Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2022
• Main ID: NCT03172377
• Date of registration: 29/05/2017
• Prospective Registration: No
• Primary sponsor: Radboud University Medical Center
• Public title: Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients LADI
• Scientific title: Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients
• Date of first enrolment: May 3, 2017
• Target sample size: 174
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03172377
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Netherlands

Contacts

• Name: Prof. dr. van der Woude, MD, PhD
• Affiliation: Erasmus Medical Center

• Name: Dr. Hoentjen, MD, PhD
• Affiliation: Radboud University Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 sc 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) < 150 µg/g and C reactive protein (CRP) <10 mg/L

- Harvey Bradshaw Index (HBI) <5

Exclusion Criteria:

- Absence of written informed consent

- Concomitant corticosteroid usage

- Need for CD-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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Crohn Disease in Remission

Intervention(s)

Other: Lengthening adalimumab dosing interval

Primary Outcome(s)

Cumulative incidence of persistent disease flares. [Time Frame: From the date of randomization up to week 48.]

Secondary Outcome(s)

Cumulative incidence of transient disease flares. [Time Frame: From the date of randomization up to week 48.]

The decremental cost effectiveness ratio of this interval lengthening strategy [Time Frame: From the date of randomization up to week 48.]

(Serious) adverse event rate [Time Frame: From the date of randomization up to week 48.]

Whether biochemic FC or CRP are associated with successful interval lengthening [Time Frame: From the date of randomization up to week 48.]

Whether co-medication use is associated with successful interval lengthening [Time Frame: From the date of randomization up to week 48.]

Whether adalimumab drug level is associated with successful interval lengthening [Time Frame: From the date of randomization up to week 48.]

Secondary ID(s)

2016-003321-42

NL58948.091.16

848015002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Erasmus Medical Center