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Protocol GA29144
Title PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERLY ACTIVE CROHNíS DISEASE
Phase III
Area GI
Indication

Moderate to Severe Crohn's Disease

Treatment

 ETROLIZUMAB vs placebo

Requirement

CS Therapy
Refractory
:
Has signs/symptoms of persistently active disease despite a history of at
least one 4-week induction regimen including a dose equivalent to
≥ 30 mg/day prednisone for 2 weeks if oral or 1 week if IV
Intolerance to CS therapy:
History including but not limited to Cushing’s syndrome,
osteopenia/osteoporosis, hyperglycemia, insomnia, and infection
IS Therapy
Refractory
:
Has signs/symptoms of persistently active disease despite a history of at
least one 12-week regimen of oral AZA (≥ 1.5 mg/kg) or 6-MP
(≥ 0.75 mg/kg) or MTX (≥ 15 mg/week)
Intolerance to 6-MP, AZA, or MTX:
History of intolerance to ≥ 1 of the above (including but not limited to
infection, nausea/vomiting, abdominal pain, pancreatitis, liver function test
abnormalities, lymphopenia, and thiopurine methyltransferase genetic
polymorphism)
Anti-TNF Therapy:
Inadequate primary non-response:
Did not respond (as evidenced by persistent signs/symptoms related to CD
after receiving ≥ 2 induction doses of either infliximab [≥ 5 mg/kg] or
adalimumab [160 mg/80 mg or 80 mg/40 mg] or certolizumab pegol
[≥ 400 mg])
Inadequate secondary non-response:
Initially responded to induction therapy with infliximab (≥ 5 mg/kg) or
adalimumab (≥ 40 mg) or certolizumab pegol (≥ 400 mg) but experienced
signs/symptoms related to recurrence of CD during maintenance
Intolerance:
Experienced a significant injection-site reaction, congestive heart failure,
infection, or other condition that precluded continuing use of anti-TNF
therapy at any time

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