Health Trials

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

ConditionPrimary Sjögren's Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Iguratimod Tablets
  • Hydroxychloroquine Sulfate Tablets

Treatment groups

78 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov