The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

Официальное название

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study

Обзор

A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome

Вмешательства

• Препарат Iguratimod Tablets
  Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
• Препарат Hydroxychloroquine Sulfate Tablets
  Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

Первичные конечные точки

• The change of SSRI-30 between the two groups at 24 weeks [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

• Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24 [Срок оценки: 24 weeks]
• Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24 [Срок оценки: 24 weeks]
• Change in Schimer's test [Срок оценки: 24 weeks]
• Change in Immunoglobulin G (IgG) concentration [Срок оценки: 10 and 24 weeks]
• Change in serum complements C3 and C4 concentration [Срок оценки: 10 and 24 weeks]
• Change in titer of Rheumatoid Factors [Срок оценки: 10 and 24 weeks]

Критерии участия

Критерии включения

• Diagnosed with pSS by meeting the 2016 ACR/EULAR Classification Criteria.
• The patient complained of dry mouth and eyes.
• Positive anti-SSA/Ro-60 antibody at screening.
• IgG≥16 g/L.
• No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;
• Pregnancy test of is negative. Use effective contraceptives during the trial (female)
• Those who did not participate in any drug trial within 12 weeks before enrollment

Критерии исключения

• Pregnant or lactating or planning to get pregnant during the duration of the study.
• Complicated with other CTD
• Complicated with malignancy
• mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse
• serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase/bilirubin >1.5 times the upper normal limit), kidney (Cr≥133mmol/L), lung (FVC % < 60%), blood (white blood cell <3×109/L, HGB<80g/L, PLT<80×109/L), etc.
• Fundus/visual field lesions;
• Allergic to any component of the study drug (IGU and/or HCQ);
• the investigator considers the patient to be unsuitable for entry into the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Second affiliated hospital of zhejiang university，school of medical — Ханчжоу

Публикации

• Chen X, Zhang T, Meng L, Xu C, Jiang L, Wang G, Hou T, Wang H, Han Y, Guan Y, Wang Y, Xue J. Efficacy and safety of iguratimod in patients with primary Sjogren's syndrome: a multicentre randomised controlled trial. RMD Open. 2025 Dec 21;11(4):e006180. doi: 10.1136/rmdopen-2025-006180. PMID 41423293

Идентификаторы

NCT: NCT04981145 · 2021-0391

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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