The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis

NCT04927000 | Unknown Phase 4

• 1 other identifier: 2020-388
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; tofacitinib; dsease remission

Outcome Measures

Primary Outcomes (2)

• Disease remission of rheumatoid arthritis patients

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

  through study completion，an average of 1 year

• Disease remission of rheumatoid arthritis patients

  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.

  through study completion，an average of 1 year

Study Arms (2)

control group

NO INTERVENTION

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).

Tofacitinib treatment group

EXPERIMENTAL

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

Interventions

Tofacitinib DRUG

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

Also known as: Xeljanz

Tofacitinib treatment group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

xuyan U yang, PHD

CONTACT

+8613819186380; hangzhouyxy@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 15, 2021
• Study Start: May 31, 2021
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 15, 2021

Record last verified: 2020-07

Locations

CN (1)