FREE-study; De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring

Conditions

Crohn's disease Ulcerative colitis

Brief summary

The cumulative incidence of out-of-range FC results at 48 weeks follow-up

Detailed description

time to get out-of-range FC results, defined as the time from study baseline until the first out-of-range FC result, 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, evolution of FC and anti-TNF trough levels in the first 16 weeks after reverting to previous dosing interval, proportion of patients developing loss-of-response in the first 16 weeks after reverting to the previous dosing interval, identification of predictors of successful de-escalation

Related papers

No related papers found yet.

Interventions

DRUGADALIMUMAB

DRUGINFLIXIMAB

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The cumulative incidence of out-of-range FC results at 48 weeks follow-up	—

Secondary

Measure	Time frame
time to get out-of-range FC results, defined as the time from study baseline until the first out-of-range FC result, 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, evolution of FC and anti-TNF trough levels in the first 16 weeks after reverting to previous dosing interval, proportion of patients developing loss-of-response in the first 16 weeks after reverting to the previous dosing interval, identification of predictors of successful de-escalation	—

Measure

Time frame

time to get out-of-range FC results, defined as the time from study baseline until the first out-of-range FC result, 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, evolution of FC and anti-TNF trough levels in the first 16 weeks after reverting to previous dosing interval, proportion of patients developing loss-of-response in the first 16 weeks after reverting to the previous dosing interval, identification of predictors of successful de-escalation

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Countries

Belgium, Netherlands, Spain

Outcome results

None listed