Clinical Trial 51034

Tulsa, OK 74137


Summary:

Phase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease



Criteria:

Patients must have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months duration

Prior or current medication for Crohn’s disease must include at least 1 of the following: 

a. Current treatment with oral corticosteroids (Prednisone or including budesonide and beclomethasone dipropionate) and/or immunomodulators (AZA, 6-MP, MTX)

OR

b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral corticosteroids (including budesonide and beclomethasone dipropionate) or immunomodulators (AZA, 6-MP, MTX)

OR

c. History of corticosteroid dependence (ie, an inability to successfully taper corticosteroids without a return of the symptoms of Crohn’s disease)

OR

d. Has previously demonstrated lack of initial response (ie, primary nonresponders), responded initially but then lost response with continued therapy (ie, secondary nonresponders), or were intolerant to 1 or more biologic agents at a dose that is, at minimum, a locally approved dose for the treatment of Crohn's disease (ie, infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents)


Qualified Participants May Receive:

All study related procedures (EKG/Labs/colonoscopy/Physical exam)  and medication at no cost/no insurance. 

Board Certified phyiscian visits 

 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.