OBJECTIVES: Severe Crohn’s disease management includes anti-Tumour Necrosis Factor (anti-TNF) drugs. These drugs differ from the treatments used in early stages of the disease in terms of efficacy, safety and convenience. This can modify the impact of the disease and its treatment on patients’ lives. The objective of the study was to develop a questionnaire assessing patients’ satisfaction with anti-TNF treatments in Crohn’s disease. METHODS: A literature review, 3 clinician interviews and 3 interviews with nurses were carried out as a preparation step. Semi-directive patient interviews (16) were then conducted using a specific interview guide. Transcripts were analysed using thematic analysis to extract concepts related to satisfaction with treatments and to organise them into a model. Items were generated for each concept of interest using patients’ words. The resulting test version of the questionnaire was tested for relevance and comprehension with 7 patients and revised accordingly; the new version was tested on a second set of 5 patients and revised to provide the pilot version. A clinician advisory board was involved at each milestone of the questionnaire development for validation. RESULTS: The test questionnaire assessed treatment satisfaction through 49 questions and 67 items, organised into 5 sections: treatment efficacy, side-effects, convenience and constraints, global impact, and satisfaction. Conceptual content of the questionnaire includes comparison to prior state and to expectations, satisfaction, acceptability, and intentions. The questionnaire was globally well-accepted by patients during the tests; few modifications were made in the structure and some items were reformulated. The pilot version (62 items) was finalised after the second round of comprehension tests. CONCLUSIONS: The questionnaire is a unique tool to assess treatment satisfaction in patients with severe Crohn’s disease treated by anti-TNF. A scoring and validation study is currently being completed before the questionnaire can be included in clinical research and epidemiological studies.