Optimization of Golimumab Treatment in Ulcerative Colitis

September 11, 2018 updated by: Hospital de Manises
This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Joaquín Hinojosa del Val

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria.

Exclusion Criteria:

  • Patients with Crohn's disease or colitis pending classification
  • Patients with ileoanal pouch
  • Patients with perianal fistulas related to the disease
  • Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet.
  • Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections.
  • Patients with moderate or severe heart failure (NYHA grade III / IV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Week 6 Responders
In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.
Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg
Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels.
Experimental: Week 6 Non Responders
In patients without clinical response at week 6, golimumab treatment will be optimized.
Drug: Golimumab treatment optimization.
Golimumab dosing will be optimized in patients without clinical response at week 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between serum Golimumab levels and clinical response.
Time Frame: Week 6.
Serum Golimumab levels will be measured and clinical activity evaluation will be assessed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin.
Week 6.
Correlation between anti-Golimumab antibody levels and clinical response.
Time Frame: Week 6.
Anti-golimumab antibody levels will be measure and clinical activity evaluation will be performed according to the partial Mayo score and biochemical parameters such as C-reactive protein and calprotectin.
Week 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment optimization outcome.
Time Frame: Week 14
Analyze the percentage of non-responder patients or patients with partial response at week 6 who achieve response/remission at week 14 after treatment optimization.
Week 14
Correlation between mucosal healing and serum Golimumab levels.
Time Frame: Week 54
An endoscopy will be performed at the end of the treatment and serum Golimumab levels will be measured.
Week 54
Identification of cut-off values of serum golimumab concentration
Time Frame: Week 6
Identify useful cut-off values of serum golimumab concentration for use in ulcerative colitis practice.
Week 6
Correlation between mucosal healing and anti-Golimumab antibody levels.
Time Frame: Week 54
An endoscopy will be performed at the end of the treatment and anti-Golimumab antibody levels will be measured.
Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Manises

Collaborators

Merck Sharp & Dohme LLC
Hospital Arnau de Vilanova
Hospital Universitario La Fe
Hospital Provincial de Castellon
Hospital Universitario Doctor Peset
General University Hospital of Valencia
Hospital General Universitario de Alicante
Hospital Clínico Universitario de Valencia
Hospital de Sagunto

Investigators

  • Principal Investigator: Joaquín Hinojosa del Val, MD, Hospital de Manises

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHV-GOL-2018-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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