A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis
NCT ID: NCT03365869
Last Updated: 2017-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
72 participants
INTERVENTIONAL
2018-06-01
2019-06-30
Brief Summary
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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)).
Detailed Description
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The end points were the changement of modified RSS and the adverse events or severe adverse events onset.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sirolimus
Add sirolimus according to the protocol. Sirolimus active: 2mg po. QD
Sirolimus
Sirolimus or placebo were added to patients every day
placebo
sirolimus placebo: 2mg po. QD
Sirolimus
Sirolimus or placebo were added to patients every day
Interventions
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Sirolimus
Sirolimus or placebo were added to patients every day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Mu Rong, Poster
Role: PRINCIPAL_INVESTIGATOR
Peking University Institute of Rheumatology and Immunology
Central Contacts
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Other Identifiers
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PKUPH-R-SRL
Identifier Type: -
Identifier Source: org_study_id