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

Phase 4

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Glucocorticoid; Drug: Tofacitinib

• Registration Number: NCT05606107
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-20
• Status Verified: 2022-10
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucocorticoid group	Glucocorticoid	-
Tofacitinib group	Tofacitinib	-

Primary Outcome Measures

Name	Time	Method
DAS28-CRP	24 weeks	Disease activity

Trial Locations

Locations (5)

Jiaxing Central Hospital; 🇨🇳 Jiaxing, China

Zhuji People's Hospital; 🇨🇳 Zhuji, China

Changxing Country People's Hospital; 🇨🇳 Changxing, China

Jinhua Central Hospital; 🇨🇳 Jinhua, China

Shaoxing Central Hospital; 🇨🇳 Shaoxing, China