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

NCT03182166 | Completed Phase 2

• 2 other identifiers: 16081622016-004245-85
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 5

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.

Conditions

Ulcerative Colitis

Keywords

golimumab; clinical response; mayo score; rectosigmoidoscopy; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• correlation between concentration of golimumab and clinical response according to treatment

  Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA). Clinical response is measured by the Mayo score.

  From baseline to 8 weeks

Secondary Outcomes (3)

• Number of patient with antibodies to golimumab

  day 1

• correlation between concentration of antibodies to golimumab and clinical response according to treatment

  From baseline to 8 weeks

• Number of patients with Infectious diseases or Neuropathies or Injection site pain or fever

  up to 8 weeks

Study Arms (1)

Patients treated with golimumab

EXPERIMENTAL

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.

Drug: Golimumab (Optimization); Diagnostic Test: Rectosigmoidoscopy; Biological: Blood samples

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.

Patients treated with golimumab

Rectosigmoidoscopy DIAGNOSTIC_TEST

Rectosigmoidoscopy will be realized for calculated Mayo score

Patients treated with golimumab

Blood samples BIOLOGICAL

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

Patients treated with golimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

CHU Amiens-Picardie

Amiens, France

Location

CHU Lyon Sud

Lyon, France

Location

CHU Montpellier - St Eloi

Montpellier, France

Location

CHU Nice

Nice, France

Location

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xavier ROBLIN, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 9, 2017
• Study Start: November 21, 2017
• Primary Completion: June 25, 2021
• Study Completion: December 15, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)