Comparison of the effect of iguratimod and hydroxychloroquine in the treatment of primary Sjögren's syndrome

Comparison of the effect of iguratimod and hydroxychloroquine on regulatory B cells in the treatment of primary Sjögren's syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15824224

Enrollment

Registered

2025-05-15

Start date

2020-12-30

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with primary Sjögren's syndrome Musculoskeletal Diseases

Interventions

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 p

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 wer

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

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 14 × 10?/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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

China

Contacts

Public ContactJing Yang

yangjing_2025yj@126.com+86 13890116000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 29, 2026