Clinical Trials & Translational Studies in Scleroderma

Actively Recruiting Clinical Trials
Study name	Indication	Principal Investigator	Study Contact	Email/Phone
PIONEER – Pilot study of Genomic Profiles of scleroderma-PAH patients treated with Adcirca (Tadalafil)	Scleroderma-PAH patients who are not on PDEI	Harrison Farber, MD	Fei-Ying Cheong	fycheong@bu.edu 617.638.4344
Scleroderma Lung Study II (SLS II)	Limited & Diffuse SSc	Robert Simms, MD Harrison Farber, MD	Fei-Ying Cheong	fycheong@bu.edu 617.638.4344
DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Diffuse & Limited SSc	Robert Simms, MD	Fei-Ying Cheong	fycheong@bu.edu 617.638.4344
Rilonacept- Randomized, Double-Blind, Placebo-Controlled Trial of IL1-TRAP – A Phase I/II Biomarker Trial	Diffuse SSc	Robert Lafyatis, MD	Cristina Padilla	cpadilla@bu.edu 617.638.5965

Upcoming Clinical Trials
Fresolimumab (Anti-TGF-β) – IV Study Medication w/ Skin Biopsies for Diffuse Scleroderma	Diffuse SSc	Robert Lafyatis, MD	Cristina Padilla	cpadilla@bu.edu 617.638.5965
Tocilizumab- A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients with Systemic Sclerosis (Approximate start date: 02/2012)	Diffuse SSc	Robert Lafyatis, MD	Sarah McLaughlin	srm29@bu.edu 617.638.5965
Pomalidomide in Diffuse SSc with ILD	Diffuse SSc with ILD	Robert Simms, MD	Fei-Ying Cheong	fycheong@bu.edu

Actively Recruiting Translational Studies
Biomarkers in Scleroderma (Observational- yearly visits)	SSc	Robert Lafyatis, MD	Cristina Padilla Sarah McLaughlin	cpadilla@bu.edu srm@bu.edu
Fibroblast and Immune Cell Culture From Skin	Diffuse SSc	Robert Lafyatis, MD	Cristina Padilla	cpadilla@bu.edu 617.638.5965

Upcoming Translational Studies
CORT Biomarker Study	SSc	Robert Lafyatis, MD	Cristina Padilla Sarah McLaughlin	cpadilla@bu.edu srm29@bu.edu