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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05606107

Enrollment

230

Registered

2022-11-04

Start date

2022-05-20

Completion date

2024-12-31

Last updated

2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, moderate disease activity, high disease activity

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.

Interventions

DRUGTofacitinib

Tofacitinib combined with other csDMARDs, but no glucocorticoids.

DRUGGlucocorticoid

Glucocorticoid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
DAS28-CRP	24 weeks	Disease activity

Countries

China

Contacts

Primary ContactWu Huaxiang, Doctor

wuhx8855@zju.edu.cn13757118395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026