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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01369342




Registration number
NCT01369342
Ethics application status
Date submitted
7/06/2011
Date registered
8/06/2011
Date last updated
6/01/2017

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
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 (UNITI-2)
Secondary ID [1] 0 0
CNTO1275CRD3002
Secondary ID [2] 0 0
CR018418
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Inflammatory Bowel Disease 0 0
IBD 0 0
Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Group 1: Placebo
Treatment: Drugs - Group 2 ustekinumab 130 mg
Treatment: Drugs - Group 3: ustekinumab approximately 6 mg/kg

Placebo Comparator: Placebo IV - Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.

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.

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).


Treatment: Drugs: Group 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.

Treatment: Drugs: Group 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.

Treatment: Drugs: 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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Response at Week 6
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Number of Participants in Clinical Remission at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Number of Participants in Clinical Response at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6
Timepoint [3] 0 0
Week 6
Secondary outcome [4] 0 0
Number of Participants With CDAI 70 Point Response at Week 3
Timepoint [4] 0 0
Week 3

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
640
Recruitment in Australia
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- Parkville
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- Garran
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- Liverpool
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- Malvern
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- Parkville
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Serbia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study (UNITI-2) will compare the effects (both positive and negative) of an initial
treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely
active Crohn's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01369342
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01369342