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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT00043706
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of diffuse systemic sclerosis
* Duration of disease 18 months or less
* Modified Rodnan Skin Score in a range as identified by the study protocol
* Evidence of worsening disease activity
* Ability to attend follow-up assessments for a minimum of 9 months
* Agree to delay elective surgery during the trial and up to 9 months after final infusion
* Agree to delay reproduction during the trial and up to 9 months after final infusion
Exclusion Criteria:
* Women who are pregnant or lactating
* Clinical evidence of other definable connective tissue or autoimmune disease
* Severe kidney, heart, lung, or gastrointestinal disease
* Treatment with protocol-specified immunosuppressants within 4 weeks of starting the clinical study
* Treatment with systemic corticosteroids in a dose greater than 10 mg/day of prednisone or equivalent (inhaled steroids at standard doses are allowed)
* Current treatment by photopheresis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00043706
Study Brief:
Protocol Section:
NCT00043706