Phase 2 N=526 Randomized Double-blind Treatment

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

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00771667 ↗

Enrolled (actual)

526

Serious AEs

12.2%

Results posted

Jul 2012

Primary outcome: Primary: Number of Participants With Clinical Response at Week 6 — 31; 48; 45; 52 Participants — p=0.005

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (IP) (Drug); Ustekinumab 1mg/kg (IP) (Drug); Ustekinumab 3 mg/kg (IP) (Drug); Ustekinumab 6 mg/kg (IP) (Drug); Placebo IV - Responder - Placebo SC (MP) (Drug); Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP) (Drug); Ustekinumab IV - Responder - Placebo SC (MP) (Drug); Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP) (Drug); Ustekinumab IV - Nonresponder - Placebo SC (MP) (Drug); Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Centocor, Inc.
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Response at Week 6	31; 48; 45; 52	0.005 sig
SECONDARY Number of Participants With Clinical Remission at Week 6	14; 21; 21; 16	0.682
SECONDARY Number of Participants With Clinical Response at Week 4	22; 36; 49; 40	0.008 sig
SECONDARY Number of Participants With Clinical Response at Week 8	23; 42; 42; 57	<0.001 sig
SECONDARY Number of Participants With Clinical Remission at Week 8	14; 23; 24; 24	0.074
SECONDARY Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)	20; 30	0.029 sig
SECONDARY Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)	31; 50	<0.001 sig

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.

Eligibility Criteria

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00771667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.