A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
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ClinicalTrials.gov Identifier: NCT01369342 |
Recruitment Status
:
Completed
First Posted
: June 8, 2011
Results First Posted
: January 6, 2017
Last Update Posted
: January 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease Inflammatory Bowel Disease IBD Colitis | Drug: Group 1: Placebo Drug: Group 2 ustekinumab 130 mg Drug: Group 3: ustekinumab approximately 6 mg/kg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 640 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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 (UNITI-2) |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo IV
Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
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Drug: Group 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.
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Experimental: Ustekinumab 130 milligram (mg)
Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
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Drug: Group 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
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Experimental: Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg)
Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.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).
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Drug: Group 3: ustekinumab approximately 6 mg/kg
Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.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).
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- Number of Participants With Clinical Response at Week 6 [ Time Frame: Week 6 ]Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
- Number of Participants in Clinical Remission at Week 8 [ Time Frame: Week 8 ]Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points.
- Number of Participants in Clinical Response at Week 8 [ Time Frame: Week 8 ]Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.
- Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6 [ Time Frame: Week 6 ]70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
- Number of Participants With CDAI 70 Point Response at Week 3 [ Time Frame: Week 3 ]70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
- Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369342

Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01369342 History of Changes |
Other Study ID Numbers: |
CR018418 CNTO1275CRD3002 ( Other Identifier: Janssen Research & Development, LLC ) 2010-022759-42 ( EudraCT Number ) |
First Posted: | June 8, 2011 Key Record Dates |
Results First Posted: | January 6, 2017 |
Last Update Posted: | January 6, 2017 |
Last Verified: | November 2016 |
Keywords provided by Janssen Research & Development, LLC:
ustekinumab moderately to severely active Crohn's Disease Stelara IBD |
colitis crohn UNITI Crohn's |
Additional relevant MeSH terms:
Crohn Disease Ustekinumab Colitis Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Colonic Diseases Pharmaceutical Solutions Dermatologic Agents |