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

Shandong University

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Iguratimod; Drug: Pred; Drug: Tofacitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04928066

Tofacitinib-RA QiluH

Details and patient eligibility

About

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.

Full description

Objective: To observe the clinical efficacy and safety of TF combined with/ without IGU for 30 weeks in patients with moderate to severe active RA with different clinical characteristics and subgroups by using a prospective cohort , and to find the best combination scheme of TF.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Tofacitinib (TF)+Iguratimod (IGU)

Experimental group

Description:

Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Treatment:

Drug: Pred

Drug: Tofacitinib

Drug: Iguratimod

Tofacitinib (TF)

Other group

Description:

Drug: Tofacitinib（TF），5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Prednisone （Pred）： 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Treatment:

Drug: Pred

Drug: Tofacitinib