ADALIMUMAB for Crohn's disease | Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Aged 12-25 years\n- Diagnosed with luminal Crohn’s disease or ulcerative colitis\n- Treated with either 8-weekly infliximab or 2-weekly adalimumab\n- Current anti-TNF agent as first ever anti-TNF agent or prior anti-TNF agent discontinued for reason other than primary non-response or secondary loss-of-response\n- No previous attempts to lengthen the dosing interval\n- Three consecutive faecal calprotectin (FC) results in the target range (i.e. <250 μg/g for CD patients; <150 μg/g for UC patients) in the previous 6 months or confirmed endoscopic remission within 2 months before study entry (i.e. simple endoscopic score for Crohn’s disease (SES-CD) <3 points; ulcerative colitis endoscopic index of severity (UCEIS) ≤1 point or Mayo endoscopic subscore ≤1 point)\n- Absence of symptoms associated with active IBD (judged by the local IBD-team)\n- Written informed consent granted"}

Exclusion criteria

• {"criterion_text":"- Perianal fistula\n- Presence of ileostomy or ileoanal pouch (as FC cut-off is not validated for small bowel faeces)\n- Any inflammatory comorbidity, such as rheumatoid arthritis\n- Current treatment with corticosteroids (prednisone or budesonide)\n- Current pregnancy"}

Primary endpoints

• {"endpoint_text":"- The cumulative incidence of out-of-range FC results at 48 weeks follow-up","definition_or_measurement_approach":"Cumulative incidence of faecal calprotectin (FC) results that are out-of-range measured at 48 weeks follow-up"}

Secondary endpoints

• {"endpoint_text":"- time to get out-of-range FC results, defined as the time from study baseline until the first out-of-range FC result","definition_or_measurement_approach":"Defined as the time from study baseline until the first out-of-range FC result (time-to-event)"}
• {"endpoint_text":"- cumulative incidence of anti-TNF-associated respiratory infections and dermatological adverse effects (skin infections, new-onset or worsening of psoriasis, eczema, erythema nodosum, pyoderma gangrenosum, seborrheic dermatitis and other skin, hair or nail abnormalities) at 48 weeks follow-up","definition_or_measurement_approach":"Cumulative incidence of specified anti-TNF-associated infections and dermatological adverse effects measured at 48 weeks follow-up"}
• {"endpoint_text":"- evolution of FC and anti-TNF trough levels in the first 16 weeks after reverting to previous dosing interval","definition_or_measurement_approach":"Serial measurement of FC and anti-TNF trough levels over the first 16 weeks after reverting to the previous dosing interval"}
• {"endpoint_text":"- proportion of patients developing loss-of-response in the first 16 weeks after reverting to the previous dosing interval","definition_or_measurement_approach":"Proportion (percentage) of patients who develop loss-of-response within 16 weeks after reverting to the previous dosing interval"}
• {"endpoint_text":"- identification of predictors of successful de-escalation","definition_or_measurement_approach":"Analysis to identify clinical or laboratory predictors associated with successful de-escalation (predictor identification/association analyses)"}

Belgium

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

20-09-2024

Processing Time Days

7

Number Of Sites

3

Number Of Participants

40

Spain

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

23-09-2024

Processing Time Days

10

Number Of Sites

1

Number Of Participants

8

Netherlands

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

6

Number Of Sites

4

Number Of Participants

100

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands