The Role of Tofacitinib in Steroid Withdrawal in Rheumatoid Arthritis
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: xuyan U yang, PHD
- Phone Number: +8613819186380
- Email: hangzhouyxy@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recruiting
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Contact:
- Xuyan Yang, PhD
- Phone Number: 13819186380
- Email: hangzhouyxy@zju.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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). |
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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. |
in tofacitinib treatment group，we added tofacitinib 5mg/BID in the basic treatment in all subjects.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease remission of rheumatoid arthritis patients
Time Frame: 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
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through study completion，an average of 1 year
|
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Disease remission of rheumatoid arthritis patients
Time Frame: 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.
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through study completion，an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-388
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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