Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Summary

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

Timeline

Start

2014-03-27

Primary completion

2019-09-05

Completion

2019-11-11

Publications

• Reppell M, Zheng X, Dreher I, Blaes J, Regan E, Haslberger T, Guay H, Pivorunas V, Smaoui N. HLA-DQA1*05 Associates With Anti-Tumor Necrosis Factor Immunogenicity and Low Adalimumab Trough Concentrations in Inflammatory Bowel Disease Patients From the SERENE Ulcerative Colitis and Crohn's Disease Studies. J Crohns Colitis. 2025 Jan 11;19(1):jjae129. doi: 10.1093/ecco-jcc/jjae129.
• Verstockt B, Pivorunas V, Al Mahi N, Smaoui N, Guay H, Kennedy NA, Goodhand JR, Lin S, Bai BYH, Hanauer SB, Ferrante M, Panes J, Vermeire S. Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies. J Crohns Colitis. 2024 Apr 23;18(4):493-505. doi: 10.1093/ecco-jcc/jjad170.
• Ponce-Bobadilla AV, Stodtmann S, Chen MJ, Winzenborg I, Mensing S, Blaes J, Haslberger T, Laplanche L, Dreher I, Mostafa NM. Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis. Clin Pharmacokinet. 2023 Apr;62(4):623-634. doi: 10.1007/s40262-023-01221-x. Epub 2023 Mar 11.
• Greener T, Boland K, Milgrom R, Ben-Bassat O, Steinhart AH, Silverberg MS, Narula N. Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients. Eur J Gastroenterol Hepatol. 2021 Oct 1;33(10):1274-1279. doi: 10.1097/MEG.0000000000002250.

Drugs

Indications