CompletedNCT00771667Updated Apr 1, 2013Results posted

A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

A Phase 2 interventional study of Placebo (IP) and Ustekinumab 1mg/kg (IP) in Crohn's Disease, sponsored by Centocor, Inc.. Completed at 178 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-01.

Sponsored by Centocor, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 526
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

Read the detailed description

In Crohn's disease there is inflammation (changes in body tissue which normally happen during injury or infection) and or ulceration (open sores) in the intestines.This occurs because the immune system (the part of the body that fights off infection) has an abnormal and overactive response against the intestine and bowel tissues of the body. Crohn's disease is usually treated with medications that either directly decrease inflammation or decrease the general activity of the immune system to improve the diarrhea, abdominal pain, and other symptoms of Crohn's Disease. Ustekinumab antibodies (natural substances made by your immune system to stick to and help remove foreign materials in your body that cause diseases) have been created to stick to and block the activity of two of the immune substances thought to cause abnormal inflammation of Crohn's disease. Patients who are eligible and who have received Remicade, Humira, or Cimzia and failed or been intolerant to one of these drugs will be randomized to either active drug (ustekinumab) or placebo. All patients will be randomized (like flipping a coin) at week 0 to be in one of 4 groups. At week 0 the study drug will be given by IV administration and at weeks 8 and 16 by subcutaneous injection. There will be 11 study visits in total and the study will continue until week 36. Blood and stool samples will be collected and studied, questionnaires to check on how you are doing in terms of your disease will be completed, an Electrocardiogram (EKG) obtained, safety evaluations conducted and diary cards distributed to be completed during the entire study. One of 4 groups: Grp 1-placebo, Grp 2-active drug 1mg/kg IV, Grp 3-active drug 3mg/kg IV, Grp 4-active drug 6mg/kg IV. Based on the clinical response status at Week 6, patients from Grps 2, 3 and 4 will be re-randomized at week 8 to receive either placebo or 90 mg SC at both weeks 8 and 16 and patients from Grp 1 will receive placebo at Week 8 and Week 16 or a 270 mg SC injection at Week 8 and 90 mg SC at Week 16.

Conditions studied

Crohn's Disease

Browse trials for

Crohn Disease 1,880

Keywords

Interleukin-12
Inflammation
Research study
Ustekinumab
CNTO1275
Interleukin-23

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 526 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration
Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment of Crohn's disease
Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of Crohn's disease
Must be 18 years of age or older
Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI > =220 and \< =450).

Exclusion criteria

Exclusion Criteria:

Patients who have had any kind of bowel resection, diversions or placement of a stoma within 6 months
Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study or within 1 year after receiving study agent
Patients who have received Remicade, Humira or Cimzia \< =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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 526 participants (actual)

Study arms

Placebo comparator
Placebo (IP)
Drug: Placebo (IP)
Experimental
Ustekinumab 1mg/kg (IP)
Drug: Ustekinumab 1mg/kg (IP)
Experimental
Ustekinumab 3 mg/kg (IP)
Drug: Ustekinumab 3 mg/kg (IP)
Experimental
Ustekinumab 6 mg/kg (IP)
Drug: Ustekinumab 6 mg/kg (IP)
Placebo comparator
Placebo IV - Responder - Placebo SC (MP)
Drug: Placebo IV - Responder - Placebo SC (MP)
Placebo comparator
Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC
Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)
Placebo comparator
Ustekinumab IV - Responder - Placebo SC (MP)
Drug: Ustekinumab IV - Responder - Placebo SC (MP)
Experimental
Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)
Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)
Placebo comparator
Ustekinumab IV - Nonresponder - Placebo SC (MP)
Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP)
Experimental
Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)
Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

Interventions

DrugPlacebo (IP)
Induction phase (Week 0-8) (IP) - Placebo IV group
DrugUstekinumab 1mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group
DrugUstekinumab 3 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
DrugUstekinumab 6 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
DrugPlacebo IV - Responder - Placebo SC (MP)
Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16
DrugPlacebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)
Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
DrugUstekinumab IV - Responder - Placebo SC (MP)
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16
DrugUstekinumab IV - Responder - Ustekinumab 90mg SC (MP)
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
DrugUstekinumab IV - Nonresponder - Placebo SC (MP)
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Placebo SC at Week 8 and Week 16
DrugUstekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16

What researchers measure

Primary outcomes

Number of Participants With Clinical Response at Week 6
As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.
Time frame: Baseline to Week 6

Secondary outcomes

Number of Participants With Clinical Remission at Week 6
As measured by a CDAI score of \< 150 points.
Time frame: Baseline to Week 6
Number of Participants With Clinical Response at Week 4
As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.
Time frame: Baseline to Week 4
Number of Participants With Clinical Response at Week 8
As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.
Time frame: Baseline to Week 8
Number of Participants With Clinical Remission at Week 8
As measured by a CDAI score of \< 150 points.
Time frame: Baseline to Week 8
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)
As measured by a CDAI score of \< 150 points.
Time frame: Baseline to Week 22
Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)
As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.
Time frame: Baseline to Week 22

Results

Posted Jul 27, 2012

Participant flow

Induction Phase

Participant flow — Induction Phase
Milestone	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)
Started	132	131	132	131
Completed	113	121	120	123
Not completed	19	10	12	8
Withdrew: Adverse event	5	2	4	1
Withdrew: Lack of efficacy	9	2	4	3
Withdrew: Lost to follow-up	1	0	1	0
Withdrew: Other	4	6	3	4

Maintenance Phase

Participant flow — Maintenance Phase
Milestone	Placebo IV -> Responder -> Placebo SC (MP)	Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)	Ustekinumab IV -> Responder -> Placebo SC (MP)	Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)	Ustekinumab IV -> Nonresponder -> Placebo SC (MP)	Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)
Started	28	85	73	72	110	109
Completed	26	78	63	67	88	92
Not completed	2	7	10	5	22	17
Withdrew: Adverse event	1	3	5	1	8	7
Withdrew: Lack of efficacy	1	3	3	2	11	7
Withdrew: Other	0	1	2	2	3	3

Outcome measures

PrimaryNumber of Participants With Clinical Response at Week 6

As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.

Time frame:: Baseline to Week 6
Reported as:: Number · Participants

Number of Participants With Clinical Response at Week 6
Participants	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)
Number of Participants With Clinical Response at Week 6	31	48	45	52

Statistical analysis

Placebo (IP) vs Ustekinumab 6 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.005 (A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.)The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 3 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.057 (A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.)The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 1 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.021 (A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.)The CMH test is controlling for anti-TNF status.

SecondaryNumber of Participants With Clinical Remission at Week 6

As measured by a CDAI score of \< 150 points.

Time frame:: Baseline to Week 6
Reported as:: Number · Participants

Number of Participants With Clinical Remission at Week 6
Participants	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)
Number of Participants With Clinical Remission at Week 6	14	21	21	16

Statistical analysis

Placebo (IP) vs Ustekinumab 6 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.682The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 3 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.206The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 1 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.196The CMH test is controlling for anti-TNF status.

SecondaryNumber of Participants With Clinical Response at Week 4

As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.

Time frame:: Baseline to Week 4
Reported as:: Number · Participants

Number of Participants With Clinical Response at Week 4
Participants	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)
Number of Participants With Clinical Response at Week 4	22	36	49	40

Statistical analysis

Placebo (IP) vs Ustekinumab 6 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.008The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 3 mg/kg (IP) · Cochran-Mantel-Haenszel · p = <0.001The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 1 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.035The CMH test is controlling for anti-TNF status.

SecondaryNumber of Participants With Clinical Response at Week 8

Time frame:: Baseline to Week 8
Reported as:: Number · Participants

Number of Participants With Clinical Response at Week 8
Participants	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)
Number of Participants With Clinical Response at Week 8	23	42	42	57

Statistical analysis

Placebo (IP) vs Ustekinumab 6 mg/kg (IP) · Cochran-Mantel-Haenszel · p = <0.001The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 3 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.007The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 1 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.006The CMH test is controlling for anti-TNF status.

SecondaryNumber of Participants With Clinical Remission at Week 8

As measured by a CDAI score of \< 150 points.

Time frame:: Baseline to Week 8
Reported as:: Number · Participants

Number of Participants With Clinical Remission at Week 8
Participants	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)
Number of Participants With Clinical Remission at Week 8	14	23	24	24

Statistical analysis

Placebo (IP) vs Ustekinumab 6 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.074The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 3 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.081The CMH test is controlling for anti-TNF status.
Placebo (IP) vs Ustekinumab 1 mg/kg (IP) · Cochran-Mantel-Haenszel · p = 0.105The CMH test is controlling for anti-TNF status.

SecondaryNumber of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)

As measured by a CDAI score of \< 150 points.

Time frame:: Baseline to Week 22
Reported as:: Number · Participants

Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)
Participants	Placebo SC	Ustekinumab 90 mg SC
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)	20	30

Statistical analysis

Placebo SC vs Ustekinumab 90 mg SC · Cochran-Mantel-Haenszel · p = 0.029 (Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.)The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.

SecondaryNumber of Participants With Clinical Response at Week 22 (Among Responders From Week 6)

Time frame:: Baseline to Week 22
Reported as:: Number · Participants

Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)
Participants	Placebo SC	Ustekinumab 90 mg SC
Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)	31	50

Statistical analysis

Placebo SC vs Ustekinumab 90 mg SC · Cochran-Mantel-Haenszel · p = <0.001The CMH test is controlling for induction dose and clinical remission status at Week 6.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo (IP)	—	11/132 (8.3%)	53/132 (40.2%)
Ustekinumab 1 mg/kg (IP)	—	6/130 (4.6%)	51/130 (39.2%)
Ustekinumab 3 mg/kg (IP)	—	8/133 (6%)	50/133 (37.6%)
Ustekinumab 6 mg/kg (IP)	—	9/131 (6.9%)	47/131 (35.9%)
Placebo IV -> Responder -> Placebo SC (MP)	—	8/28 (28.6%)	18/28 (64.3%)
Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)	—	16/85 (18.8%)	47/85 (55.3%)
Ustekinumab IV -> Responder -> Placebo SC (MP)	—	12/73 (16.4%)	39/73 (53.4%)
Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)	—	9/72 (12.5%)	39/72 (54.2%)
Ustekinumab IV -> Nonresponder -> Placebo SC (MP)	—	21/110 (19.1%)	64/110 (58.2%)
Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)	—	22/109 (20.2%)	52/109 (47.7%)

Most frequent serious events

Showing 10 of 83

Most frequent serious events
Event	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)	Placebo IV -> Responder -> Placebo SC (MP)	Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)	Ustekinumab IV -> Responder -> Placebo SC (MP)	Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)	Ustekinumab IV -> Nonresponder -> Placebo SC (MP)	Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)
Crohn's diseaseGastrointestinal disorders	5/132	2/130	4/133	2/131	3/28	8/85	7/73	4/72	8/110	10/109
ConstipationGastrointestinal disorders	1/132	0/130	0/133	0/131	1/28	0/85	0/73	0/72	0/110	0/109
Perirectal abscessInfections and infestations	0/132	0/130	0/133	0/131	1/28	0/85	0/73	0/72	0/110	0/109
Decreased appetiteMetabolism and nutrition disorders	0/132	0/130	0/133	0/131	1/28	1/85	0/73	0/72	0/110	0/109
Intervertebral disc disorderMusculoskeletal and connective tissue disorders	0/132	0/130	0/133	0/131	1/28	0/85	0/73	0/72	0/110	0/109
Ovarian cystReproductive system and breast disorders	0/132	0/130	0/133	0/131	1/28	0/85	0/73	0/72	0/110	0/109
Abdominal painGastrointestinal disorders	0/132	0/130	1/133	0/131	0/28	1/85	1/73	0/72	1/110	3/109
Abdominal abscessInfections and infestations	0/132	0/130	0/133	0/131	0/28	0/85	0/73	0/72	2/110	0/109
Anal abscessInfections and infestations	2/132	0/130	0/133	1/131	0/28	0/85	0/73	1/72	0/110	0/109
ProctalgiaGastrointestinal disorders	0/132	1/130	0/133	0/131	0/28	0/85	0/73	1/72	0/110	0/109

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)	Placebo IV -> Responder -> Placebo SC (MP)	Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)	Ustekinumab IV -> Responder -> Placebo SC (MP)	Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)	Ustekinumab IV -> Nonresponder -> Placebo SC (MP)	Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)
Crohn's diseaseGastrointestinal disorders	8/132	5/130	3/133	3/131	10/28	9/85	16/73	7/72	19/110	10/109
CoughRespiratory, thoracic and mediastinal disorders	3/132	6/130	4/133	3/131	4/28	2/85	4/73	1/72	3/110	4/109
NasopharyngitisInfections and infestations	6/132	7/130	7/133	8/131	1/28	12/85	6/73	5/72	0/110	6/109
Abdominal painGastrointestinal disorders	9/132	5/130	8/133	7/131	1/28	4/85	8/73	3/72	10/110	7/109
ArthralgiaMusculoskeletal and connective tissue disorders	4/132	8/130	8/133	6/131	2/28	7/85	3/73	5/72	12/110	5/109
NauseaGastrointestinal disorders	11/132	9/130	1/133	8/131	3/28	8/85	5/73	7/72	8/110	4/109
HeadacheNervous system disorders	8/132	8/130	9/133	13/131	1/28	5/85	4/73	4/72	7/110	8/109
PyrexiaGeneral disorders	3/132	5/130	4/133	3/131	1/28	8/85	2/73	1/72	9/110	6/109
VomitingGastrointestinal disorders	3/132	2/130	3/133	3/131	0/28	2/85	4/73	6/72	6/110	5/109
Upper respiratory tract infectionInfections and infestations	0/132	5/130	4/133	5/131	2/28	2/85	4/73	6/72	7/110	7/109

Baseline characteristics

Age Continuous
Age Continuous(years)	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)	Total
Mean	39.5 ± 13.05	38.8 ± 11.95	38.2 ± 12.63	39.4 ± 13.21	39 ± 12.69

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo (IP)	Ustekinumab 1 mg/kg (IP)	Ustekinumab 3 mg/kg (IP)	Ustekinumab 6 mg/kg (IP)	Total
Female	68	83	75	83	309
Male	64	48	57	48	217

Study locations

178 sites

Mobile, Alabama, United States
Scottsdale, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Roseville, California, United States
San Carlos, California, United States
San Francisco, California, United States
Englewood, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Hamden, Connecticut, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Panama City, Florida, United States
Pembroke Pines, Florida, United States
Port Charlotte, Florida, United States
Port Orange, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Newnan, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Indianapolis, Indiana, United States
Clive, Iowa, United States
Pratt, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
Detroit, Michigan, United States
Troy, Michigan, United States
Rochester, Minnesota, United States
Ocean Springs, Mississippi, United States
Mexico, Missouri, United States
Lebanon, New Hampshire, United States
Egg Harbor, New Jersey, United States
Great Neck, New York, United States
New York, New York, United States
Ny, New York, United States
Poughkeepsie, New York, United States
Setauket, New York, United States
Stony Brook, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Kinston, North Carolina, United States
New Bern, North Carolina, United States
Raleigh, North Carolina, United States
Beavercreek, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Lewisville, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Bellevue, Washington, United States
Lakewood, Washington, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Madison, Wisconsin, United States
Adelaide, Australia
Bankstown, Australia
Bedford Park, Australia
Box Hill, Australia
Concord, Australia
East Melbourne, Australia
Fitzroy, Australia
Frankston, Australia
Fremantle, Australia
Garran, Australia
Herston, Australia

Showing the first 100 of 178 sites across 12 countries.

References and documents

Publications

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. PubMed 36150926 ↗
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 Jun;42(6):809. doi: 10.1007/s40264-019-00816-3. PubMed 30739254 ↗
Di Narzo AF, Telesco SE, Brodmerkel C, Argmann C, Peters LA, Li K, Kidd B, Dudley J, Cho J, Schadt EE, Kasarskis A, Dobrin R, Hao K. High-Throughput Characterization of Blood Serum Proteomics of IBD Patients with Respect to Aging and Genetic Factors. PLoS Genet. 2017 Jan 27;13(1):e1006565. doi: 10.1371/journal.pgen.1006565. eCollection 2017 Jan. PubMed 28129359 ↗
Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, Ghosh S, de Villiers WJ, Panaccione R, Greenberg G, Schreiber S, Lichtiger S, Feagan BG; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012 Oct 18;367(16):1519-28. doi: 10.1056/NEJMoa1203572. PubMed 23075178 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00771667
Lead sponsor: Centocor, Inc.
First posted: Oct 13, 2008
Start date: Dec 2008
Primary completion: May 2010
Completion: Dec 2010
Results posted: Jul 27, 2012
Last update: Apr 1, 2013

Study contacts

Centocor, Inc. Clinical Trial

study director · Centocor, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

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