Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET (In-TARGET)

May 30, 2023 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET

PHASE: IV

TYPE OF STUDY: With direct benefit

DESCRIPTIVE: multicenter, open-label, uncontrolled trial

INCLUSION CRITERIA: Adults with moderate to severe ulcerative colitis who failed corticosteroids and immunosupressive therapy, or are intolerant to immunosuppressors. All included patients will be naïve to anti-TNF therapy. Active disease at golimumab treatment initiation defined as a MAYO score ≥6 and with an endoscopic sub score ≥2.

OBJECTIVE: To determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54.

STUDY DESIGN:

Induction Phase :

Week 0: golimumab 200mg- Week 2: golimumab 100 mg- Week 6: golimumab 50 mg

Maintenance Phase I : Week 10-Week 54 Week 10-Week 54 • Patients with primary clinical response*: Standard regimen with golimumab 50 mg Q4W (or 100 mg Q4W if > 80 kg)

  • Patients without primary clinical response at week 10 or with flare between week 10-week 54*: Optimization to 100 mg Q4W (or combination therapy with azathioprine if > 80 kg or switch from azathioprine to methotrexate if already on azathioprine at golimumab initiation or patient with known intolerance to thiopurines)

  • Early escape at Week 18: Primary non-responders who are still not responding at week 18 to dose optimization at Weeks 10 and 14 will be considered treatment failures and will be followed up (call or visit) at week 54 for safety.

    • Clinical response is defined as a decrease from baseline in the Mayo score ≥30% and ≥3 points, accompanied by either a rectal bleeding sub score of 0 or 1 or a decrease from baseline in the rectal bleeding sub score ≥1

Intermittent Phase II : Week 54-Week 108

• Patients with CCR and MH at week 54 and on golimumab 50 mg every 4 weeks: Stop golimumab and continuation of thiopurines or methotrexate if on combination therapy

• Patients with CCR and MH at week 54 and on golimumab 100 mg every 4 weeks: De-escalation to 50 mg every 4 weeks and continuation of thiopurines or methotrexate if on combination therapy

• Restart/Escalate golimumab on flare (defined in section 4 of the protocol) to the phase I dose; 50 mg q4wk or 100mg q4wk (similar to the phase I regimen)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

NUMBER OF PATIENTS: 200 patients

INCLUSION PERIOD: 33 months

STUDY DURATION: 57 months

MAIN EVALUATION Primary endpoints

• Week 10-54: proportion of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54

Data base lock, data analysis and display (publication) will happen when all included subjects have completed the 108-week visit.

SECONDARY EVALUATION

For all included patients:

  • Phase II (week 54-108): proportion of patients in CCR with MH (endoscopic Mayo score of 0 or 1) at week 108, after discontinuation or dose de-escalation (from 100 to 50 mg) of golimumab treatment at year 1 in the subgroup of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54
  • Factors associated with treatment success (see primary endpoint)
  • Efficacy of dose optimization in patients who loose response between week 10 and 54
  • Clinical remission at week 54 • Clinical remission at week 108 • Partial MAYO score at week 54 and 108 • PRO2 (Partial Mayo minus PGA) at week 54 and 108 • CCR between study inclusion and week 54 and 108 • Steroid-free clinical remission at week 54 and 108 • MH (endoscopic score MAYO 0-1) at week 54 and 108 • Changes in faecal calprotectin levels from baseline to week 54 and 108 • Colectomy between W0 and W54 and 108
  • UC-related hospitalizations throughout the trial • Histological remission9 at W54 and 108
  • PRO: Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS)
  • PK data (golimumab trough levels and antibodies against golimumab)
  • Proportion of late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase

For the subgroup of patients who are primary non-responders to golimumab at week 10, we will assess the efficacy of treatment optimization, including the percentage of patients achieving continuous clinical response and endoscopic remission at one year.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Belgium
      • Liege, Belgium, 4000
        • CHU Liège - Sart Tilman
      • NAmur, Belgium
        • CHU Dinant Godinne UCL Namur
  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Besançon, France
        • CHU Besançon
      • Caen, France, 14033
        • Caen Unversity Hospital
      • Clermont-Ferrand, France, 63003
        • Chu Clermont Ferrand
      • Clichy, France, 92110
        • APHP- Hopital Beaujon
      • Colmar, France, 68024
        • CHU de Colmar- Hopital Trousseau Medecine A
      • Lille, France
        • CHRU Lille
      • Montpellier, France, 34295
        • CHU de Montpellier- Hôpital Saint Eloi
      • Nantes, France, 44093
        • CHU NANTES - Hôpital Hôtel Dieu
      • Nice, France, 06200
        • CHU de NICE- Hopital Archet 2
      • Nîmes, France, 30029
        • CHU de Nimes- Hopital Carémeau
      • Paris, France, 75018
        • APHP- Hôpital Bichat
      • Pessac, France, 33600
        • CHU Bordeaux- Hopital Haut Levèque
      • Pierre-Bénite, France, 69495
        • CHU LYON- Hopital Lyon Sud
      • Reims, France
        • CHU Reims
      • Rennes, France
        • CHU Rennes - Hopital Pontchaillou
      • Saint-Priest-en-Jarez, France, 42270
        • CHU de Saint Etienne- Hopital Nord
      • Strasbourg, France, 67091
        • CHU Strasbourg
      • Toulouse, France, 31403
        • CHU de Toulouse
      • Tours, France, 37044
        • CHU de Tours - Hopital Trousseau
      • Vandoeuvre Les Nancy, France, 54500
        • CHU Nancy - Hôpital Brabois

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA

  • Age sup 18 years and inf 75 years
  • Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and or proctitis are allowed).
  • Adults with moderately-to-severely active UC who had an inadequate response to or failed to tolerate steroids AND thiopurines (azathioprine or 6-mercaptopurine) or adults with moderately-to-severely active UC who had no response to an adequate steroid course and starting golimumab.
  • Active disease at golimumab treatment initiation defined as a partial MAYO score sup/equal 6 with an endoscopic sub score sup/equal 2.
  • Patients concurrently treated with oral corticosteroids will receive a stable dose (prednisone 20 ≤mg/day for at least 2 weeks) before baseline.
  • Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication. If the patient is not on oral 5-ASA during the screening period, he/she should start mesalamine at 2g per day or asacol at 1.6 g per day, in the absence of contra-indication.
  • Patients are allowed stable dose of thiopurines (azathioprine or 6-mercaptopurine stable dose for at least 4 weeks).
  • Naïve to anti-TNF therapy, and other biologics, including anti-integrin antibodies and for all biologics known to be effective for UC (approved or investigational).
  • Naïve to JAK inhibitors (approved or investigational)
  • A contraceptive method during the whole study for childbearing potential female patients.

EXCLUSION CRITERIA

  • Age under 18 and over 75.
  • People unable to give their consent (because of their physical or mental state).
  • Absence of written consent.
  • Pregnancy or breastfeeding.
  • Patients with severe acute colitis or patients at imminent risk for colectomy.
  • History of colectomy.
  • History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
  • Screening stool study positive for enteric pathogens or Clostridium difficile toxin.
  • Oral corticosteroids at a dose > 20 mg prednisone or its equivalent per day.
  • Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics, including anti-integrin antibodies (approved or investigational), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first study agent injection.

  • Contraindication to anti-TNF therapy according to drug labelling:

    • Active infection.
    • Non-treated latent tuberculosis.
    • Heart failure (NYHA: Grade III and IV).
    • Malignancy during the previous 5 years.
    • Demyelinating neurological disease.
    • Should be vaccinated with attenuated live vaccines

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: open-label, uncontrolled trial
All patients will receive Standard regimen with golimumab 50 mg Q4W, or 100 mg Q4W if > 80 kg
Drug: GOLIMUMAB
Increase/ or Decrease/ Interruption Dose of Golimumab depending on Continuous Clinical Response or Relapse

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continuous Clinical Response and Endoscopic Remission
Time Frame: Week 54
proportion of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54
Week 54

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continuous Clinical Response and Endoscopic Remission after discontinuation or de- escalation of golimumab
Time Frame: Week 108
proportion of patients maintaining continuous clinical response and endoscopic remission at week 108, after discontinuation or de-escalation of golimumab treatment at year 1 in the subgroup of patients in continuous clinical response (CCR) and with mucosal healing (endoscopic Mayo score of 0 or 1) at week 54
Week 108
Efficacy of dose optimization in patients who loose response between week 10 and 54
Time Frame: Week 54
proportion of patients maintaining continuous clinical response after dose optimization in patients who loose response between week 10 and 54
Week 54
Clinical remission at week 54
Time Frame: week 54
proportion of patient with clinical remission (partial Mayo score) at week 54
week 54
Clinical remission at week 108
Time Frame: week 108
proportion of patient with clinical remission (partial mayo score) at week 108
week 108
PRO2 (Partial Mayo minus PGA) at week 54 and 108
Time Frame: week 108
Evolution of PRO2 (Partial Mayo minus PGA) at week 54 and 108 according the clinical and endoscopic remission
week 108
CCR between study inclusion and week 54 and 108
Time Frame: week 108
proportion of patient with CCR at week 54 and 108
week 108
Steroid-free clinical remission at week 54 and 108
Time Frame: week 108
proportion of patient with steroid-free clinical remission at week 54 and 108
week 108
MH (endoscopic score MAYO 0-1) at week 54 and 108
Time Frame: week 108
proportion of patient with MH (endoscopic score MAYO 0-1) at week 54 and 108
week 108
Changes in faecal calprotectin levels from baseline at week 54 and 108
Time Frame: week 108
Evolution of faecal calprotectin levels from baseline at week 54 and 108 according the clinical and endoscopic remission
week 108
Colectomy between W0 and W54 and 108
Time Frame: week 108
Proportion of patient with colectomy between W0 and W54 and W108
week 108
UC-related hospitalizations throughout the trial
Time Frame: week 108
Proportion of patient with UC-related hospitalizations throughout the trial
week 108
Histological remission at W54 and 108
Time Frame: week 108
Proportion of patient with histological remission at W54 and W108
week 108
PRO: Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS)
Time Frame: week 108
Evolution of PRO: Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS) according the clinical and endoscopic remission
week 108
PK data (golimumab trough levels and antibodies against golimumab)
Time Frame: week 108
Evolution of PK (golimumab trough levels and antibodies against golimumab) according the clinical and endoscopic remission
week 108
Late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase
Time Frame: week 108
Proportion of late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase
week 108

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent Peyrin Biroulet, MD,PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  • Principal Investigator: Lucine Vuitton, MD, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  • Principal Investigator: Edouard Louis, MD, PhD, Centre Hospitalier Universitaire de Liège

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GETAID 2015-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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