Research ArticleArticle
STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis–associated Interstitial Lung Disease
Dinesh Khanna, Donald P. Tashkin, Athol U. Wells, James R. Seibold, Stephen Wax, Cristina Vazquez-Mateo, Patricia Fleuranceau-Morel, Doris Damian and Christopher P. Denton
The Journal of Rheumatology October 2020, jrheum.191365; DOI: https://doi.org/10.3899/jrheum.191365
Dinesh Khanna
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
Donald P. Tashkin
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
Athol U. Wells
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
James R. Seibold
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
Stephen Wax
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
Cristina Vazquez-Mateo
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
Patricia Fleuranceau-Morel
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
Doris Damian
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
Christopher P. Denton
The STRATUS study was sponsored by Merck KGaA ( for all study sites residing in countries outside of the USA) or EMD Serono Research and Development Institute Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA ( for study sites residing within the USA). Merck KGaA authors were involved in the study design, collection, analysis, and interpretation of the data, and in the writing of and decision to submit the manuscript. D. Khanna, MD, MS, Professor of Medicine, University of Michigan, Scleroderma Program, Ann Arbor, Michigan, USA; D.P. Tashkin, MD, Distinguished Emeritus Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA; A.U. Wells, MD, Professor of Medicine, Consultant Chest Physician, Royal Brompton Hospital, London, UK; J.R. Seibold, MD, Principal Member, Scleroderma Research Consultants, LLC, Aiken, South Carolina, USA; S. Wax, MD, PhD, Senior Medical Director, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts (at time of study), Head of Clinical Research, Neurogastrx Inc., Woburn, Massachusetts, USA (current); C. Vazquez-Mateo, PhD, Clinical Research Scientist, P. Fleuranceau-Morel, MBMS, PhD, Head of Safety Scientist, D. Damian, PhD, Director, Biostatistics, EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, Massachusetts, USA; C.P. Denton, PhD, FRCP, Professor of Experimental Rheumatology, Royal Free Campus, University College London, London, UK. DK has received consulting fees from Actelion, Acceleron, Arena, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Corbus, Cytori, GSK, Genentech/Roche, Galapagos, Merck, Mitsubishi Tanabi, and UCB; has received grants (to the University of Michigan) as part of investigator-initiated trials from Bayer, Bristol Myers Squibb, and Pfizer; has stock options in Eicos Sciences Inc.; and is an employee of Civi BioPharma Inc. DPT has received consulting fees from EMD Serono, Boehringer-Ingelheim, and Genentech ( funder of the Scleroderma Lung Study III). AUW reports personal fees from Intermune (advisory board and speaker fees), Boehringer Ingelheim (advisory board and speaker fees), Gilead (advisory board fees), MSD (advisory board fees), Roche (advisory board and speaker fees), Bayer (advisory board and speaker fees), and Chiesi (speaker fees). JRS has received consulting fees from Atlantic, Bayer, Boehringer Ingelheim, Blade, Camurus, Corbus, DRG, EMD Serono, Eicos, Eiger, Guidepoint, Indalo, and Mitsubishi; and has stock options in BriaCell and Pacific Therapeutics. SW was an employee of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany) at the time the study was conducted; he is now an employee of Neurogastrx Inc. CVM, PFM, and DD are employees of EMD Serono Inc. (a business of Merck KGaA, Darmstadt, Germany). CPD has received research grants from GlaxoSmithKline, CSF Behring, and Inventiva; and consulting fees from EMD Serono, Roche/Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer- Ingelheim, Corbus, and Bayer. Address correspondence to Dr. D. Khanna, Division of Rheumatology, Department of Internal Medicine, University of Michigan Scleroderma Program, Ann Arbor, MI 48109, USA. Email: khannad@med.umich.edu. Accepted for publication September 18, 2020.
In this issue
The Journal of Rheumatology
Vol. 51, Issue 4
1 Apr 2024
STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis–associated Interstitial Lung Disease
Dinesh Khanna, Donald P. Tashkin, Athol U. Wells, James R. Seibold, Stephen Wax, Cristina Vazquez-Mateo, Patricia Fleuranceau-Morel, Doris Damian, Christopher P. Denton
The Journal of Rheumatology Oct 2020, jrheum.191365; DOI: 10.3899/jrheum.191365
STRATUS: A Phase II Study of Abituzumab in Patients With Systemic Sclerosis–associated Interstitial Lung Disease
Dinesh Khanna, Donald P. Tashkin, Athol U. Wells, James R. Seibold, Stephen Wax, Cristina Vazquez-Mateo, Patricia Fleuranceau-Morel, Doris Damian, Christopher P. Denton
The Journal of Rheumatology Oct 2020, jrheum.191365; DOI: 10.3899/jrheum.191365