The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04927000
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    in tofacitinib treatment group，we added tofacitinib 5mg/BID in the basic treatment in all subjects.

Study Details

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.

Key Dates

Start date
May 31, 2021
Status verified
Jul 2020
Primary completion
Aug 30, 2022
Completion
Dec 30, 2023

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

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