A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

Janssen-Cilag International N.V.0 sites40 target enrollmentOctober 26, 2016

Overview

No summary available.

Registry

who.int

Start Date

October 26, 2016

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Be a pediatric subject 2 to \<18 years old in the US, 6 to \<18 years old elsewhere, of either gender.
•2\. Have CD or fistulizing CD of at least 3 months duration, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.
•3\. Must have moderately to severely active CD
•4\. Prior or current medication for CD must include at least 1 of the following:
•a. Current treatment with at least 1 of the following therapies: oral corticosteroids, the
•immunomodulators AZA, 6\-MP, or MTX, or currently have or have had a history of corticosteroid dependency
•b. Have a history of failure to respond to, or tolerate, at least 1 of the following therapies:
•oral or IV corticosteroids, the immunomodulators AZA, 6\-MP, or MTX.
•c. Have required more than 3 courses of oral or IV corticosteroids in the past year.
•5\. Must meet the following requirements for current concomitant medications for CD criteria:

•Disease Characteristics
•1\. Has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the PCDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
•2\. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses
•are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra\-abdominal abscesses, provided that there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified.
•3\. Has had any kind of bowel resection within 6 months or any other intra\-abdominal surgery within 3 months prior to baseline.
•4\. Has a draining (ie, functioning) stoma or ostomy.
•Concomitant or Previous Medical Therapies Received
•5\. Has received any of the following prescribed medications or therapies within the specified
•a. IV corticosteroids \<3 weeks prior to baseline.
•b. Natalizumab within 12 months of baseline.