Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

NCT ID: NCT05803135

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2025-12-30

Brief 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

Detailed 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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Double-Blind Iguratimod

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

Group Type: ACTIVE_COMPARATOR

Iguratimod combined with Tofacitinib;

Intervention Type: DRUG

Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily); Placebo of Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily)

Double-Blind Placebo

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

Group Type: PLACEBO_COMPARATOR

Iguratimod combined with Tofacitinib;

Intervention Type: DRUG

Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily); Placebo of Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily)

Interventions

Iguratimod combined with Tofacitinib;

Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily); Placebo of Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily)

Intervention Type: DRUG

Other Intervention Names

Placebo of Iguratimod combined with Tofacitinib

Eligibility Criteria

Inclusion Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NFEC-2022-282

Identifier Type: -

Identifier Source: org_study_id