A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis
A Phase Ⅱ Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis
1 other identifier
interventional
72
0 countries
N/A
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 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)).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2018
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedDecember 7, 2017
December 1, 2017
7 months
December 4, 2017
December 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants whose modified Rodnan skin score （mRSS）decreasing
mRSS was evaluated in 17 sites of skin.
week 48
Secondary Outcomes (1)
The number of adverse event and severe adverse event occured
week 48
Study Arms (2)
Sirolimus
ACTIVE COMPARATORAdd sirolimus according to the protocol. Sirolimus active: 2mg po. QD
placebo
PLACEBO COMPARATORsirolimus placebo: 2mg po. QD
Interventions
Sirolimus or placebo were added to patients every day
Eligibility Criteria
You may qualify if:
- Meet the American College of Rheumatology criteria for the diagnosis of SSc, 2013.
- Disease duration less than 5 years.
- Negative urine pregnancy test
- Written informed consent form
You may not qualify if:
- Diagnosed with localized scleroderma .
- Added with immunosuppressor in one month such as MTX, AZA, CYC.
- Added with anti-fibosis drug in one month.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mu Rong, Poster
Peking University Institute of Rheumatology and Immunology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2017
First Posted
December 7, 2017
Study Start
June 1, 2018
Primary Completion
December 31, 2018
Study Completion
June 30, 2019
Last Updated
December 7, 2017
Record last verified: 2017-12