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

Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study ID
NCT02425865
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GOLIMUMAB — DRUG
    Increase/ or Decrease/ Interruption Dose of Golimumab depending on Continuous Clinical Response or Relapse

Study Details

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)

Key Dates

Start date
Dec 31, 2016
Status verified
May 2023
Primary completion
Oct 31, 2021
Completion
Jan 31, 2023

Study Design

Enrollment
202 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: open-label, uncontrolled trial
    All patients will receive Standard regimen with golimumab 50 mg Q4W, or 100 mg Q4W if \> 80 kg

Primary Outcome Measure

Continuous Clinical Response and Endoscopic Remission [ Time Frame: Week 54 ]

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