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)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT01369329

First received: June 7, 2011

Last updated: October 14, 2016

Last verified: October 2016

History of Changes

Results First Received: August 1, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Crohn's Disease IBD Colitis Inflammatory Bowel Disease
Interventions:	Drug: Group 2 ustekinumab 130 mg Drug: Group 3: ustekinumab approximately 6 mg/kg Drug: Group 1: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 769 participants were randomly assigned to receive study agent. The analyses (efficacy) was based on the 741 participants who were randomized after the study was restarted.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In November 2011, due to stability issue with the batch of the intravenous (IV) drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Later study was restarted with 90 milligram per milliliter (mg/ml).

Reporting Groups

	Description
Placebo	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 Milligram (mg)	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.

Participant Flow: Overall Study

	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
STARTED	256	254	259
COMPLETED	244	243	245
NOT COMPLETED	12	11	14
Withdrawal by Subject	8	6	10
Lost to Follow-up	2	2	2
Unspecified	2	3	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 Milligram (mg)	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	Total
Overall Participants Analyzed [Units: Participants]	256	254	259	769

Age [Units: Years] Mean (Standard Deviation)	37.6 (11.86)	37.4 (11.74)	37.2 (12.57)	37.4 (12.05)

Gender [Units: Participants]
Female	135	153	152	440
Male	121	101	107	329

Region of Enrollment [Units: Participants]
Australia	6	7	8	21
Austria	0	0	6	6
Belgium	8	12	8	28
Brazil	2	0	1	3
Canada	10	21	21	52
Czech Republic	2	2	1	5
Germany	22	14	14	50
Denmark	1	3	2	6
Spain	0	0	2	2
France	17	21	29	67
United Kingdom	21	21	16	58
Hungary	1	1	2	4
Ireland	0	0	1	1
Israel	1	2	3	6
Italy	4	7	8	19
Japan	18	19	19	56
South Korea	1	0	2	3
Netherlands	9	9	14	32
New Zealand	1	1	0	2
Poland	4	3	4	11
Serbia	1	2	1	4
United States	126	108	97	331
South Africa	1	1	0	2

Outcome Measures

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1. Primary:

Number of Participants With Clinical Response at Week 6 [ Time Frame: Baseline and Week 6 ]

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2. Secondary:

Number of Participants in Clinical Remission at Week 8 [ Time Frame: Baseline and Week 8 ]

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3. Secondary:

Number of Participants in Clinical Response at Week 8 [ Time Frame: Baseline and Week 8 ]

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4. Secondary:

Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6 [ Time Frame: Baseline and Week 6 ]

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5. Secondary:

Number of Participants With CDAI 70-point Response at Week 3 [ Time Frame: Baseline and Week 3 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The global study was interrupted due to issues with the clinical supply.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact:

Name/Title: Vice President
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI–IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960.

Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT01369329 History of Changes
Other Study ID Numbers:	CR018415 CNTO1275CRD3001 ( Other Identifier: Janssen Research & Development, LLC ) 2010-022758-18 ( EudraCT Number )
Study First Received:	June 7, 2011
Results First Received:	August 1, 2016
Last Updated:	October 14, 2016

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