To assess non-inferiority of extending the adalimumab dosing interval, under strict disease monitoring in CD patients in sustained (>9months) clinical remission, compared to standard care.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: The difference in cumulative incidence of persistent flares
between the dose reduction and usual care groups at 48-week follow-up.
Secondary outcome
Secondary outcomes
• Cumulative incidence of patients with transient flare (duration <8 weeks)
• Disease activity measured by HBI
• 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 (IBDQ and EQ-5D-5L)
• Costs from a health care and societal perspective
• Medication changes during 2 year observational follow-up
Background summary
Adalimumab is both an effective induction and maintenance therapy for Crohn*s
disease (CD). Due to the risk of side effects (infection, infusion reaction)
and high costs, this drug should be used as efficient as possible. Lengthening
the dosing interval has never been investigated in a randomized controlled
trial in CD patients.
Study objective
To assess non-inferiority of extending the adalimumab dosing interval, under
strict disease monitoring in CD patients in sustained (>9months) clinical
remission, compared to standard care.
Study design
Multicenter, randomized controlled, open label non-inferiority trial, with two
treatment arms.
Study burden and risks
In this study patients will have to visit the site every 12 weeks which is
slightly more than the usual 2-3 times per year. This will allow strict
monitoring of disease control and timely intervention in case of flares. In
terms of diagnostics, blood tests/ fecal tests and questionnaires will be
performed 4 times per year. Additionally, patients in both arms will be
interviewed via telephone every 6 weeks in between clinical visits to assess
for symptoms and potential disease activity. The work-up in case of a suspected
disease relapse includes switching back to the prior injection interval. Risk
of intevral extension includes a higher risk of disease flare. It is
anticipated that most patients will enter remission upon subsequent adjusting
the injection interval. Study patients may benefit from reduced exposure to
adalimumab, reduced risk of injection reactions, and potentially less side
effects including risk of infectious complications.
Geert Grooteplein 8
Nijmegen 6525 GA
NL
Geert Grooteplein 8
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Age 18 or older
- Diagnosis of colonic and/or distal ileal CD
- Sustained steroid-free clinical remission for 9 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:
1. Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
2. Fecal calprotectin (FC) lower than 150 µg/g and CRP <10 mg/L
- If endoscopic remission was recently confirmed, FC can be lower than 250 µg/g
3. Harvey Bradshaw Index (HBI) <5
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003321-42-NL |
| ClinicalTrials.gov | NCT03172377 |
| CCMO | NL58948.091.16 |
| OMON | NL-OMON21837 |