Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meet ACR criteria for diffuse systemic sclerosis
\< 24 months since onset of first SSc manifestation other than Raynaud's phenomenon
Modified Rodnan Skin Score ≥ 15
Male or female adult ( ≥ 18 years of age)
Able and willing to give written informed consent and comply with study protocol
You may not be if
Moderate or severe pulmonary disease w/ FVC \< 80% or DLCO \< 70% or ground glass and fibrosis \> 20% of lung fields by HRCT
Treatment with investigational drug within 4 weeks of screening
Ongoing use of high dose steroids (\> 10mg/day) or unstable steroid dose in past 4 weeks
Treatment with immunosuppressive, cytotoxic, or antifibrotic drug within 4 weeks of screening
Positive for HIV, HBV, and/or HCV
Known active infection (bacterial, viral, fungal, mycobacterial, or other); not including fungal infection of nail beds or any major infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening
Patients w/ history of malignancy or premalignant lesion
History of keratoacanthoma or squamous cell carcinoma
Moderate to severe hepatic impairment
SSc renal crisis within 6 months or creatinine \> 2.0
Lack of IV access for medication administration
Moderate or severe cardiac disease with significant arrhythmia, heart failure, or unstable angina
Anemia (Hb \< 8.5 gm/dL)
Thrombocytopenia or blood clotting disorder
Patients with organ transplant (including allogeneic bone marrow transplant)
Clareo Health | Fresolimumab In Systemic Sclerosis
