Study of Iguratimod in Sjögren's Syndrome

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Sjogren's Syndrome

Treatments

Drug: Iguratimod

Study type

Interventional

Funder types

Other

Identifiers

NCT03023592
PUMCH170115

Details and patient eligibility

About

A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome

Full description

In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
  • Positive dry eyes and (or) dry mouth symptoms
  • Hyperglobulinemia

Exclusion criteria

  • Complicated with other systemic autoimmune diseases
  • Severe complications of Sjogren's syndrome
  • Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
  • Active infections or chronic infectious diseases
  • A history of malignancies
  • Pregnancy or breathfeeding
  • Inability to comply with the study protocol for any other reason

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Iguratimod
Experimental group
Description:
Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks.
Treatment:
Drug: Iguratimod

Trial contacts and locations

0

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Central trial contact

Hua Chen, Dr.

Data sourced from clinicaltrials.gov

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