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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2024-12-31

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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glucocorticoid group

Group Type ACTIVE_COMPARATOR

Glucocorticoid

Intervention Type DRUG

Glucocorticoid

Tofacitinib group

Group Type EXPERIMENTAL

Tofacitinib

Intervention Type DRUG

Tofacitinib combined with other csDMARDs, but no glucocorticoids.

Interventions

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Tofacitinib

Tofacitinib combined with other csDMARDs, but no glucocorticoids.

Intervention Type DRUG

Glucocorticoid

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No