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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2021-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Golimumab (Optimization)

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Rectosigmoidoscopy will be realized for calculated Mayo score

Blood samples

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type DRUG

Rectosigmoidoscopy

Rectosigmoidoscopy will be realized for calculated Mayo score

Intervention Type DIAGNOSTIC_TEST

Blood samples

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No