Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

Last updated: March 26, 2023
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT05803135
NFEC-2022-282
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of Iguratimod combined with Tofacitinib in the treatment of csDMARD-IR patients with active moderate-to-severe rheumatoid arthritis

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients who meet the following inclusion criteria will be eligible to participate in thestudy:

  1. Male or female aged 18-65 years old;
  2. Weight not less than 40kg;
  3. Since the diagnosis of RA, the course of disease was ≥6 months;
  4. Patients who meet RA standards in 1987 and 2010 ;
  5. RA patients with moderate to high disease activity (DAS28 > 3.2) at the time ofscreening;
  6. Active RA (≥6 joints swelling [66 joints count]; ≥Tenderness of 6 joints [68 jointcounts]; ESR>28 mm/h or C-reactive protein (CRP) >1.0 mg/dL);
  7. Poor response or intolerance to at least one DMARD, including csDMARDs, bDMARDs, butnot tsDMARDs;
  8. Previous use of any JAK inhibitor was discontinued for six months before enrollment;
  9. For patients who have used DMARDs, the washout criteria must be met;
  10. Written informed consent;

Exclusion

Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study:

  • Pregnant or lactating women;
  • Platelet count < 10^9/L, or white blood cell < 310^9/L, or absolute neutrophil count < 1.210^9/L, or Hemoglobin < 9 g/dL or hematocrit <30%;
  • According to Cockcroft-Gault, the glomerular filtration rate was ≤40 ml/min.
  • ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L;
  • Subjects with serious cardiovascular, renal, hematologic or endocrine diseases;
  • A history of autoimmune rheumatic diseases other than Sjogren's syndrome;
  • Subjects with uncontrolled infection;
  • Subjects receiving live vaccines within 6 weeks prior to study entry;
  • history of alcohol or drug abuse and abstinence for less than 6 months prior to thefirst use of the study drug;
  • Subjects participating in other clinical study within 3 months prior to study entry;
  • Have a history of malignant tumor;
  • History of recurrent herpes zoster, diffuse herpes zoster;
  • People who are allergic to any of the study drugs;
  • Other conditions in which the investigator deemed the patient inappropriate for trialentry;

Study Design

Total Participants: 138
Study Start date:
March 31, 2023
Estimated Completion Date:
December 30, 2025

Study Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Iguratimod (25mg, twice daily) combined with Tofacitinib (5mg, twice daily) or placebo (25mg, twice daily) combined with Tofacitinib (5mg, twice daily).