatment in the IGU group was as follows: ≤10 mg of prednisone per day, 25 mg of IGU twice a day; treatment in the HCQ group was as follows: ≤10 mg of prednisone per day, 0.2 g of HCQ twice a day. Questionnaires were used to assess disease activity.
What are the possible benefits and risks of participating?
Both IGU and HCQ may reduce the disease activity and fatigue score of patients with pSS. IGU may be superior to HCQ in reducing IgG levels.
This study does not involve any risks.
Where is the study run from?
Mianyang Central Hospital, China
When is the study starting and how long is it expected to run for?
December 2029 to June 2023
Who is funding the study?
1. Guangzhou Pukang Charitable Foundation
2. The Incubation Project of Mianyang Central Hospital
Who is the main contact?
Jing Yang, yangjing_2025yj@126.com
Contact information
Public, Scientific, Principal Investigator
Mianyang Central Hospital
No. 12, Changjia Lane, Jingzhong Street
Mianyang
621000
China
| Phone | +86 13890116000 |
|---|---|
| yangjing_2025yj@126.com |
Study information
| Study design | Single-center interventional double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparison of the effect of iguratimod and hydroxychloroquine on regulatory B cells in the treatment of primary Sjögren's syndrome |
| Study objectives | Iguratimod may be more effective than hydroxychloroquine in the treatment of primary Sjögren's syndrome |
| Ethics approval(s) |
Approved 29/12/2020, Ethic Committee of the MianYang Central Hospital (No. 12, Changjia Lane, Jingzhong Street, Mianyang, 621000, China; +86 0816-2239224; myszxyygcp@163.com), ref: S-2020-048 |
| Health condition(s) or problem(s) studied | Patients with primary Sjögren's syndrome |
| Intervention | The patients were randomly assigned to an iguratimod (IGU) group (n = 30) or a hydroxychloroquine (HCQ) group (n = 30) at a ratio of 1:1. All the patients were allowed to receive <0 mg of prednisone per day and vitamin D and calcium for 24 weeks to prevent osteoporosis; 25 mg of IGU was administered orally twice a day in the IGU group, and 0.2 g of HCQ was administered orally twice a day in the HCQ group. Treatment lasts 24 weeks. Follow-up evaluation and records were performed after treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Iguratimod, hydroxychloroquine |
| Primary outcome measure | The following primary outcome measures were assessed at baseline and week 24: 1. Disease activity was measured using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) and the EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI) 2. Patient global assessment was measured using a 10-cm Visual Analogue Scale (VAS) 3. Fatigue degree was measured using the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire |
| Secondary outcome measures | Clinical and laboratory variables B lymphocytes and Bregs (CD19+ CD24 hiCD38hi, CD19+ CD24+ CD27+ and CD19+ CD5+ CD1d+ B cells) were measured using flow cytometric at baseline and week 24 |
| Overall study start date | 29/12/2020 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Aged 18–65 years 2. No glucocorticoids, immunosuppressants or biological agents within 3 months before baseline 3. Consent to contraception during the trial and within 3 months after the end of the trial |
| Key exclusion criteria | 1. Patients with other immune system diseases, such as autoimmune liver disease, RA, systemic lupus erythematosus, scleroderma, myositis or Hashimoto's thyroiditis 2. Patients with serious organ involvement, such as severe pericardial effusion (echocardiography showing pericardial effusion thickness >10 mm), pulmonary interstitial lesions (high-resolution computed tomography showing ground-glass opacity or honeycomb lung), renal tubular acidosis (serum bicarbonate level >30 mmol/L and a urine ph value persistently >6.0) or atrophic gastritis (endoscopy showing gastric mucosal atrophy) 3. Patients with underlying cardiac, pulmonary, renal, gastrointestinal or metabolic conditions 4. Patients with chronic or latent infectious diseases or a history of malignancy, mental diseases or alcohol abuse 5. Pregnant and lactating women; patients with the following abnormal indicators – haemoglobin ≤90 g/L, platelet count <100 × 10⁹/L, white blood cell count <3.0 × 10⁹/L or >14 × 10⁹/L, estimated glomerular filtration rate ≤45 ml/min/1.73 m², total bilirubin >1.5 × upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase both >1.5 × ULN |
| Date of first enrolment | 30/12/2020 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Mianyang
621000
China
Sponsor information
Hospital/treatment centre
No. 12, Changjia Lane, Jingzhong Street
Mianyang
621000
China
| Phone | +86 0816-2569485 |
|---|---|
| myszxyygcp@163.com | |
| Website | http://www.myzxyy.com/ |
"ROR" |
https://ror.org/00s528j33 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to privacy reasons. |
Editorial Notes
12/05/2025: Study's existence confirmed by the Ethics Committee of the MianYang Central Hospital.
