NL-OMON38117
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- Janssen-Cilag
- Enrollment
- 32
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Each potential subject must satisfy all of the following criteria to be enrolled in the study. Each
- •subject must:
- •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 (ie, primary nonresponders);
- •b. Responded initially but then lost response with continued therapy (ie, secondary
- •nonresponders);
- •c. Were intolerant to the medication.;5\. Adhere to the following requirements for concomitant medication for the treatment of
Exclusion Criteria
- •Any potential subject who meets any of the following criteria will be excluded from participating
- •in the study. The subject will be excluded if he or she:
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Chronic Migraine - the REGAIN Studychronic migraineheadache10019231NL-OMON46093Eli Lilly54
Completed
Phase 3
A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dacetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trialAcute Coronary syndromearterial disease10028593NL-OMON55786DalCor Pharma UK Ltd276
Completed
Phase 3
A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral SclerosisNL-OMON48938Orphazyme A/S19
Completed
Phase 3
A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot UlcerNL-OMON43839Innocoll Pharmaceuticals Ltd.8
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled Trial Investigating The Effect Of Ticagrelor On Saphenous Vein Graft Patency In Patients Undergoing Coronary Artery Bypass Grafting Surgery.bypass surgeryCoronary artery bypass grafting10011082NL-OMON50593Sint Antonius Ziekenhuis499