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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT05149768
Eligibility Criteria:
Inclusion Criteria:
1. Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and:
2. Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).
3. Able to give informed consent.
Exclusion Criteria:
1. Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
2. Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
3. Clinically significant pulmonary hypertension requiring drug therapy.
4. Clinically significant cardiac disease.
5. Chronic or ongoing active infectious disease requiring systemic treatment.
6. Seropositivity for human immunodeficiency virus (HIV).
7. Active tuberculosis (TB) infection.
8. Active viral infection with viral replication of hepatitis B or C virus.
9. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.
10. Peripheral neuropathy at screening Grade 2 or higher.
11. Known or suspected hypersensitivity to components of the treatment
12. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
13. Any of the following laboratory abnormalities at screening:
* Absolute neutrophils count \<2.0 x 109/L
* Hemoglobin \<85 g/L
* Platelet count \< 100 x 109/L
* AST/SGOT or ALT/SGPT \>2.0 UNL
14. Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708.
15. Use of rituximab within the previous 4 months.
16. Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit.
17. Current or history of progressive multifocal leukoencephalopathy (PML).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05149768
Study Brief:
Protocol Section:
NCT05149768