The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04927000
Collaborator
(none)
170
1
2
31
5.5

Study Details

Study Description

Brief Summary

Rheumatoid arthritis (RA) is a systemic chronic arthritis characterized by systemic inflammation, persistent synovitis and final joint destruction Inflammatory diseases can lead to decreased productivity and impaired health-related quality of life. As a chronic disease, rheumatoid Chronic arthritis needs long-term treatment. At the same time, RA can cause skin, eye, lung, liver, kidney, blood and cardiovascular diseases All of them were extraarticular lesions. It causes a heavy burden to the patients themselves, their families and the society. The main clinical manifestations of RA were morning stiffness Joint swelling and pain, cartilage destruction and joint space narrowing, if not treated, will lead to joint destruction, deformity and dysfunction The rate of disability is high. As a new drug in the treatment of RA, tofacitinib can relieve RA symptoms and promote joint healing It can recover the injury and correct the abnormal immune function. At present, studies have proved that the traditional anti rheumatic drugs are ineffective in the treatment of RA. The addition of tofacitinib to patients may be beneficial to the treatment.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Participant inclusion and selection criteria: A total of 170 patients with rheumatoid arthritis were enrolled.

Inclusion criteria: The diagnosis of rheumatoid arthritis of patients must meet the ACR 1987 classification criteria for rheumatoid arthritis, female, aged 30-65 years old, all The patients have been using traditional dMARDs combined with glucocorticoid for 1 month (glucocorticoid dosage 10-15mg/day), and the DAS28 scores are all greater than 3.2, considering that the disease is still active.

Exclusion criteria: Including other connective tissue diseases, neurological diseases, combined depression, ongoing antidepressant treatment, severe cardiovascular disease, latent tuberculosis, tumors, severe liver and kidney dysfunction.

Randomly divided into two groups: tofacitinib treatment group and control group with 85 cases each. The probability of patients being classified into different groups: both are 50%.

Control group: basic dMARDs of all subjects: methotrexate (10mg) combined with [(sulfasalazine (2g/day), isilamod (50mg/day), leflunomide (20mg/day)] One or two of the two. All subjects used glucocorticoids (10-15 mg/day).

Tofacitinib group: combined with tofacitinib 5mg/twice a day on the basis of the above scheme.

All patients will be evaluated once a month for the first three months, including the DAS28 score, serum C-reactive protein, erythrocyte sedimentation rate, liver and kidney function and other serological indicators. After three months, the disease will be evaluated once 1-2 months. The assessment content is the same as above. .

Research endpoints: 1. After treatment, the DAS28 score is less than 2.6, considering the disease remission, gradually reduce the dose to stop the hormone. 2. Hormone use for more than 6 months cannot be reduced or stopped or if the condition worsens, consider adding other dMARDs or biological agents to control the condition. 3. The test needs to be terminated in case of serious adverse reactions. All subjects recorded the time when hormones were stopped and the total amount of hormones used.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis
Actual Study Start Date :
May 31, 2021
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

All subjects used one or two the basic DMARDs: Methotrexate (10mg) combined with sulfasalazine (2G / day), Iguratimod (50 mg / day), leflunomide (20 mg / day)]. All subjects were treated with Glucocorticoid (10-15mg)/Days).

Experimental: Tofacitinib treatment group

All subjects used one or two the basic DMARDs: Methotrexate (10mg) combined with sulfasalazine (2G / day), Iguratimod (50 mg / day), leflunomide (20 mg / day)]. All subjects were treated with Glucocorticoid (10-15mg)/Days). All subjects were treated with Tofacitinib 5mg/BID.

Drug: Tofacitinib
in tofacitinib treatment group,we added tofacitinib 5mg/BID in the basic treatment in all subjects.
Other Names:
  • Xeljanz
  • Outcome Measures

    Primary Outcome Measures

    1. Disease remission of rheumatoid arthritis patients [through study completion,an average of 1 year]

      Disease Activity Score 28 score(DAS28). DAS28>3.2 means disease active,DAS28 <2.6 means disease remission

    2. Disease remission of rheumatoid arthritis patients [through study completion,an average of 1 year]

      Liver and kidney function were measured with a BN ProSpec System. Alanine aminotransferase more than three times of the normal value and eGRF<60 were exclued for further study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Clinical diagnosis of rheumatoid arthritis female gender, 30 to 65 years old, all patients the traditional DMARDs combined with glucocorticoid for 1 month (glucocorticoid dosage 10-15mg/ day) was used, and DAS28 score was large than 3.2, consider that the disease is still active.

    Exclusion Criteria:

    other connective tissue diseases, neurological diseases, major depression, cardiovascular disease, latent tuberculosis, tumor, severe liver and kidney dysfunction.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang China 310009

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04927000
    Other Study ID Numbers:
    • 2020-388
    First Posted:
    Jun 15, 2021
    Last Update Posted:
    Jun 15, 2021
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 15, 2021