ARTHRITIS & RHEUMATISM Vol. 60, No. 8, August 2009, pp 2272–2283 DOI 10.1002/art.24638 © 2009, American College of Rheumatology Golimumab, a Human Anti–Tumor Necrosis Factor  Monoclonal Antibody, Injected Subcutaneously Every Four Weeks in Methotrexate-Naive Patients With Active Rheumatoid Arthritis Twenty-Four–Week Results of a Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Golimumab Before Methotrexate as First-Line Therapy for Early-Onset Rheumatoid Arthritis Paul Emery, 1 Roy M. Fleischmann, 2 Larry W. Moreland, 3 Elizabeth C. Hsia, 4 Ingrid Strusberg, 5 Patrick Durez, 6 Peter Nash, 7 Eric Jason B. Amante, 8 Melvin Churchill, 9 Won Park, 10 Bernardo Antonio Pons-Estel, 11 Mittie K. Doyle, 4 Sudha Visvanathan, 12 Weichun Xu, 12 and Mahboob U. Rahman 4 Objective. To assess the safety and efficacy of golimumab in methotrexate (MTX)–naive patients with active rheumatoid arthritis (RA). Methods. MTX-naive patients with RA (n  637) were randomized to receive placebo plus MTX (group 1), golimumab 100 mg plus placebo (group 2), goli- mumab 50 mg plus MTX (group 3), or golimumab 100 mg plus MTX (group 4). Subcutaneous injections of golimumab or placebo were administered every 4 weeks. The dosage of MTX/placebo capsules started at 10 mg/week and escalated to 20 mg/week. The primary end point, the proportion of patients meeting the American College of Rheumatology 50% improvement criteria EudraCT Database no. 2004-003295-10. Supported by Centocor Research and Development (a sub- sidiary of Johnson & Johnson) and Schering-Plough Research Insti- tute. 1 Paul Emery, MA, MD, FRCP: University of Leeds, Leeds, UK; 2 Roy M. Fleischmann, MD: University of Texas Southwestern Medical Center at Dallas; 3 Larry W. Moreland, MD: University of Pittsburgh, Pittsburgh, Pennsylvania; 4 Elizabeth C. Hsia, MD, MSCE, Mittie K. Doyle, MD, Mahboob U. Rahman, MD, PhD: Centocor Research and Development, Malvern, Pennsylvania, and University of Pennsylvania School of Medicine, Philadelphia; 5 Ingrid Strusberg, MD, PhD: Centro Reumatolo ´gico Strusberg, Cordoba, Argentina; 6 Patrick Durez, MD: Universite ´ Catholique de Louvain, Brussels, Belgium; 7 Peter Nash, MBBS (Hons), FRACP: University of Queens- land, Brisbane, Queensland, Australia; 8 Eric Jason B. Amante, MD, FPCP, FPRA: University of the Philippines–Philippine General Hos- pital, Manila, Philippines; 9 Melvin Churchill, MD: Arthritis Center of Nebraska, Lincoln; 10 Won Park, MD, PhD: Inha University Hospital, Incheon, South Korea; 11 Bernardo Antonio Pons-Estel, MD: Sanato- rio Parque, Santa Fe, Argentina; 12 Sudha Visvanathan, PhD, Weichun Xu, PhD: Centocor Research and Development, Malvern, Pennsylva- nia. Dr. Emery has received consulting fees and/or honoraria from Centocor (less than $10,000) and has served as a study investigator for Centocor. Dr. Fleischmann has received consulting fees from Abbott, Wyeth, Amgen, Centocor, Genentech, Pfizer, Astra-Zeneca, UCB, and Roche (less than $10,000 each), has received speaking fees from Abbott, Wyeth, Amgen, Genentech, and Roche (less than $10,000 each), and has served as a study investigator for Abbott, Wyeth, Amgen, Centocor, Genentech, Pfizer, UCB, and Roche. Dr. Moreland has received consulting fees, speaking fees, and/or honoraria from Centocor and Johnson & Johnson (less than $10,000 each) and has served as a study investigator for Centocor. Dr. Hsia owns stock or stock options in Centocor/Johnson & Johnson. Dr. Strusberg has received consulting fees, speaking fees, and/or honoraria from Schering-Plough and Bristol-Myers Squibb (less than $10,000 each). Dr. Durez has received consulting fees, speaking fees, and/or hono- raria from Centocor, Bristol-Myers Squibb, Abbott, and Roche (less than $10,000 each). Dr. Nash has received consulting fees and speaking fees from Schering-Plough (less than $10,000 each) and has served as a study investigator for Centocor. Dr. Amante has received speaking fees from Pfizer, Roche, Schering-Plough, Johnson & Johnson, and Merck, Sharp, and Dohme (less than $10,000 each). Dr. Doyle owns stock or stock options in Centocor/Johnson & Johnson. Dr. Vis- vanathan owns stock or stock options in Johnson & Johnson. Dr. Rahman owns stock or stock options in Johnson & Johnson. Address correspondence and reprint requests to Paul Emery, MA, MD, FRCP, Academic Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. E-mail: p.emery@leeds.ac.uk. Submitted for publication June 24, 2008; accepted in revised form April 1, 2009. 2272