Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT03365869
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03365869
Study Brief:
Protocol Section:
NCT03365869