Study concept and design: Gottenberg, Ravaud, Le Guern, Sibilia, Dubost, Morel, Sene, Zarnitsky, Furlan, Benessiano, Seror, Mariette.
Acquisition, analysis, or interpretation of data: Gottenberg, Ravaud, Puéchal, Sibilia, Goeb, Larroche, Dubost, Rist, Saraux, Devauchelle-Pensec, Morel, Hayem, Hatron, Pedriger, Sene, Zarnitsky, Batouche, Perrodeau, Seror, Mariette.
Drafting of the manuscript: Gottenberg, Ravaud, Sibilia, Goeb, Sene, Zarnitsky, Perrodeau, Mariette.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Ravaud, Devauchelle-Pensec, Zarnitsky, Perrodeau, Seror.
Obtained funding: Gottenberg, Ravaud, Dubost, Rist, Sene, Zarnitsky, Mariette.
Administrative, technical, or material support: Gottenberg, Ravaud, Puéchal, Goeb, Saraux, Sene, Zarnitsky, Batouche, Furlan, Benessiano, Mariette.
Study supervision: Gottenberg, Sibilia, Goeb, Saraux, Hatron, Pedriger, Sene, Zarnitsky, Batouche, Mariette.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Gottenberg reports receiving grants from Abbvie, Pfizer, and Roche and personal fees from Bristol-Myers Squibb, Merck Sharpe and Dohme, and Pfizer for activities outside the submitted work. Dr Morel reports receiving fees for consulting from Roche for activities outside the submitted work. Dr Seror reports receiving consulting fees from Roche, Bristol-Myers Squibb, and Pfizer, and grants from EULAR and GlaxoSmithKline for research on Sjögren syndrome. Dr Mariette reports receiving fees from Roche, Pfizer, UCB, Bristol-Myers Squibb, and GlaxoSmithKline for activities outside the submitted work and grants from Roche, Pfizer, Bristol-Myers Squibb, GlaxoSmithKline, and Biogen. No other authors reported disclosures.
Funding/Support: The study was sponsored by Assistance Publique-Hôpitaux de Paris, with a grant from the French Ministry of Research (Programme Hospitalier de Recherche Clinique National 2007 P070125). sanofi-aventis provided hydroxychloroquine and placebo.
Role of the Sponsor: None of the funding sources had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Myriem Carrier, MSc, Direction de la Recherche Clinique, Assistance Publique-Hôpitaux de Paris for helping us set up the study; Karine Inamo, MSc, Stanie Gaete, MSc, Cecile Etienne, MSc, Laina N’Diaye, MSc, and Hélène Agostini, MD, Unité de Recherche Clinique Paris-Sud, Le Kremlin Bicêtre, for monitoring the study; Mickael Randrianandrasana, MSc, and Isabelle Pane, MSc, Department of Epidemiology and Public Health, Hotel Dieu Hospital, Paris, for data management; and Virginie Huart, MSc, Centre de Ressources Biologiques of Bichat Hospital, for the storage of blood samples. No one received compensation for his or her contribution to the study.