Clinical trial NCT03182166: Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
Official title: Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: golimumab
clinical response
mayo score
rectosigmoidoscopy
ulcerative colitis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-06-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Affiliate or beneficiary of social security
* Age\>18 years
* Pregnant women or man
* Presenting primary response under golimumab induction and in loss of response during maintenance therapy
* Patient with an ulcerative colitis
* Treated with golimumab
* Signature of consent

Exclusion Criteria:

* Trying to become pregnant
* Mental or emotional disorders
* Patients with crohn's disease or indeterminate colitis
* cancer(\<5)
* Patients not in agreement with this study protocol
* Patients with crohn's disease or indeterminate colitis
* Patients non primary responder to golimumab

Primary outcomes:
measure: correlation between concentration of golimumab and clinical response according to treatment
timeFrame: From baseline to 8 weeks
Secondary outcomes:
measure: Number of patient with antibodies to golimumab
timeFrame: day 1
measure: correlation between concentration of antibodies to golimumab and clinical response according to treatment
timeFrame: From baseline to 8 weeks
measure: Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Lyon
country: France
facility: CHU Lyon Sud
city: Montpellier
country: France
facility: CHU Montpellier - St Eloi
city: Nice
country: France
facility: CHU Nice
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Xavier ROBLIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: