Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

NCT05803135 | Unknown Phase 4 DMC

• 1 other identifier: NFEC-2022-282
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  week 24

Secondary Outcomes (12)

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

  week 24

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

  week 24

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

  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)

  up to week 24

• The change of Clinical Disease Activity Index (CDAI) score between the two groups at the end of 24 weeks was compared with the baseline value (week 0)

  up to week 24

Other Outcomes (3)

• The change of EULAR Sjögren's Syndrome Discasc Activity Index (ESSDAI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0)

  up to week 24

• The change of EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI) score between the two groups associated with Sjögren's Syndrome (SS) at the end of 24 weeks was compared with the baseline value (week 0)

  up to week 24

• Number of participants with"adverse events (AEs)"

  up to week 24

Study Arms (2)

Double-Blind Iguratimod

ACTIVE COMPARATOR

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

Drug: Iguratimod combined with Tofacitinib;

Double-Blind Placebo

PLACEBO COMPARATOR

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

Drug: Iguratimod combined with Tofacitinib;

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)

Also known as: Placebo of Iguratimod combined with Tofacitinib

Double-Blind Iguratimod; Double-Blind Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-65 years old;
• Weight not less than 40kg;
• Since the diagnosis of RA, the course of disease was ≥6 months;
• Patients who meet RA standards in 1987 and 2010 ;
• RA patients with moderate to high disease activity (DAS28 \> 3.2) at the time of screening;
• 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);
• Poor response or intolerance to at least one DMARD, including csDMARDs, bDMARDs, but not tsDMARDs;
• Previous use of any JAK inhibitor was discontinued for six months before enrollment;
• For patients who have used DMARDs, the washout criteria must be met;
• Written informed consent;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Jiangsu Simcere Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, controlled, multicenter study

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: March 31, 2023
• Primary Completion: January 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share