NCT06180382View on ClinicalTrials.gov

Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.

PHASE4RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2027

Conditions
Crohn's Disease
Interventions
DRUG

Adalimumab

Administration of adalimumab with optimisation either 80 mg every 14 days by subcutaneous injection, or the same dose of 40 mg every 7 days.

DRUG

Vedolizumab

Strategy B: administration of vedolizumab 300mg by infusion at baseline, 14 days, 42 days and 60 days, followed by a dose of 108mg every fortnight by subcutaneous injection.

Trial Locations (12)

13000

RECRUITING

APHM, Marseille

33604

RECRUITING

CHU Bordeaux, Pessac

34295

RECRUITING

CHU Montpellier, Montpellier

35033

RECRUITING

CHU Rennes, Rennes

42055

RECRUITING

CHU de Saint-Etienne, Saint-Etienne

59037

RECRUITING

CHRU Lille, Lille

69230

RECRUITING

Ch Lyon Sud, Pierre-Bénite

75004

RECRUITING

Assistance Publique - Hôpitaux de Paris, Paris

80000

RECRUITING

CHU Amiens, Amiens

87000

RECRUITING

Chu Limoges, Limoges

94270

RECRUITING

APHP - Hôpital Bicêtre, Le Kremlin-Bicêtre

06202

RECRUITING

Hôpital de l'Archet II, Nice

All Listed Sponsors
collaborator

Takeda France

INDUSTRY

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER

NCT06180382 - Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration. | Biotech Hunter | Biotech Hunter