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)

• ClinicalTrials.gov Identifier: NCT01369329
• Recruitment Status: Completed
• First Posted: June 8, 2011
• Results First Posted: December 7, 2016
• Last Update Posted: December 7, 2016
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (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
• Enrollment: 769

Participant Flow

Recruitment Details	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	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).

Arm/Group Title	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Arm/Group Description	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.	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.
Period Title: Overall Study
Started	256	254	259
Completed	244	243	245
Not Completed	12	11	14
Reason Not Completed
Withdrawal by Subject	8	6	10
Lost to Follow-up	2	2	2
Other	2	3	2

Baseline Characteristics

Arm/Group Title		Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)	Total
Arm/Group Description		Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.	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 of all reporting groups
Overall Number of Baseline Participants		256	254	259	769
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	256 participants	254 participants	259 participants	769 participants
		37.6 (11.86)	37.4 (11.74)	37.2 (12.57)	37.4 (12.05)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	256 participants	254 participants	259 participants	769 participants
	Female	135 52.7%	153 60.2%	152 58.7%	440 57.2%
	Male	121 47.3%	101 39.8%	107 41.3%	329 42.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	256 participants	254 participants	259 participants	769 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

1. Primary Outcome

Title	Number of Participants With Clinical Response at Week 6
Description	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.
Time Frame	Baseline and Week 6

Outcome Measure Data

Analysis Population Description

Efficacy analyses set included all the participants who were randomized after the study was restarted.

Arm/Group Title	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Arm/Group Description:	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.	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.
Overall Number of Participants Analyzed	247	245	249
Measure Type: Number; Unit of Measure: participants
	53	84	84

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab 130 Milligram (mg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

2. Secondary Outcome

Title	Number of Participants in Clinical Remission at Week 8
Description	Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

Efficacy analyses set included all the participants who were randomized after the study was restarted.

Arm/Group Title	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Arm/Group Description:	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.	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.
Overall Number of Participants Analyzed	247	245	249
Measure Type: Number; Unit of Measure: participants
	18	39	52

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab 130 Milligram (mg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

3. Secondary Outcome

Title	Number of Participants in Clinical Response at Week 8
Description	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.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

Efficacy analyses set included all the participants who were randomized after the study was restarted.

Arm/Group Title	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Arm/Group Description:	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.	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.
Overall Number of Participants Analyzed	247	245	249
Measure Type: Number; Unit of Measure: participants
	50	82	94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab 130 Milligram (mg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Efficacy analyses set included all the participants who were randomized after the study was restarted.

Arm/Group Title	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Arm/Group Description:	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.	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.
Overall Number of Participants Analyzed	247	245	249
Measure Type: Number; Unit of Measure: participants
	75	113	109

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab 130 Milligram (mg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

5. Secondary Outcome

Title	Number of Participants With CDAI 70-point Response at Week 3
Description	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.
Time Frame	Baseline and Week 3

Outcome Measure Data

Analysis Population Description

Efficacy analyses set included all the participants who were randomized after the study was restarted.

Arm/Group Title	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Arm/Group Description:	Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.	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.
Overall Number of Participants Analyzed	247	245	249
Measure Type: Number; Unit of Measure: participants
	67	94	101

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab 130 Milligram (mg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
	Method	Cochran-Mantel-Haenszel chi-square test
	Comments	2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.

Adverse Events

Time Frame	Up to Week 8 for all participants (for participants who do not enter the maintenance study, adverse events will be collected up to 20 weeks after the study agent administration)
Adverse Event Reporting Description	One Participant who was randomized to the placebo group never received study agent and another participant who was randomized to the placebo group actually received ustekinumab and was analyzed in the 130 milligram (mg) ustekinumab group for safety.
Arm/Group Title	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
Arm/Group Description	Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.	Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.	Participants received 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.
All-Cause Mortality
	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	18/254 (7.09%)	14/255 (5.49%)	18/259 (6.95%)
Cardiac disorders
Atrial Fibrillation * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Cardiac Failure * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Intracardiac Thrombus * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Gastrointestinal disorders
Abdominal Pain * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Colonic Fistula * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Crohn's Disease * 1	10/254 (3.94%)	7/255 (2.75%)	5/259 (1.93%)
Dental Caries * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Diarrhoea * 1	2/254 (0.79%)	0/255 (0.00%)	0/259 (0.00%)
Gastric Ulcer Haemorrhage * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Large Intestine Perforation * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Small Intestinal Obstruction * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
General disorders
Pyrexia * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Hepatobiliary disorders
Cholangitis * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Immune system disorders
Hypersensitivity * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Infections and infestations
Abscess Intestinal * 1	0/254 (0.00%)	1/255 (0.39%)	1/259 (0.39%)
Anal Abscess * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Clostridial Infection * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Escherichia Sepsis * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Gastroenteritis Viral * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Infected Fistula * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Intervertebral Discitis * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Meningitis Listeria * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Pelvic Abscess * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Perineal Abscess * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Peritonitis * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Pneumonia Viral * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Postoperative Abscess * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Pyelonephritis * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Vulval Abscess * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Injury, poisoning and procedural complications
Road Traffic Accident * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Investigations
Blood Electrolytes Abnormal * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Metabolism and nutrition disorders
Dehydration * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Hypocalcaemia * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Hypokalaemia * 1	1/254 (0.39%)	1/255 (0.39%)	0/259 (0.00%)
Hypomagnesaemia * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Malnutrition * 1	1/254 (0.39%)	0/255 (0.00%)	0/259 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Renal and urinary disorders
Nephrolithiasis * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Reproductive system and breast disorders
Female Genital Tract Fistula * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Respiratory, thoracic and mediastinal disorders
Asthma * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Pulmonary Embolism * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
Vascular disorders
Lymphocele * 1	0/254 (0.00%)	0/255 (0.00%)	1/259 (0.39%)
Phlebitis Superficial * 1	0/254 (0.00%)	1/255 (0.39%)	0/259 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA Version 15
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	Ustekinumab 130 Milligram (mg)	Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	90/254 (35.43%)	95/255 (37.25%)	78/259 (30.12%)
Gastrointestinal disorders
Abdominal Pain * 1	14/254 (5.51%)	10/255 (3.92%)	14/259 (5.41%)
Crohn's Disease * 1	21/254 (8.27%)	8/255 (3.14%)	1/259 (0.39%)
Nausea * 1	18/254 (7.09%)	20/255 (7.84%)	15/259 (5.79%)
General disorders
Fatigue * 1	13/254 (5.12%)	6/255 (2.35%)	10/259 (3.86%)
Pyrexia * 1	14/254 (5.51%)	15/255 (5.88%)	15/259 (5.79%)
Infections and infestations
Nasopharyngitis * 1	14/254 (5.51%)	12/255 (4.71%)	12/259 (4.63%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	19/254 (7.48%)	28/255 (10.98%)	15/259 (5.79%)
Nervous system disorders
Headache * 1	22/254 (8.66%)	20/255 (7.84%)	20/259 (7.72%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA Version 15

Limitations and Caveats

The global study was interrupted due to issues with the clinical supply.

More Information

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.

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
• EMail: ClinicalTrialDisclosure@its.jnj.com

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

Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.

Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.

Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum In: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.

Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:

Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.

Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.

Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.

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. doi: 10.1056/NEJMoa1602773.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT01369329
• Other Study ID Numbers: CR018415; CNTO1275CRD3001 ( Other Identifier: Janssen Research & Development, LLC ); 2010-022758-18 ( EudraCT Number )
• First Submitted: June 7, 2011
• First Posted: June 8, 2011
• Results First Submitted: August 1, 2016
• Results First Posted: December 7, 2016
• Last Update Posted: December 7, 2016