A Study of Iguratimod in Combination With Tofacitinib in RA Patients

NCT06945666 | Not Yet Recruiting Phase 4

• 1 other identifier: KY-2025-072
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis (RA) is a common chronic inflammatory autoimmune disease characterized by synovitis, which can cause joint pain, deformity, and extra-articular symptoms, seriously affecting the quality of life and lifespan of patients. Currently, the treatment of RA adopts a target attainment strategy, aiming to control the disease and reduce the disability rate. Although traditional disease-modifying antirheumatic drugs (DMARDs) can alleviate symptoms, they have slow onset, many side effects, and cannot completely stop the disease progression. Among biological DMARDs (bDMARDs), tumor necrosis factor-α (TNF-α) inhibitors have better effects, but some patients have poor responses and their conditions are not effectively controlled, thus new treatment options are urgently needed. This study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment.

Conditions

Rheumatoid Arthritis (RA

Keywords

iguratimod; tofacitinib

Outcome Measures

Primary Outcomes (4)

• ACR20 (%)

  American College of Rheumatology 20% improvement criteria (ACR20) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.

  12 and 24 weeks of treatment

• ACR50 (%)

  American College of Rheumatology 50% improvement criteria (ACR50) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.

  12 and 24 weeks of treatment

• ACR70 (%)

  American College of Rheumatology 70% improvement criteria (ACR70) response rates(Expressed as a percentage value) at 12 and 24 weeks of treatment.

  12 and 24 weeks of treatment

• DAS28

  Changes in disease activity score (DAS28) from baseline at 12 and 24 weeks of treatment. This score has no unit of measure.

  12 and 24 weeks of treatment

Secondary Outcomes (5)

• ESR (mm/h)

  4, 8, 12, and 24 weeks of treatment

• CRP (mg/L)

  4, 8, 12, and 24 weeks of treatment

• RF (IU/L)

  4, 8, 12, and 24 weeks of treatment

• CCP (U/L)

  4, 8, 12, and 24 weeks of treatment

• AE

  From baseline to 24 weeks of treatment

Study Arms (1)

treatment group

EXPERIMENTAL

This study adopted a parallel controlled design, setting up a combined treatment group without an additional control group. The patients in the group received treatment with the standard dose of Iguratimod combined with tofacitinib. The recommended dose of Iguratimod is 25mg bid and that of tofacitinib is 5mg bid. During the treatment, other background therapeutic drugs were allowed to be used (determined by the prescribers), but other anti-rheumatic drugs that affected the study results were not allowed.

Drug: Combined therapy of Iguratimod and tofacitinib

Interventions

Combined therapy of Iguratimod and tofacitinib DRUG

This study aims to evaluate the efficacy and safety of the combination of iguratimod and tofacitinib in the treatment of RA patients with poor responses to traditional or biological DMARDs, providing evidence-based support for clinical treatment.

Also known as: Combined therapy, Iguratimod and tofacitinib

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, male or female.
• Meets the classification criteria for rheumatoid arthritis established by the American College of Rheumatology (ACR) and the European League against Rheumatism (EULAR) in 2010.
• Meeting any of the following treatment conditions with poor efficacy (DAS28 score as moderate-high disease activity) : receiving conventional DMARDs therapy such as methotrexate for at least 3 months; Treatment with biological agents such as TNFi for at least 3 months; Treatment with eramode or tofaciib alone for at least 3 months.
• Understand the procedure and content of the test, and voluntarily sign the informed consent.

You may not qualify if:

• Patients with a known allergy to Iguratimod or tofacitinib.
• Patients who have previously used eramode or tofaciib and discontinued treatment for safety reasons;
• At the time of screening, they are in the acute phase of acute infection or chronic infection;
• At the time of screening, have a history of active TB or TB screening suggests latent infection with mycobacterium tuberculosis;
• A medical condition or history of congestive heart failure at the time of screening;
• Include other ongoing projects or studies;
• Severe, progressive, uncontrolled disorders of vital organs and systems, as well as other medical conditions Any circumstances that should not be included in this collection.

Sponsors & Collaborators

• Jie Chang: lead

Study Sites (1)

4th Affiliated Hospital, School of Medicine, Zhejiang University

Yiwu, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib; Psychotherapy, Multiple; iguratimod

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jie Chang

CONTACT

+8613705790575; changjie7311@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)