Status:
UNKNOWN
A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis
Lead Sponsor:
Peking University People's Hospital
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to examine the safety and effectiveness of sirolimus treatment for people with systemic sclerosis. The investigators perform a multi-centre, double-blind pilot trial with ...
Detailed Description
Each SSc patients (n=72) received sirolimus or placebo (active group: placebo group =1:1, 2mg/day， oral administration, (SIR 2mg, po., Qd) . The end points were the changement of modified RSS and the...
Eligibility Criteria
Inclusion
- Meet the American College of Rheumatology criteria for the diagnosis of SSc, 2013.
- Disease duration less than 5 years.
- mRSS was under stable level (\>1 month) at the time inclusion.
- Negative urine pregnancy test
- Written informed consent form
Exclusion
- Diagnosed with localized scleroderma .
- Added with immunosuppressor in one month such as MTX, AZA, CYC.
- Added with anti-fibosis drug in one month.
- Prednisone \>10mg QD before inclusion.
- Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N) )
- Serious infection such as bacteremia, sepsis
- Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma)
- Positive HIV test
- Positive urine pregnancy test
- Combined with the other connective tissue diseases
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03365869
Start Date
June 1 2018
End Date
June 30 2019
Last Update
December 7 2017
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