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

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tofacitinib
Glucocorticoid
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, moderate disease activity, high disease activity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-70 years; met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was diagnosed as RA; 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; No birth plan during and within 3 months after the end of the study; Voluntarily sign the informed consent form. Exclusion Criteria: Patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months; At the time of screening, patients were in the acute phase of acute infection or chronic infection; 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; Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months; A history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis; suffering from serious, progressive and uncontrolled diseases of other important organs and systems; mental disease patients; Other conditions deemed unsuitable for trial participation by the investigator; Pregnancy tests of women of childbearing age were positive.

Sites / Locations

  • Changxing Country People's HospitalRecruiting
  • Jiaxing Central Hospital
  • Jinhua Central HospitalRecruiting
  • Shaoxing Central HospitalRecruiting
  • Zhuji People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Glucocorticoid group

Tofacitinib group

Arm Description

Outcomes

Primary Outcome Measures

DAS28-CRP
Disease activity

Secondary Outcome Measures

Full Information

First Posted
November 1, 2022
Last Updated
November 3, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jiaxing Hospital of T.C.M, Jinhua Municipal Central Hospital, SAHZU.CHANGXING CAMPUS, Zhuji People's hospital, Shaoxing People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05606107
Brief 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
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jiaxing Hospital of T.C.M, Jinhua Municipal Central Hospital, SAHZU.CHANGXING CAMPUS, Zhuji People's hospital, Shaoxing People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, moderate disease activity, high disease activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glucocorticoid group
Arm Type
Active Comparator
Arm Title
Tofacitinib group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Intervention Description
Tofacitinib combined with other csDMARDs, but no glucocorticoids.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid
Intervention Description
Glucocorticoid
Primary Outcome Measure Information:
Title
DAS28-CRP
Description
Disease activity
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-70 years; met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was diagnosed as RA; 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; No birth plan during and within 3 months after the end of the study; Voluntarily sign the informed consent form. Exclusion Criteria: Patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months; At the time of screening, patients were in the acute phase of acute infection or chronic infection; 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; Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months; A history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis; suffering from serious, progressive and uncontrolled diseases of other important organs and systems; mental disease patients; Other conditions deemed unsuitable for trial participation by the investigator; Pregnancy tests of women of childbearing age were positive.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Huaxiang, Doctor
Phone
13757118395
Email
wuhx8855@zju.edu.cn
Facility Information:
Facility Name
Changxing Country People's Hospital
City
Changxing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang yingying
Facility Name
Jiaxing Central Hospital
City
Jiaxing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Hongzhi
Facility Name
Jinhua Central Hospital
City
Jinhua
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Du Hongwei
Facility Name
Shaoxing Central Hospital
City
Shaoxing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hou Tao
Facility Name
Zhuji People's Hospital
City
Zhuji
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guan Ying

12. IPD Sharing Statement

Learn more about this trial

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

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