Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

Nanfang Hospital, Southern Medical University138 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

138

Conditions

Rheumatoid Arthritis

Interventions

Iguratimod combined with Tofacitinib;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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28

The proportion of patients with DAS28-CRP\<2.6 at the end of 24 weeks was compared between the two groups. The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity.

Time frame: week 24

Secondary Outcomes

Percentage of American College of Rheumatology [ACR] 20 Criteria Responders at the end of 24 weeks was compared between the two groups.

Percentage of American College of Rheumatology \[ACR\] 20 Criteria Responders at the end of 24 weeks was compared between the two groups.

Time frame: week 24

Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at the end of 24 weeks was compared between the two groups.

Percentage of American College of Rheumatology \[ACR\] 50 Criteria Responders at the end of 24 weeks was compared between the two groups.

Time frame: week 24

Percentage of American College of Rheumatology [ACR] 70 Criteria Responders at the end of 24 weeks was compared between the two groups.

Percentage of American College of Rheumatology \[ACR\] 70 Criteria Responders at the end of 24 weeks was compared between the two groups.

Time frame: week 24

The change of DAS28 score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)

Time frame: up to week 24

Data from ClinicalTrials.gov

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