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C0743T26/ CERTFI
Title: A phase IIb, multicenter,
randomized, double-blind, placebo-controlled, parallel-group
study to evaluate the efficacy and safety of Ustekinumab
therapy in subjects with moderately to severely active
Crohn’s Disease previously treated with TNF antagonist
therapy
Diagnosis: Crohn’s Disease
Primary Objective: to evaluate
the safety and efficacy of Ustekinumab (infused study
medication) with results of a response in 4 weeks and
remission to subjects who respond to Ustekinumab
Eligibility: In order to
participate in the study the subject must meet all of the
requirements listed:
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Males and females over the age of 18
years.
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Diagnosed with Crohn’s Disease or
fistulizing Crohn’s disease of at least 3 months duration,
with colitis, ileitis, or ileocolitis, confirmed by
radiography and/or Endoscopy
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Have received Remicade therapy at a
dose approved for the treatment of Crohn’s disease and had
one of the following outcomes:
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Did not respond initially
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Responded initially but then lost
response with continued therapy
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Were intolerant to the medication
Treatment: Participants must sign a
consent form and will be randomized to 1 of 4 treatment
arms.
*Participants are asked to keep a diary for 8 weeks and
dependent upon response to the dose, the subject may be
randomized at week 6 for a maintenance dose or placebo.
If interested, please
contact Jennifer Hudgins
410-494-1846 x134 or
jhudgins@gastro-doc.com
Or fill out the
Application to Participate
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