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Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

Authors:	Stefan Schreiber Shomron Ben-Horin Jaroslaw Leszczyszyn Robert Dudkowiak Adi Lahat Beata Gawdis-Wojnarska Aldis Pukitis Marek Horynski Katalin Farkas Jaroslaw Kierkus Maciej Kowalski Sang Joon Lee Sung Hyun Kim Jee Hye Suh Mi Rim Kim Seul Gi Lee Byong Duk Ye Walter Reinisch

Institution:	1. Department for Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany;2. Gastroenterology Department, Chaim Sheba Medical Center and Sackler School of Medicine, Tel Aviv University, Tel-Hashomer, Israel;3. Department of Gastroenterology, Melita Medical, Wroclaw, Poland;4. Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Poland;5. Department of Gastroenterology, Twoja Przychodnia—Szczecińskie Centrum Medyczne, Szczecin, Poland;6. Center of Gastroenterology, Hepatology and Nutrition, Pauls Stradins Clinical University Hospital, Riga, Latvia;7. Endoskopia sp. z o.o., Sopot, Poland;8. Department of Clinical Pharmacology, Szent Imre Egyetemi Oktatókórház, Budapest, Hungary;9. Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Children’s Memorial Health Institute, Warsaw, Poland;10. Gastroenterology Department, Centrum Diagnostyczno—Lecznicze Barska sp. z o.o., Wloclawek, Poland;11. Clinical Development Division, Celltrion, Inc., Incheon, Republic of Korea;12. Clinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea;13. Biometrics Department, Celltrion, Inc., Incheon, Republic of Korea;14. Department of Gastroenterology and Inflammatory Bowel Disease Center, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea;15. Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria

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Keywords:	Crohn’s disease CT-P13 Infliximab Subcutaneous Ulcerative Colitis ADA"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"antidrug antibody AE"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"adverse event CD"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"Crohn’s disease CDAI"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"Crohn’s Disease Activity Index CDAI-70"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"decrease of ≥70 points from baseline in Crohn’s Disease Activity Index score CDAI-100"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"decrease of ≥100 points from baseline in Crohn’s Disease Activity Index score CI"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"confidence interval CRP"} {"#name":"keyword" "$":{"id":"kwrd0110"} "$$":[{"#name":"text" "_":"C-reactive protein trough serum concentrations predose serum concentration at Week 22 FC"} {"#name":"keyword" "$":{"id":"kwrd0140"} "$$":[{"#name":"text" "_":"fecal calprotectin IBD"} {"#name":"keyword" "$":{"id":"kwrd0150"} "$$":[{"#name":"text" "_":"inflammatory bowel disease IRR"} {"#name":"keyword" "$":{"id":"kwrd0160"} "$$":[{"#name":"text" "_":"infusion-related reaction ISR"} {"#name":"keyword" "$":{"id":"kwrd0170"} "$$":[{"#name":"text" "_":"injection-site reaction IV"} {"#name":"keyword" "$":{"id":"kwrd0180"} "$$":[{"#name":"text" "_":"intravenous LSM"} {"#name":"keyword" "$":{"id":"kwrd0190"} "$$":[{"#name":"text" "_":"least-squares mean NAb"} {"#name":"keyword" "$":{"id":"kwrd0200"} "$$":[{"#name":"text" "_":"neutralizing antibody q#w"} {"#name":"keyword" "$":{"id":"kwrd0210"} "$$":[{"#name":"text" "_":"every # weeks RA"} {"#name":"keyword" "$":{"id":"kwrd0220"} "$$":[{"#name":"text" "_":"rheumatoid arthritis SC"} {"#name":"keyword" "$":{"id":"kwrd0230"} "$$":[{"#name":"text" "_":"subcutaneous SIBDQ"} {"#name":"keyword" "$":{"id":"kwrd0240"} "$$":[{"#name":"text" "_":"Simplified Inflammatory Bowel Disease Questionnaire SIR"} {"#name":"keyword" "$":{"id":"kwrd0250"} "$$":[{"#name":"text" "_":"systemic injection reaction TEAE"} {"#name":"keyword" "$":{"id":"kwrd0260"} "$$":[{"#name":"text" "_":"treatment-emergent adverse event TESAE"} {"#name":"keyword" "$":{"id":"kwrd0270"} "$$":[{"#name":"text" "_":"treatment-emergent serious adverse event TNF"} {"#name":"keyword" "$":{"id":"kwrd0280"} "$$":[{"#name":"text" "_":"tumor necrosis factor UC"} {"#name":"keyword" "$":{"id":"kwrd0290"} "$$":[{"#name":"text" "_":"ulcerative colitis W"} {"#name":"keyword" "$":{"id":"kwrd0300"} "$$":[{"#name":"text" "_":"week
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