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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00771667
• Date of registration: 10/10/2008
• Prospective Registration: Yes
• Primary sponsor: Centocor, Inc.
• Public title: 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
• Scientific title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy
• Date of first enrolment: December 2008
• Target sample size: 526
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00771667
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Canada, France, Germany, Israel, Netherlands, New Zealand, Spain, United Kingdom, United States

Contacts

• Name: Centocor, Inc. Clinical Trial
• Affiliation: Centocor, Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Ustekinumab 3 mg/kg (IP)

Drug: Ustekinumab 6 mg/kg (IP)

Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)

Drug: Placebo (IP)

Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP)

Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)

Drug: Placebo IV - Responder - Placebo SC (MP)

Drug: Ustekinumab IV - Responder - Placebo SC (MP)

Drug: Ustekinumab 1mg/kg (IP)

Primary Outcome(s)

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

Secondary Outcome(s)

Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6) [Time Frame: Baseline to Week 22]

Number of Participants With Clinical Remission at Week 6 [Time Frame: Baseline to Week 6]

Number of Participants With Clinical Remission at Week 8 [Time Frame: Baseline to Week 8]

Number of Participants With Clinical Response at Week 4 [Time Frame: Baseline to Week 4]

Number of Participants With Clinical Response at Week 8 [Time Frame: Baseline to Week 8]

Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6) [Time Frame: Baseline to Week 22]

Secondary ID(s)

C0743T26

CR015238

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/07/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00771667