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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606107
• Other study ID #: 2022-0159
• Status: Recruiting
• Phase: Phase 4
• Start date: May 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wu Huaxiang, Doctor
• Phone: 13757118395
• Email: wuhx8855[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tofacitinib
Tofacitinib combined with other csDMARDs, but no glucocorticoids.
• Glucocorticoid
Glucocorticoid

Locations

Country	Name	City	State
China	Changxing Country People's Hospital	Changxing
China	Jiaxing Central Hospital	Jiaxing
China	Jinhua Central Hospital	Jinhua
China	Shaoxing Central Hospital	Shaoxing
China	Zhuji People's Hospital	Zhuji

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Jiaxing Hospital of T.C.M, Jinhua Municipal Central Hospital, SAHZU.CHANGXING CAMPUS, Shaoxing People's Hospital, Zhuji People's hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28-CRP	Disease activity	24 weeks