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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Tofacitinib
* Drug: Glucocorticoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years; met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was diagnosed as RA; 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; No birth plan during and within 3 months after the end of the study; Voluntarily sign the informed consent form. Exclusion Criteria: Patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months; At the time of screening, patients were in the acute phase of acute infection or chronic infection; 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; Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months; A history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis; suffering from serious, progressive and uncontrolled diseases of other important organs and systems; mental disease patients; Other conditions deemed unsuitable for trial participation by the investigator; Pregnancy tests of women of childbearing age were positive.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucocorticoid group<br> | Drug: Glucocorticoid<br>* Glucocorticoid<br>|
| Experimental: Tofacitinib group<br> | Drug: Tofacitinib<br>* Tofacitinib combined with other csDMARDs, but no glucocorticoids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28-CRP | Disease activity | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, moderate disease activity, high disease activity