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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    100
  • sponsor
    Qilu Hospital of Shandong University
Updated on 26 June 2021
tofacitinib
autoimmune disease

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.

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.

Details
Condition Rheumatoid Arthritis
Treatment tofacitinib, Iguratimod, Pred
Clinical Study IdentifierNCT04928066
SponsorQilu Hospital of Shandong University
Last Modified on26 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who meet the following inclusion criteria will be eligible to
participate in the
study
Patients who meet RA standards in 1987 and 2010 or ERA standards in 2012
Age > 18 years old
the extrapulmonary manifestations of RA were stable
Patients with NSAIDs tolerance
DAS28-ESR is highergreater than 2.6

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the
study
Patients with acute and chronic infection
Platelet count < 80 _10^9/L, or white blood cell < 3_10^9/L
ALT or AST is 2 times higher than the upper limit of normal value
Renal insufficiency: serum Cr 176 umol/L
Pregnant or lactating women (breastfeeding)
Have a history of malignant tumor (the cure time is less than 5 years)
Patients with severe hypertension and cardiac insufficiency
Other diseases or conditions in which immune suppressants cannot be used
People who are allergic to TF
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