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

NCT ID: NCT04928066

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-07-30

Brief 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.

Detailed 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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tofacitinib (TF)+Iguratimod (IGU)

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.

Group Type: EXPERIMENTAL

Iguratimod

Intervention Type: DRUG

Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Tofacitinib

Intervention Type: DRUG

Tofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Pred

Intervention Type: DRUG

Pred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Tofacitinib (TF)

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.

Group Type: OTHER

Tofacitinib

Intervention Type: DRUG

Tofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Pred

Intervention Type: DRUG

Pred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Interventions

Iguratimod

Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Intervention Type: DRUG

Tofacitinib

Tofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Intervention Type: DRUG

Pred

Pred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.

Intervention Type: DRUG

Other Intervention Names

IGU; T-614; TF; Prednisone

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qiang Shu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoyun Yang, Dr.

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

Tofacitinib-RA QiluH

Identifier Type: -

Identifier Source: org_study_id