Last reviewed · How we verify
Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients (LADI)
Crohn's disease is a chronic inflammatory bowel disease. This disease can be treated with, among other things, biologicals such as adalimumab. Patients use adalimumab for a long time to maintain remission and to prevent relapse of the bowel inflammation. The disadvantages of this therapy are the high price and side effects (such as the higher risk of infection). Currently, adalimumab is given every 2 weeks, by injection under the skin. The optimal time between two injections has never been investigated before. Prior research in patients with rheumatoid arthritis shows that disease remission can be maintained with longer injection-intervals. Our hypothesis is that this is the same for Crohn's disease patients. Our aim is to show non-inferiority of extending the adalimumab dosing interval, under strict disease monitoring in Crohn's disease patients in sustained (\>9 months) clinical remission, compared to standard care. During the trial,174 patients with stable Crohn's disease will be divided into 2 groups. One group continues adalimumab injections with the same 2-week interval. And the other group will incrementally extend the interval to 4 weeks, under strict disease monitoring. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval. Thus, we will investigate whether, and for whom, it is safe to extend the adalimumab injection interval.
Details
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 174 |
| Start date | 2017-05-03 |
| Completion | 2022-10 |
Conditions
- Crohn Disease in Remission
- Crohn Disease
Interventions
- Lengthening adalimumab dosing interval
Primary outcomes
- Cumulative incidence of persistent disease flares. — From the date of randomization up to week 48.
A persistent flare is defined as two of three of the following criteria persisting for \> 8 weeks, despite dose escalation of adalimumab; FC \>250 µg/g, CRP≥10 mg/L, HBI ≥5. Non-inferiority is reached if the difference in cumulative incidence of persistent flares not exceeds the non-inferiority margin of 15%.
Countries
Netherlands