Adalimumab for Crohn's disease

Inclusion criteria

• {"criterion_text":"- Newly diagnosed CD patients or CD patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres\n- CD diagnosis according to ECCO-guidelines + complete ileocolonoscopy (last endoscopy performed <12 months before screening) + complete small bowel imaging at diagnosis (MRI or CT-enterography)\n- Naïve to biologicals\n- 18 years old ≤ 70 years old\n- Sufficient knowledge of Dutch language\n- Smartphone with internet access\n- Use of myIBDcoach or willingness to start using myIBDcoach"}

Exclusion criteria

• {"criterion_text":"- Use of prednisone for longer than 4 weeks in the year before screening\n- Use of thiopurines in the 3 years before screening\n- Indication for primary treatment with biologicals or surgery\n- Patients with short bowel syndrome or an ostomy\n- Malignancy in the 5 years before screening. Exception is adequately treated nonmelanoma skin cancer\n- Contra-indication for TNF-blockers or immunosuppressive agents (Contraindications are: a symptomatic stricture, an abscess, a history of tuberculosis or other granulomatous infection, a positive chest radiograph or Quantiferon or tuberculin skin test with purified protein derivative, a recent history of an opportunistic infection (within the previous 6 months), active infection with hepatitis B or C, infection with the human immunodeficiency virus, multiple sclerosis or cancer (except adequately treated non melanoma skin cancer))\n- Contra-indication for MRI- and CT-enterography\n- Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the difference in number of yearly-quarters of corticosteroid free clinical and biochemical remission at week 96. Safety outcomes are disease progression at week 96, drug related adverse events and disease related serious adverse events (hospitalisations, surgery).","definition_or_measurement_approach":"Difference in number of yearly-quarters of corticosteroid-free clinical and biochemical remission at week 96; safety outcomes include disease progression at week 96, drug-related adverse events and disease-related serious adverse events (hospitalisations, surgery)."}

Secondary endpoints

• {"endpoint_text":"- The secondary outcomes are total health care costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, drug-related side effects and patient reported outcome measures on quality of life, (work) disability and treatment-tolerability.","definition_or_measurement_approach":"Includes measurement of total health care costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, drug-related side effects, and patient-reported outcome measures on quality of life, (work) disability and treatment tolerability."}

Netherlands

Earliest CTIS Part Ii Submission Date

13-12-2024

Latest Decision Or Authorization Date

17-12-2024

Processing Time Days

4

Number Of Sites

1

Number Of Participants

158

Primary sponsor

Full Name

Universiteit Maastricht

Organisation Type

Educational Institution

Country Of Registered Address

Netherlands