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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)

Phase 3
18 Years
Open (Enrolling)
Crohn's Disease, IBD, Colitis, Inflammatory Bowel Disease

Thank you

Trial Information

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)

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).

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

- 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

- Or responded initially but then lost response with continued therapy (ie, secondary

- 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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Clinical Response

Outcome Description:

The number of patients in clinical response, as measured by the reduction from baseline in the Crohn's Disease Activity Index (CDAI), which is assessed by collecting information on extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.

Outcome Time Frame:

Week 6

Safety Issue:


Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

July 2013

Related Keywords:

  • Crohn's Disease
  • IBD
  • Colitis
  • Inflammatory Bowel Disease
  • ustekinumab
  • moderately to severely active Crohn's Disease
  • tumor necrosis factor, Stelara
  • Crohn
  • Crohn's
  • IBD
  • Colitis
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Intestinal Diseases



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