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

NCT02425865 | Completed Phase 4

• 1 other identifier: GETAID 2015-05
• Study Type: interventional
• Target: 202
• Locations: 2 countries
• Sites: 23

Brief 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. 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)

Conditions

ULCERATIVE COLITIS

Keywords

UC, IBD

Outcome Measures

Primary Outcomes (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

  Week 54

Secondary Outcomes (15)

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

  Week 108

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

  Week 54

• Clinical remission at week 54

  week 54

• Clinical remission at week 108

  week 108

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

  week 108

Study Arms (1)

open-label, uncontrolled trial

OTHER

All patients will receive Standard regimen with golimumab 50 mg Q4W, or 100 mg Q4W if \> 80 kg

Drug: GOLIMUMAB

Interventions

GOLIMUMAB DRUG

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

open-label, uncontrolled trial

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead

Study Sites (23)

CHU LIEGE - Sart Tilman

Liège, 4000, Belgium

Location

CHU Dinant Godinne UCL Namur

Namur, Belgium

Location

CHU Amiens

Amiens, 80054, France

Location

Chu Besancon

Besançon, France

Location

Caen Unversity Hospital

Caen, 14033, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

APHP- Hopital BEAUJON

Clichy, 92110, France

Location

CHU de Colmar- Hopital Trousseau Medecine A

Colmar, 68024, France

Location

CHRU Lille

Lille, France

Location

CHU de Montpellier- Hopital saint Eloi

Montpellier, 34295, France

Location

CHU NANTES - Hôpital Hôtel Dieu

Nantes, 44093, France

Location

CHU de NICE- Hopital Archet 2

Nice, 06200, France

Location

CHU de Nimes- Hopital Carémeau

Nîmes, 30029, France

Location

APHP- Hopital BICHAT

Paris, 75018, France

Location

CHU Bordeaux- Hopital Haut Levèque

Pessac, 33600, France

Location

CHU LYON- Hopital Lyon Sud

Pierre-Bénite, 69495, France

Location

Chu Reims

Reims, France

Location

CHU RENNES - Hopital Pontchaillou

Rennes, France

Location

CHU de Saint Etienne- Hopital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Chu Strasbourg

Strasbourg, 67091, France

Location

CHU de TOULOUSE

Toulouse, 31403, France

Location

CHU de Tours - Hopital Trousseau

Tours, 37044, France

Location

CHU NANCY - Hopital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab

Condition Hierarchy (Ancestors)

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

Study Officials

• 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 Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 24, 2015
• Study Start: December 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

FR (21); BE (2)