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Completed

NCT Number: NCT03182166

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

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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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Amiens-Picardie, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. correlation between concentration of golimumab and clinical response according to treatment

    Time frame: From baseline to 8 weeks

    Concentration of golimumab is measured by Enzyme Linked ImmunoSorbent Assay (ELISA).

    Clinical response is measured by the Mayo score.

Secondary outcomes

  1. Number of patient with antibodies to golimumab

    Time frame: day 1

    Concentration of antibodies to golimumab is measured by Enzyme Linked ImmunoSorbent Assay( ELISA)

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

    Time frame: From baseline to 8 weeks

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

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

    Time frame: up to 8 weeks

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: GOLILOR

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2017
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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