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A multicenter prospective study of Iguratimod in combination with tofacatib in patients with rheumatoid arthritis with poor response to conventional or biological DMARDs

A multicenter prospective study of Iguratimod in combination with tofacatib in patients with rheumatoid arthritis with poor response to conventional or biological DMARDs

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103373
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Treatment group:The combination of Iguratimod or tofacitinib.

Sponsors

The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.The condition satisfies the rheumatoid arthritis classification criteria jointly established by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) in 2010; 2.Meeting any of the following treatment criteria with suboptimal efficacy (DAS28 score indicating moderate to high disease activity): Receiving conventional DMARD therapy, such as methotrexate, for a minimum duration of 3 months; Undergoing treatment with biologic agents, such as TNF inhibitors, for at least 3 months; Receiving treatment with either eramode or tofacitinib monotherapy for a minimum period of 3 months; 3.Understand the procedure and content of the test, and sign the informed consent voluntarily; 4. Age 18 or older; Open to all genders.

Exclusion criteria

Exclusion criteria: 1.Patients who are known to have an allergy to Iguratimod or tofacitinib. 2.Patients who have previously used Iguratimod or tofacitinib and discontinued treatment for safety reasons. 3.At the time of screening, they were in the acute phase of acute infection or chronic infection. 4.At screening, a positive hepatitis B DNA and/or hepatitis C RNA screening is suggestive of viral hepatitis, and only healthy HBsAg positive carriers are not considered as exclusion criteria, and the inclusion of this patient is at the discretion of the investigator. 5.At the time of screening, there was a history of active TB or TB screening suggested latent infection with mycobacterium tuberculosis. 6.Disease or history of congestive heart failure at the time of screening. 7.Patients have been enrolled in other ongoing projects or studies. 8.Severe, progressive, uncontrolled, vital organ and system disorders, and any other condition that the physician deems inappropriate for inclusion in this collection.

Design outcomes

Primary

MeasureTime frame
The achievement rates for ACR20, ACR50, and ACR70.;

Secondary

MeasureTime frame
Erythrocyte sedimentation rate;C-reactive protein;

Countries

China

Contacts

Public ContactChang Jie

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

8012012@zju.edu.cn+86 579 8993 5025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026