Clinical trial NCT05606107: To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis, moderate disease activity, high disease activity
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jiaxing Hospital of T.C.M
name: Jinhua Municipal Central Hospital
name: SAHZU.CHANGXING CAMPUS
name: Zhuji People's hospital
name: Shaoxing People's Hospital
First posted: 2022-11-04
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: DAS28-CRP
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Changxing
country: China
facility: Changxing Country People's Hospital
city: Jiaxing
country: China
facility: Jiaxing Central Hospital
city: Jinhua
country: China
facility: Jinhua Central Hospital
city: Shaoxing
country: China
facility: Shaoxing Central Hospital
city: Zhuji
country: China
facility: Zhuji People's Hospital
Study officials:
References: