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ULCERATIVE COLITISPhase 4In-TARGETNCT02425865

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

A Phase 4 study testing GOLIMUMAB in people with ULCERATIVE COLITIS, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
ULCERATIVE COLITIS
What is being tested?
GOLIMUMAB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
23 sitesin 2 countries
Study dates
Dec 2016to Jan 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

France21 sites

  • CHU Amiens

    Amiens, 80054

  • Chu Besancon

    Besançon

  • Caen Unversity Hospital

    Caen, 14033

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • APHP- Hopital BEAUJON

    Clichy, 92110

  • CHU de Colmar- Hopital Trousseau Medecine A

    Colmar, 68024

  • CHRU Lille

    Lille

  • CHU de Montpellier- Hopital saint Eloi

    Montpellier, 34295

  • CHU NANTES - Hôpital Hôtel Dieu

    Nantes, 44093

  • CHU de NICE- Hopital Archet 2

    Nice, 06200

  • CHU de Nimes- Hopital Carémeau

    Nîmes, 30029

  • APHP- Hopital BICHAT

    Paris, 75018

  • CHU Bordeaux- Hopital Haut Levèque

    Pessac, 33600

  • CHU LYON- Hopital Lyon Sud

    Pierre-Bénite, 69495

  • Chu Reims

    Reims

  • CHU RENNES - Hopital Pontchaillou

    Rennes

  • CHU de Saint Etienne- Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Chu Strasbourg

    Strasbourg, 67091

  • CHU de TOULOUSE

    Toulouse, 31403

  • CHU de Tours - Hopital Trousseau

    Tours, 37044

  • CHU NANCY - Hopital Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Belgium2 sites

  • CHU LIEGE - Sart Tilman

    Liège, 4000

  • CHU Dinant Godinne UCL Namur

    Namur

Other trials in Belgium

About this study

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

PHASE: IV

TYPE OF STUDY: With direct benefit

Read more

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)
Read the 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.

Being tested
GOLIMUMAB
Keywords
UC, IBD
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GOLIMUMABDrug

    Increase/ or Decrease/ Interruption Dose of Golimumab depending on Continuous Clinical Response or Relapse

Study groups in NCT02425865
Study groupRoleWhat they receive
open-label, uncontrolled trialOtherAll patients will receive Standard regimen with golimumab 50 mg Q4W, or 100 mg Q4W if > 80 kg
Receives: Drug: GOLIMUMAB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous Clinical Response and Endoscopic Remission

    proportion of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54

    Measured: Week 54

Secondary outcomes (15)

  1. Continuous Clinical Response and Endoscopic Remission after discontinuation or de- escalation of golimumab

    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

    Measured: Week 108

  2. Efficacy of dose optimization in patients who loose response between week 10 and 54

    proportion of patients maintaining continuous clinical response after dose optimization in patients who loose response between week 10 and 54

    Measured: Week 54

  3. Clinical remission at week 54

    proportion of patient with clinical remission (partial Mayo score) at week 54

    Measured: week 54

  4. Clinical remission at week 108

    proportion of patient with clinical remission (partial mayo score) at week 108

    Measured: week 108

  5. PRO2 (Partial Mayo minus PGA) at week 54 and 108

    Evolution of PRO2 (Partial Mayo minus PGA) at week 54 and 108 according the clinical and endoscopic remission

    Measured: week 108

  6. CCR between study inclusion and week 54 and 108

    proportion of patient with CCR at week 54 and 108

    Measured: week 108

  7. Steroid-free clinical remission at week 54 and 108

    proportion of patient with steroid-free clinical remission at week 54 and 108

    Measured: week 108

  8. MH (endoscopic score MAYO 0-1) at week 54 and 108

    proportion of patient with MH (endoscopic score MAYO 0-1) at week 54 and 108

    Measured: week 108

  9. Changes in faecal calprotectin levels from baseline at week 54 and 108

    Evolution of faecal calprotectin levels from baseline at week 54 and 108 according the clinical and endoscopic remission

    Measured: week 108

  10. Colectomy between W0 and W54 and 108

    Proportion of patient with colectomy between W0 and W54 and W108

    Measured: week 108

  11. UC-related hospitalizations throughout the trial

    Proportion of patient with UC-related hospitalizations throughout the trial

    Measured: week 108

  12. Histological remission at W54 and 108

    Proportion of patient with histological remission at W54 and W108

    Measured: week 108

  13. PRO: Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS)

    Evolution of PRO: Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS) according the clinical and endoscopic remission

    Measured: week 108

  14. PK data (golimumab trough levels and antibodies against golimumab)

    Evolution of PK (golimumab trough levels and antibodies against golimumab) according the clinical and endoscopic remission

    Measured: week 108

  15. Late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase

    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

    Measured: week 108

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2015 (estimated)
  2. Study startDec 2016
  3. Primary completionOct 2021
  4. Study completionJan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02425865
Sponsor's protocol ID
GETAID 2015-05
Acronym
In-TARGET
Status last verified
May 2023
First submitted
21 Apr 2015
Last updated
31 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing GOLIMUMAB in people with ULCERATIVE COLITIS, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous Clinical Response and Endoscopic Remission (time frame: Week 54). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02425865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

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