The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

RA is a common autoimmune disease that causes joint damage.It is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. Tofacitinib(TF) is a new type of oral tyrosine kinase inhibitor (JAKi) for the treatment of moderate to severe active RA. However, there is alack of Chinese data on the joint scheme, long-term use, maintenance and stop of TF in the real world. We will use the new JAK combination regimen to treat RA patients, and carry out long-term clinical follow-up for 30 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Hospital of Shandong University
• Treatments: Prednisone; Tofacitinib

Criteria

Inclusion Criteria:

Patients who meet the following inclusion criteria will be eligible to participate in the study:

1. Patients who meet RA standards in 1987 and 2010 or ERA standards in 2012;

2. Age > 18 years old;

3. the extrapulmonary manifestations of RA were stable;

4. Patients with NSAIDs tolerance;

5. DAS28-ESR is highergreater than 2.6.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Patients with acute and chronic infection;

2. Platelet count < 80*10^9/L, or white blood cell < 3*10^9/L;

3. ALT or AST is 2 times higher than the upper limit of normal value;

4. Renal insufficiency: serum Cr ≥ 176 umol/L;

5. Pregnant or lactating women (breastfeeding);

6. Have a history of malignant tumor (the cure time is less than 5 years);

7. Patients with severe hypertension and cardiac insufficiency;

8. Other diseases or conditions in which immune suppressants cannot be used;

9. People who are allergic to TF.