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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Iguratimod Tablets

    Drug

    Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.

  • Hydroxychloroquine Sulfate Tablets

    Drug

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

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: IGU GroupExperimental treatment 1 intervention
Group B: HCQ GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change of SSRI-30 between the two groups at 24 weeks

SS Responder Index (SSRI) is a composite endpoint, investigators defined an SSRI-30 response as a ≥30% improvement in at least two of five outcome measures (patient-assessed visual analogue scale scores for fatigue, oral dryness and ocular dryness, unstimulated whole salivary flow and ESR at 24 weeks

Time frame
24 weeks

Secondary outcomes

1

Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24

The ESSPRI is composed of 3 scales - dryness, fatigue, and pain. Each scale is measured 0 - 10, 0 being no symptoms, 10 being maximal imaginable dryness, fatigue or pain. The total score is the mean score of the three scales. Baseline ESSPRI total score will be compared to week 24, end of treatment, ESSPRI total score.

Time frame
24 weeks
2

Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24

The ESSDAI is a disease activity measurement that has 12 domains. The score of each domain is the product of the weight of the domain by the level of activity. Activity levels are 0 - 3, 0 being no activity, 3 being high activity. The total score is the sum of the score of all domains. Change in total score from BL to week 24 will be measured.

Time frame
24 weeks
3

Change in Schimer's test

The change from baseline in Schimer's test at 24 weeks. The Schirmer's test assesses tear secretion.

Time frame
24 weeks
4

Change in Immunoglobulin G (IgG) concentration

The change from baseline in IgG concentration at 10 and 24 weeks.

Time frame
10 and 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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