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

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Glucocorticoid; Drug: Tofacitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05606107

2022-0159

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

230 participants in 2 patient groups

Glucocorticoid group

Active Comparator group

Treatment:

Drug: Glucocorticoid

Tofacitinib group

Experimental group

Treatment:

Drug: Tofacitinib