Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET
Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 4
Details
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives