| Autor: |
J Jansen, L J T Smits, R W M Pauwels, W Kievit, D J de Jong, A C de Vries, F Hoentjen, C J van der Woude, A.A. van Bodegraven, A.G.L. Bodelier, P.J. Boekema, N. de Boer, P.C.J. ter Borg, A.A. den Broeder, I.A.M Gisbertz, F.M Jansen, S.V. Jansen, D.J. de Jong, W. Kievit, R.C.A. van Linschoten, M Löwenberg, M.W.M.D. Lutgens, R.C. Mallant-Hent, A.E. van der Meulen, B. Oldenburg, R.W.M. Pauwels, M Pierik, M.J.L. Romberg-Camps, T.E.H. Römkens, M.G.V.M. Russel, L.J.T. Smits, A.C.I.T.L. Tan, M.L. Verhulst, A.C. de Vries, R.L. West, F.H.J. Wolfhagen, C.J. van der Woude |
| Jazyk: |
angličtina |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
BMJ Open, Vol 10, Iss 5 (2020) |
| Druh dokumentu: |
article |
| ISSN: |
2044-6055 |
| DOI: |
10.1136/bmjopen-2019-035326 |
| Popis: |
Introduction Adalimumab is effective for maintenance of remission in patients with Crohn’s disease (CD) at a dose of 40 mg subcutaneously every 2 weeks. However, adalimumab is associated with (long-term) adverse events and is costly. The aim of this study is to demonstrate non-inferiority and cost-effectiveness of disease activity guided adalimumab interval lengthening compared to standard dosing of every other week (EOW).Methods and analysis The Lengthening Adalimumab Dosing Interval (LADI) study is a pragmatic, multicentre, open label, randomised controlled non-inferiority trial. Non-inferiority is reached if the difference in cumulative incidence of persistent (>8 weeks) flares does not exceed the non-inferiority margin of 15%. 174 CD patients on adalimumab maintenance therapy in long-term (>9 months) clinical and biochemical remission will be included (C-reactive protein (CRP) 250 µg/g, CRP≥10 mg/l, HBI≥5. Secondary outcomes include cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness.Ethics and dissemination The study is approved by the Medical Ethics Committee Arnhem-Nijmegen, the Netherlands (registration number NL58948.091.16). Results will be published in peer-reviewed journals and presented at international conferences.Trial registration numbers EudraCT registry (2016-003321-42); Clinicaltrials.gov registry (NCT03172377); Dutch trial registry (NTRID6417). |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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