Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease

Summary

The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein \[hs-CRP\] and fecal calprotectin), and corticosteroid use, improves the rate of mucosal healing 48 weeks after randomization compared with management using less stringent criteria based only on CDAI and corticosteroid use.

Timeline

Start

2011-02-11

Primary completion

2016-11-03

Completion

2017-01-03

Outcome

Met primary endpoint

paper A significantly higher proportion of patients in the tight control group achieved the primary endpoint at week 48 (56 [46%] of 122 patients) PMID 29096949 ↗

registry analysis (superiority test); Clinically Driven Management vs Tight Control Management; p = 0.010; Cochran-Mantel-Haenszel NCT01235689 ↗

Publications

• Lakatos PL, Kaplan GG, Bressler B, Khanna R, Targownik L, Jones J, Rahal Y, McHugh K, Panaccione R. Cost-Effectiveness of Tight Control for Crohn's Disease With Adalimumab-Based Treatment: Economic Evaluation of the CALM Trial From a Canadian Perspective. J Can Assoc Gastroenterol. 2022 Mar 10;5(4):169-176. doi: 10.1093/jcag/gwac001. eCollection 2022 Aug.
• Ungaro RC, Yzet C, Bossuyt P, Baert FJ, Vanasek T, D'Haens GR, Joustra VW, Panaccione R, Novacek G, Reinisch W, Armuzzi A, Golovchenko O, Prymak O, Goldis A, Travis SP, Hebuterne X, Ferrante M, Rogler G, Fumery M, Danese S, Rydzewska G, Pariente B, Hertervig E, Stanciu C, Serrero M, Diculescu M, Peyrin-Biroulet L, Laharie D, Wright JP, Gomollon F, Gubonina I, Schreiber S, Motoya S, Hellstrom PM, Halfvarson J, Butler JW, Petersson J, Petralia F, Colombel JF. Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease. Gastroenterology. 2020 Jul;159(1):139-147. doi: 10.1053/j.gastro.2020.03.039. Epub 2020 Mar 26.
• Panaccione R, Colombel JF, Travis SPL, Bossuyt P, Baert F, Vanasek T, Danalioglu A, Novacek G, Armuzzi A, Reinisch W, Johnson S, Buessing M, Neimark E, Petersson J, Lee WJ, D'Haens GR. Tight control for Crohn's disease with adalimumab-based treatment is cost-effective: an economic assessment of the CALM trial. Gut. 2020 Apr;69(4):658-664. doi: 10.1136/gutjnl-2019-318256. Epub 2019 Jul 8.
• Colombel JF, Panaccione R, Bossuyt P, Lukas M, Baert F, Vanasek T, Danalioglu A, Novacek G, Armuzzi A, Hebuterne X, Travis S, Danese S, Reinisch W, Sandborn WJ, Rutgeerts P, Hommes D, Schreiber S, Neimark E, Huang B, Zhou Q, Mendez P, Petersson J, Wallace K, Robinson AM, Thakkar RB, D'Haens G. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2017 Dec 23;390(10114):2779-2789. doi: 10.1016/S0140-6736(17)32641-7. Epub 2017 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Azathioprine	Small molecule	1.25 mg/kg	Oral
Subject	Azathioprine	Small molecule	2.5 mg/kg	Oral
Subject	Prednisone	Other / unclassified	40 mg	Oral

Indications