A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1

Janssen-Cilag International N.V.0 sites675 target enrollmentAugust 10, 2011

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Janssen-Cilag International N.V.
Enrollment: 675
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 10, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International N.V.

Eligibility Criteria

Inclusion Criteria

•1\. Be a man or woman \= 18 years of age.
•2\. Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.
•3\. Have active Crohn’s disease, defined as a baseline CDAI score of \= 220 and \= 450\.
•4\. Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn’s disease and
•a. Did not respond initially;
•b. Responded initially but then lost response with continued therapy;
•c. Were intolerant to the medication.
•5\. Adhere to the following requirements for concomitant medication for the treatment of Crohn’s disease. The following medications are permitted provided doses meeting the requirements below are stable for or have been discontinued at least 3 weeks prior to baseline (Week 0\), unless otherwise specified.
•a. Oral 5\-ASA compounds.
•b. Oral corticosteroids at a prednisone\-equivalent dose of \= 40 mg/day or \= 9 mg/day of budesonide.

Exclusion Criteria

•1\. Has complications of Crohn’s disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI 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 stoma or ostomy.
•5\. Has received any of the prescribed medications or therapies within the specified period (mentioned in the protocol).
•6\. Have a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
•7\. Has previously received a biologic agent targeting IL\-12 or IL\-23, including but not limited to ustekinumab (CNTO 1275\) or briakinumab (ABT\-874\).
•8\. Has received a Bacille Calmette\-Guérin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks of baseline.
•9\. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.
•10\. Has current signs or symptoms of infection. Established nonserious infections need not be considered exclusionary at the discretion of the investigator.