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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PK-CF-2020-Z-1231, 2022FH006 |
| Sponsor | Mianyang Central Hospital |
| Funders | Guangzhou Pukang Charitable Foundation, The Incubation Project of Mianyang Central Hospital |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional double-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Iguratimod, hydroxychloroquine |
| Primary outcome measure(s) |
The following primary outcome measures were assessed at baseline and week 24: |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/05/2025: Study's existence confirmed by the Ethics Committee of the MianYang Central Hospital.
