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

NCT02425865 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-05-31

No results posted yet for this study

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

Interventions

DRUG

GOLIMUMAB

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

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • Laurent Peyrin Biroulet, MD,PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • Lucine Vuitton, MD, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • Edouard Louis, MD, PhD · Centre Hospitalier Universitaire de Liege

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-10-31
Completion
2023-01-31

Countries

  • Belgium
  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425865 on ClinicalTrials.gov