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

November 3, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Changxing, China
        • Recruiting
        • Changxing Country People's Hospital
        • Contact:
          • Wang yingying
      • Jiaxing, China
        • Not yet recruiting
        • Jiaxing Central Hospital
        • Contact:
          • Wang Hongzhi
      • Jinhua, China
        • Recruiting
        • Jinhua Central Hospital
        • Contact:
          • Du Hongwei
      • Shaoxing, China
        • Recruiting
        • Shaoxing Central Hospital
        • Contact:
          • Hou Tao
      • Zhuji, China
        • Recruiting
        • Zhuji People's Hospital
        • Contact:
          • Guan Ying

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucocorticoid group
Drug: Glucocorticoid
Glucocorticoid
Experimental: Tofacitinib group
Drug: Tofacitinib
Tofacitinib combined with other csDMARDs, but no glucocorticoids.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Jinhua Municipal Central Hospital
Shaoxing People's Hospital
Jiaxing Hospital of T.C.M
SAHZU.CHANGXING CAMPUS
Zhuji People's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0159

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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