Status:
UNKNOWN
Iguratimod in Systemic Sclerosis
Lead Sponsor:
RenJi Hospital
Conditions:
Systemic Sclerosis, Diffuse
Eligibility:
All Genders
19-74 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.
Eligibility Criteria
Inclusion
- Diagnosis of systemic sclerosis (SSc), as classified using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
- Diffuse Cutaneous Systemic Sclerosis (dcSSc) as defined by 2001 LeRoy and Medsger Disease duration ≤ 3 years (defined as time from the first non-Raynaud phenomenon manifestation).
- Agree to use effective contraception during the study period (women of childbearing age).
- Smokers agreed to quit smoking during the study.
- Ability to provide informed consent.
Exclusion
- The following drugs have been used within one month before screening: including TNF-α inhibitors (continuous use for more than 14 days), IL-6 inhibitors, abatacept (continuous use for more than 14 days), JAK inhibitors (continuous use for more than 14 days).
- Used rituximab within 3 months before screening.
- SSc with tumor.
- People with various lung infections, asthma or other lung diseases such as bronchiectasis.
- For patients with severe heart, liver, kidney and other important organ dysfunction, the evaluation criteria are as follows: ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin rises twice; CPK\>400; Renal crisis, or hypertension of various causes (≥160/100mmHg) is not controlled; Creatinine clearance rate \<30ml/min; White blood cell count\<3×109/L; Hemoglobin \<80g/L; Platelet count\<60×109/L; Heart function level III-IV; PaO2\<50mmHg in resting state; FEV1/FVC\<0.7.
- In the period of acute or chronic infection (not including finger ulcer combined infection).
- A history of peptic ulcer or bleeding within 6 months before screening.
- People with allergies or multiple drug allergies.
- People with mental illness or other reasons who cannot cooperate with treatment.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04515706
Start Date
January 1 2021
End Date
January 31 2024
Last Update
August 17 2020
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