NCT05606107

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started May 2022

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

November 1, 2022

Last Update Submit

November 3, 2022

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, moderate disease activity, high disease activity

Outcome Measures

Primary Outcomes (1)

  • DAS28-CRP

    Disease activity

    24 weeks

Study Arms (2)

Glucocorticoid group

ACTIVE COMPARATOR
Drug: Glucocorticoid

Tofacitinib group

EXPERIMENTAL
Drug: Tofacitinib

Interventions

TofacitinibDRUG

Tofacitinib combined with other csDMARDs, but no glucocorticoids.

Tofacitinib group
GlucocorticoidDRUG

Glucocorticoid

Glucocorticoid group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Changxing Country People's Hospital

Changxing, China

RECRUITING

Jiaxing Central Hospital

Jiaxing, China

NOT YET RECRUITING

Jinhua Central Hospital

Jinhua, China

RECRUITING

Shaoxing Central Hospital

Shaoxing, China

RECRUITING

Zhuji People's Hospital

Zhuji, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinibGlucocorticoids

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Wu Huaxiang, Doctor

CONTACT

13757118395wuhx8855@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 4, 2022

Study Start

May 20, 2022

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

November 4, 2022

Record last verified: 2022-10

Locations

CN(5)