A Phase 2 interventional study of Sirolimus in Systemic Sclerosis, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-07.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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)).
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 adverse events or severe adverse events onset.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 72 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Add sirolimus according to the protocol. Sirolimus active: 2mg po. QD
Drug: Sirolimus
sirolimus placebo: 2mg po. QD
Drug: Sirolimus
Sirolimus or placebo were added to patients every day
Also known as: placebo
Number of participants whose modified Rodnan skin score （mRSS）decreasing
mRSS was evaluated in 17 sites of skin.
Time frame: week 48
The number of adverse event and severe adverse event occured
SAE were recorded as life-threatening and others were AE.
Time frame: week 48
No study locations are listed for this record.
Start is estimated for Jun 2018; primary completion for Dec 2018, 6 months later.
Of 48 phase 2 interventional studies under Scleroderma, Systemic, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 83. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sirolimus
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