A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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 sirolimus in SSc.The investigators evaluate the effectiveness and safeness of sirolimus for Systemic Sclerosis by randomized controlled study (sirolimus 2mg/d (N = 36) versus placebo group (N = 36)).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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