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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Study ID
NCT03182166
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golimumab (Optimization) — DRUG
    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.
  • Rectosigmoidoscopy — DIAGNOSTIC_TEST
    Rectosigmoidoscopy will be realized for calculated Mayo score
  • Blood samples — BIOLOGICAL
    Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood

Study Details

It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.

Key Dates

Start date
Nov 21, 2017
Status verified
Feb 2022
Primary completion
Jun 25, 2021
Completion
Dec 15, 2021

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients treated with golimumab
    The optimization procedure is: * For patients treated at 50 mg of golimumab every 4 weeks (less than 80 kg) will have an increase dose of golimumab: 100 mg every 4 weeks for 8 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies. * For patients treated at 100 mg of golimumab every four weeks (more than 80 kg) will have an increase dose of golimumab: treated at 100 mg every 2 weeks for 4 weeks. They will have rectosigmoidoscopy for measured mayo score and blood samples for measured the concentration of golimumab antibodies.

Primary Outcome Measure

correlation between concentration of golimumab and clinical response according to treatment [ Time Frame: From baseline to 8 weeks ]

Related Studies