A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) | Completed
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Crohn's Disease
  • IBD
  • Colitis
  • Inflammatory Bowel Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).
Research Details
  • This study (CNTO1275CRD3001 or "UNITI-1") examines ustekinumab (an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical except without the ustekinumab antibody) given intravenously (by an IV) in adults with moderately to severely active Crohn's disease who previously did not respond to, lost response to, or could not tolerate TNF-antagonist medications (specifically, infliximab, adalimumab or certolizumab pegol). Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab can provide benefit in Crohn's disease and also assess for any risks or side effects. Both the positive and negative outcomes of IV placebo versus two different doses of IV ustekinumab will be tracked and compared over eight weeks, in approximately 703 patients. Patients enrolling in this study will be assigned to one of the 3 treatment groups by chance (randomly, like rolling dice), and all will receive a single IV administration of study agent at the first study visit (after the screening period), and then will be asked to return for 3 additional visits through Week 8. Patients who complete this study through the Week 8 visit and remain eligible can enter the maintenance study (CNTO1275CRD3003 or "IM-UNITI"), where they will receive additional study agent, including the administration of ustekinumab in patients who receive placebo in this study and have not had improvement in their Crohn's disease. Patients who do not enter the CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after they received study agent when they entered into this study at the Week 0 visit. .All patients will receive a single intravenous (IV) administration of study drug (either placebo or ustekinumab) at the first (week 0) visit when they enter the study.There are 3 treatment groups: Group 1: Placebo; Group 2: ustekinumab 130 mg, Group 3: weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Drug : Group 2 ustekinumab 130 mg, Drug : Group 3: ustekinumab approximately 6 mg/kg, Drug : Group 1: Placebo

Study Arm Groups : 002, 003, 001

Intervention Type
See Interventions above
Primary Outcome Measures
  • Clinical Response; Week 6
Secondary Outcome Measures
  • Clinical remission; Week 8; Clinical improvement/response; Study visits through Week 8
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Age Range
18 Years - N/A
Who Can Participate
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or
  • ileocolitis, confirmed at some time in the past by radiography, histology, or
  • endoscopy
  • - Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index
  • (CDAI) score of >= 220 and <= 450
  • - Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for
  • the treatment of Crohn disease and did not respond initially (ie, primary
  • nonresponse)
  • - Or responded initially but then lost response with continued therapy (ie, secondary
  • nonresponse)
  • - Or were intolerant to the medication
  • - Have screening laboratory test results within protocol-specified parameters.
  • Exclusion Criteria:
  • - Patients who have had any kind of bowel resection within 6 months
  • - Are pregnant or planning pregnancy (both men and women) while enrolled in the study
  • or for 20 weeks after receiving study agent
  • - Patients who have received infliximab, adalimumab or certolizumab pegol < = 8 weeks
  • before the first administration of study drug
  • - Patients with certain complications of Crohn's disease that would make it hard to
  • assess response to study drug
  • - Patients with a history of or ongoing chronic or recurrent infectious disease
  • - Patients who have previously received a biologic agent targeting IL-12 or IL-23,
  • including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Research Site
Bristol Royal Hospital
Southampton General Hospital
Gloucestershire Royal Hospital
1237.19.44003 Boehringer Ingelheim Investigational Site
South Shields
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Hungary, Iceland, Ireland, Israel, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Serbia, South Africa, Spain, United Kingdom, United States
Scientific Title
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)
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
Janssen Research & Development, LLC
Key Dates

Recruitment Start Date

Jul 2011

Recruitment End Date

Jun 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

07 Jun 2011

Last Updated

01 Jul 2015