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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT03438032
Eligibility Criteria:
Inclusion Criteria:
* meet 2013 ACR criteria for diagnosis of SSc
* have radiographic evidence for ILD and a forced vital capacity \<70% on PFT
* have not taken immune suppression in the last 2 months OR have taken a stable dose of mycophenolate mofetil, rituximab, or prednisone less than or equal to 10 mg for at least 6 months
Exclusion Criteria:
* diagnosis of an overlap syndrome, such as lupus or rheumatoid arthritis
* unable to provide informed consent in English
* currently pregnant or nursing
* current smoker or former smoker (greater than 10 pack years)
* leukopenia
* anemia
* comorbidities of uncontrolled congestive heart failure, cancer not in remission, HIV, or chronic liver disease
* known or suspected infection in the past 3 months
* BMI greater than or equal to 30 kg/m2
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03438032
Study Brief:
Protocol Section:
NCT03438032