COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01369329




Registration number
NCT01369329
Ethics application status
Date submitted
7/06/2011
Date registered
8/06/2011
Date last updated
7/12/2016

Titles & IDs
Public title
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)
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)
Secondary ID [1] 0 0
CNTO1275CRD3001
Secondary ID [2] 0 0
CR018415
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
IBD 0 0
Colitis 0 0
Inflammatory Bowel Disease 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

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

Placebo Comparator: 001 - Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.

Experimental: 002 - Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.

Experimental: 003 - 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 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).

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

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 - Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index 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 CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Timepoint [1] 0 0
Baseline and Week 6
Secondary outcome [1] 0 0
Number of Participants in Clinical Remission at Week 8 - Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.
Timepoint [1] 0 0
Baseline and Week 8
Secondary outcome [2] 0 0
Number of Participants in Clinical Response at Week 8 - Clinical response at Week 8 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. 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 CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Timepoint [2] 0 0
Baseline and Week 8
Secondary outcome [3] 0 0
Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6 - 70-point response is defined as at least 70 points reduction in CDAI score. 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.
Timepoint [3] 0 0
Baseline and Week 6
Secondary outcome [4] 0 0
Number of Participants With CDAI 70-point Response at Week 3 - 70-point response is defined as at least 70 points reduction in CDAI score. 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.
Timepoint [4] 0 0
Baseline and 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'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.
Minimum age
18 Years
Maximum age
No limit
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Central Queensland M C
Recruitment hospital [4] 0 0
- Concord
Recruitment hospital [5] 0 0
- Garran
Recruitment hospital [6] 0 0
- Liverpool
Recruitment hospital [7] 0 0
- Malvern
Recruitment hospital [8] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Central Queensland M C
Recruitment postcode(s) [4] 0 0
- Concord
Recruitment postcode(s) [5] 0 0
- Garran
Recruitment postcode(s) [6] 0 0
- Liverpool
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Austria
State/province [34] 0 0
Innsbruck
Country [35] 0 0
Austria
State/province [35] 0 0
St Poelten
Country [36] 0 0
Austria
State/province [36] 0 0
Wien
Country [37] 0 0
Belgium
State/province [37] 0 0
Brussel
Country [38] 0 0
Belgium
State/province [38] 0 0
Leuven
Country [39] 0 0
Belgium
State/province [39] 0 0
Liege
Country [40] 0 0
Brazil
State/province [40] 0 0
Rio De Janeiro
Country [41] 0 0
Canada
State/province [41] 0 0
Alberta
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
State/province [43] 0 0
Manitoba
Country [44] 0 0
Canada
State/province [44] 0 0
Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Usti Nad Labem
Country [48] 0 0
Denmark
State/province [48] 0 0
Herlev
Country [49] 0 0
Denmark
State/province [49] 0 0
Silkeborg
Country [50] 0 0
France
State/province [50] 0 0
Amiens Cedex 1
Country [51] 0 0
France
State/province [51] 0 0
Caen
Country [52] 0 0
France
State/province [52] 0 0
Lille
Country [53] 0 0
France
State/province [53] 0 0
Marseille
Country [54] 0 0
France
State/province [54] 0 0
Nantes Cedex 1
Country [55] 0 0
France
State/province [55] 0 0
Paris Cedex 18
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Pessac
Country [58] 0 0
France
State/province [58] 0 0
Reims
Country [59] 0 0
France
State/province [59] 0 0
Rouen
Country [60] 0 0
France
State/province [60] 0 0
Toulouse
Country [61] 0 0
Germany
State/province [61] 0 0
Berlin
Country [62] 0 0
Germany
State/province [62] 0 0
Erlangen
Country [63] 0 0
Germany
State/province [63] 0 0
Essen
Country [64] 0 0
Germany
State/province [64] 0 0
Frankfurt
Country [65] 0 0
Germany
State/province [65] 0 0
Freiburg
Country [66] 0 0
Germany
State/province [66] 0 0
Halle
Country [67] 0 0
Germany
State/province [67] 0 0
Hamburg
Country [68] 0 0
Germany
State/province [68] 0 0
Hannover
Country [69] 0 0
Germany
State/province [69] 0 0
Heidelberg
Country [70] 0 0
Germany
State/province [70] 0 0
Jena
Country [71] 0 0
Germany
State/province [71] 0 0
Kiel
Country [72] 0 0
Germany
State/province [72] 0 0
Lÿneburg
Country [73] 0 0
Germany
State/province [73] 0 0
Mannheim
Country [74] 0 0
Germany
State/province [74] 0 0
Minden
Country [75] 0 0
Germany
State/province [75] 0 0
München
Country [76] 0 0
Germany
State/province [76] 0 0
Münster
Country [77] 0 0
Germany
State/province [77] 0 0
Regensburg
Country [78] 0 0
Germany
State/province [78] 0 0
Tübingen
Country [79] 0 0
Germany
State/province [79] 0 0
Ulm
Country [80] 0 0
Hungary
State/province [80] 0 0
Szekszard
Country [81] 0 0
Iceland
State/province [81] 0 0
Akureyri
Country [82] 0 0
Iceland
State/province [82] 0 0
Reykjavik
Country [83] 0 0
Ireland
State/province [83] 0 0
Dublin 9
Country [84] 0 0
Ireland
State/province [84] 0 0
Dublin
Country [85] 0 0
Israel
State/province [85] 0 0
Jerusalem
Country [86] 0 0
Israel
State/province [86] 0 0
Tel Hashomer
Country [87] 0 0
Japan
State/province [87] 0 0
Chikushino
Country [88] 0 0
Japan
State/province [88] 0 0
Fukuoka
Country [89] 0 0
Japan
State/province [89] 0 0
Hamamatsu
Country [90] 0 0
Japan
State/province [90] 0 0
Kagoshima
Country [91] 0 0
Japan
State/province [91] 0 0
Nishinomiya
Country [92] 0 0
Japan
State/province [92] 0 0
Ohtsu
Country [93] 0 0
Japan
State/province [93] 0 0
Oita
Country [94] 0 0
Japan
State/province [94] 0 0
Osaka
Country [95] 0 0
Japan
State/province [95] 0 0
Sakura
Country [96] 0 0
Japan
State/province [96] 0 0
Sapporo
Country [97] 0 0
Japan
State/province [97] 0 0
Tokyo
Country [98] 0 0
Japan
State/province [98] 0 0
Yokkaichi
Country [99] 0 0
Korea, Republic of
State/province [99] 0 0
Seoul
Country [100] 0 0
Netherlands
State/province [100] 0 0
Amsterdam
Country [101] 0 0
Netherlands
State/province [101] 0 0
Maastricht
Country [102] 0 0
Netherlands
State/province [102] 0 0
Rotterdam
Country [103] 0 0
New Zealand
State/province [103] 0 0
Auckland
Country [104] 0 0
New Zealand
State/province [104] 0 0
Christchurch
Country [105] 0 0
New Zealand
State/province [105] 0 0
Grafton
Country [106] 0 0
New Zealand
State/province [106] 0 0
Hamilton
Country [107] 0 0
Poland
State/province [107] 0 0
Krakow
Country [108] 0 0
Poland
State/province [108] 0 0
Lodz
Country [109] 0 0
Serbia
State/province [109] 0 0
Belgrade
Country [110] 0 0
Serbia
State/province [110] 0 0
Nis
Country [111] 0 0
South Africa
State/province [111] 0 0
Cape Town
Country [112] 0 0
South Africa
State/province [112] 0 0
Overport
Country [113] 0 0
Spain
State/province [113] 0 0
Madrid
Country [114] 0 0
Spain
State/province [114] 0 0
Sagunto
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Birmingham
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Brighton
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Bristol
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Cambridge
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Cardiff
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Exeter
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Gloucester
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Harrow
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Liverpool
Country [124] 0 0
United Kingdom
State/province [124] 0 0
London
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Manchester
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Norwich
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Nottinghamshirecc
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Oxford
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Shropshire
Country [130] 0 0
United Kingdom
State/province [130] 0 0
South Shields
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Southampton

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-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).
Trial website
https://clinicaltrials.gov/show/NCT01369329
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
Other publications