Comparison of azathioprine to methotrexate in combination therapy with adalimumab in Crohn’s Disease: an open-label randomized controlled trial

Conditions

Crohn’s Disease

Brief summary

Endoscopic response defined as a decrease of at least 50% of the SES-CD at week W26 as compared to baseline

Detailed description

Clinical response at each visit, Clinical remission at each visit, Corticosteroid-free clinical remission at W12, W26, W52, W78 and W104, Necessity of adalimumab optimization during follow-up, AZA, MTX and adalimumab withdrawal during follow-up, Trough serum levels and antibodies to adalimumab at W12-W26, W52, W78 and W104, Change in IBD-Q and change in IBD-Disability index between W0 and W12, W26, W52, W78 and W104, Change in C-reactive protein (CRP) level between W0, W12, W26, W52, W78 and W104, Change in Calprotectin level between W0, W12, W26, W52, W78 and W104, Endoscopic remission (SES-CD< 3) and ulcer free endoscopy at W26, Deep remission at W26, CD-related hospitalization during follow-up, CD-related surgery during follow-up, Occurrence of adverse events

Related papers

No related papers found yet.

Interventions

DRUGMETOJECT 25 mg/0

DRUG5 ml

DRUGsolution injectable en seringue préremplie

DRUGHumira 20 mg solution for injection in pre-filled syringe

DRUGIMUREL 25 mg

DRUGcomprimé pelliculé

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Endoscopic response defined as a decrease of at least 50% of the SES-CD at week W26 as compared to baseline	—

Secondary

Measure	Time frame
Clinical response at each visit, Clinical remission at each visit, Corticosteroid-free clinical remission at W12, W26, W52, W78 and W104, Necessity of adalimumab optimization during follow-up, AZA, MTX and adalimumab withdrawal during follow-up, Trough serum levels and antibodies to adalimumab at W12-W26, W52, W78 and W104, Change in IBD-Q and change in IBD-Disability index between W0 and W12, W26, W52, W78 and W104, Change in C-reactive protein (CRP) level between W0, W12, W26, W52, W78 and W104, Change in Calprotectin level between W0, W12, W26, W52, W78 and W104, Endoscopic remission (SES-CD< 3) and ulcer free endoscopy at W26, Deep remission at W26, CD-related hospitalization during follow-up, CD-related surgery during follow-up, Occurrence of adverse events	—

Measure

Time frame

Clinical response at each visit, Clinical remission at each visit, Corticosteroid-free clinical remission at W12, W26, W52, W78 and W104, Necessity of adalimumab optimization during follow-up, AZA, MTX and adalimumab withdrawal during follow-up, Trough serum levels and antibodies to adalimumab at W12-W26, W52, W78 and W104, Change in IBD-Q and change in IBD-Disability index between W0 and W12, W26, W52, W78 and W104, Change in C-reactive protein (CRP) level between W0, W12, W26, W52, W78 and W104, Change in Calprotectin level between W0, W12, W26, W52, W78 and W104, Endoscopic remission (SES-CD< 3) and ulcer free endoscopy at W26, Deep remission at W26, CD-related hospitalization during follow-up, CD-related surgery during follow-up, Occurrence of adverse events

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Countries

France

Outcome results

None listed