Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

November 21, 2017

Primary Completion Date

June 25, 2021

Study Completion Date

December 15, 2021

Conditions
Ulcerative Colitis
Interventions
DRUG

Golimumab (Optimization)

"Increase dose of golimumab.~* For patients treated at 50 mg will be performed, dose will be intensified at 100 mg every four weeks.~* For patients treated at 100 mg will be performed, dose will be intensified at 100 mg every two weeks while four weeks."

DIAGNOSTIC_TEST

Rectosigmoidoscopy

Rectosigmoidoscopy will be realized for calculated Mayo score

BIOLOGICAL

Blood samples

Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood

Trial Locations (5)

42055

Chu Saint Etienne, Saint-Etienne

Unknown

CHU Amiens-Picardie, Amiens

CHU Lyon Sud, Lyon

CHU Montpellier - St Eloi, Montpellier

CHU Nice, Nice

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER

NCT03182166 - Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization | Biotech Hunter | Biotech Hunter