Crohn's disease
Conditions
Interventions
Trade Name: Humira (adalimumab)
Product Name: Adalimumab
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Radboud University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 or older • Diagnosis of colonic and/or distal ileal CD • Sustained steroid-free clinical remission for >12 months whilst being treated with adalimumab at a stable dose • Adalimumab dosed at 40 mg every 2 weeks • Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment: - Absence of active inflammatory intestinal or extra-intestinal symptoms, as judged by both patient and physician - Fecal calprotectin (FC) =65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: • Absence of written informed consent • Concomitant corticosteroid usage • Need for IBD-related surgery • Actively draining peri-anal fistula • Pregnancy or lactation • Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness) • Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Key objective of this study is to demonstrate non-inferiority of disease activity guided adalimumab injection interval lengthening compared to usual care (continued dosing) in maintaining remission in CD at 48 weeks of follow-up. ;Secondary Objective: - The proportion of patients in remission with interval extension at 48 weeks. - The proportion of persistent flares (persistent flare is defined as >8 weeks HBI increase = 5, FC >250 µg/g and/or CRP >5 mg/L) between the interval extension and usual care groups. - To compare quality of life maintenance between interval extension and usual care groups. - To compare disease activity (HBI) every 3 months during the follow-up of 48 weeks between interval extension and usual care. - To identify factors, which are linked to successful interval extension (e.g. baseline patient and treatment characteristics, FC, CRP, adalimumab trough levels and antibodies to adalimumab). - To compare development of serious adverse events (SAEs) between interval extension and usual care. ;Primary end point(s): Difference in cumulative incidence of persistent exacerbations (>8 weeks) between the dose reduction and usual care groups at 48-week follow-up.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Cumulative incidence of patients with transient flare (duration =8 weeks) • Disease activity measured by Harvey-Bradshaw Index (HBI) and fecal calprotectin (FC) • PROM: PRO-2 (abdominal pain and stool frequency). • Adalimumab trough levels • Anti-adalimumab antibody levels • Adverse event rates (including injection site reactions and infections) • Quality of life (via SIBDQ) • Costs from a health care and societal perspective (via EQ-5D-5L, iMTA PCQ and iMTA MCQ) - (S)AE's ;Timepoint(s) of evaluation of this end point: Patients will be seen every 3 months. | — |
Countries
Netherlands
Contacts
Public ContactFrank Hoentjen
Radboudumc
Outcome results
None listed