TY - JOUR T1 - STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease JF - The Journal of Rheumatology JO - J Rheumatol DO - 10.3899/jrheum.191365 SP - jrheum.191365 AU - Dinesh Khanna AU - Donald P. Tashkin AU - Athol U. Wells AU - James R. Seibold AU - Stephen Wax AU - Cristina Vazquez-Mateo AU - Patricia Fleuranceau-Morel AU - Doris Damian AU - Christopher P. Denton Y1 - 2020/10/01 UR - http://www.jrheum.org/content/early/2020/09/28/jrheum.191365.abstract N2 - Objective To investigate the effects of abituzumab in systemic sclerosis-associated interstitial lung disease (SSc-ILD). Methods STRATUS was a Phase II, double-blind, parallel-group, multicenter trial (NCT02745145). Adults (≤75 years) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, placebo, or abituzumab 500 mg every 4 weeks for 104 weeks. Primary endpoint: annual rate of change in absolute FVC. Results STRATUS was terminated prematurely due to slow enrolment (n=75 screened, n=24 randomized), precluding robust analysis of efficacy. Abituzumab was well-tolerated; no new safety signals were detected. Conclusion Further investigation of abituzumab for treatment of SSc-ILD is required. ER -