Overview

To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks

Status:
Recruiting

Trial end date:
2024-12-31

Target enrollment:
0

Participant gender:
All

Summary

Glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects. Tofacitinib is a new small-molecule drug targeting JAK, which has been found to act quickly. The aim of this clinical trial was to investigate the efficacy and safety of tofacitinib and low-dose glucocorticoids in inducing remission in patients with rheumatoid arthritis with moderate to high disease activity.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators:

Jiaxing Hospital of T.C.M
Jinhua Municipal Central Hospital
SAHZU.CHANGXING CAMPUS
Shaoxing People's Hospital
Zhuji People's hospital

Treatments:

Glucocorticoids
Tofacitinib

Criteria

Inclusion Criteria:

1. Age 18-70 years;

2. met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was
diagnosed as RA;

3. After more than 3 months of initial treatment or conventional DMARDs treatment, the
disease was still in medium-high disease activity, and DAS28-CRP>3.2;

4. No birth plan during and within 3 months after the end of the study;

5. Voluntarily sign the informed consent form.

Exclusion Criteria:

1. Patients who are using or have used glucocorticoids, tofacitib and biological agents
in the past 3 months;

2. At the time of screening, patients were in the acute phase of acute infection or
chronic infection;

3. Laboratory test results: Hb<100g/L; White blood cell count <4.0×10^9/L; Platelets
<100×10^9/L; Liver function (transaminase, bilirubin)> 2 times the upper limit of
normal value; Renal function (SCr) > the upper limit of normal;

4. Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal
ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past
three months;

5. A history of severe cardiovascular, cerebrovascular, kidney and other important
organs, blood and endocrine system lesions, malignant tumors and thrombosis;

6. suffering from serious, progressive and uncontrolled diseases of other important
organs and systems;

7. mental disease patients;

8. Other conditions deemed unsuitable for trial participation by the investigator;

9. Pregnancy tests of women of childbearing age were positive.