Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

Nanfang Hospital, Southern Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Iguratimod combined with Tofacitinib;

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05803135

NFEC-2022-282

Details and patient eligibility

About

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

Full 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).

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who meet the following inclusion criteria will be eligible to participate in the study:

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 of screening;
6. Active RA (≥6 joints swelling [66 joints count]; ≥Tenderness of 6 joints [68 joint counts]; 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, but not 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 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 < 3*10^9/L, or absolute neutrophil count < 1.2*10^9/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 the first 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 trial entry;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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138 participants in 2 patient groups, including a placebo group

Double-Blind Iguratimod

Active Comparator group

Description:

Iguratimod (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months)

Treatment:

Drug: Iguratimod combined with Tofacitinib;

Double-Blind Placebo

Placebo Comparator group

Description:

Placebo (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months)

Treatment:

Drug: Iguratimod combined with Tofacitinib;