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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00771667




Registration number
NCT00771667
Ethics application status
Date submitted
10/10/2008
Date registered
13/10/2008
Date last updated
1/04/2013

Titles & IDs
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
Secondary ID [1] 0 0
C0743T26
Secondary ID [2] 0 0
CR015238
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo (IP)
Treatment: Drugs - Ustekinumab 1mg/kg (IP)
Treatment: Drugs - Ustekinumab 3 mg/kg (IP)
Treatment: Drugs - Ustekinumab 6 mg/kg (IP)
Treatment: Drugs - Placebo IV - Responder - Placebo SC (MP)
Treatment: Drugs - Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)
Treatment: Drugs - Ustekinumab IV - Responder - Placebo SC (MP)
Treatment: Drugs - Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)
Treatment: Drugs - Ustekinumab IV - Nonresponder - Placebo SC (MP)
Treatment: Drugs - Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

Placebo comparator: Placebo (IP) -

Experimental: Ustekinumab 1mg/kg (IP) -

Experimental: Ustekinumab 3 mg/kg (IP) -

Experimental: Ustekinumab 6 mg/kg (IP) -

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

Placebo comparator: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC -

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

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

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

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


Treatment: Drugs: Placebo (IP)
Induction phase (Week 0-8) (IP) - Placebo IV group

Treatment: Drugs: Ustekinumab 1mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group

Treatment: Drugs: Ustekinumab 3 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group

Treatment: Drugs: Ustekinumab 6 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group

Treatment: Drugs: Placebo 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

Treatment: Drugs: Placebo 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

Treatment: Drugs: Ustekinumab 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

Treatment: Drugs: Ustekinumab 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

Treatment: Drugs: Ustekinumab 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

Treatment: Drugs: Ustekinumab 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Response at Week 6
Timepoint [1] 0 0
Baseline to Week 6
Secondary outcome [1] 0 0
Number of Participants With Clinical Remission at Week 6
Timepoint [1] 0 0
Baseline to Week 6
Secondary outcome [2] 0 0
Number of Participants With Clinical Response at Week 4
Timepoint [2] 0 0
Baseline to Week 4
Secondary outcome [3] 0 0
Number of Participants With Clinical Response at Week 8
Timepoint [3] 0 0
Baseline to Week 8
Secondary outcome [4] 0 0
Number of Participants With Clinical Remission at Week 8
Timepoint [4] 0 0
Baseline to Week 8
Secondary outcome [5] 0 0
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)
Timepoint [5] 0 0
Baseline to Week 22
Secondary outcome [6] 0 0
Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)
Timepoint [6] 0 0
Baseline to Week 22

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
526
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bankstown
Recruitment hospital [3] 0 0
- Bedford Park
Recruitment hospital [4] 0 0
- Box Hill
Recruitment hospital [5] 0 0
- Concord
Recruitment hospital [6] 0 0
- East Melbourne
Recruitment hospital [7] 0 0
- Fitzroy
Recruitment hospital [8] 0 0
- Frankston
Recruitment hospital [9] 0 0
- Fremantle
Recruitment hospital [10] 0 0
- Garran
Recruitment hospital [11] 0 0
- Herston
Recruitment hospital [12] 0 0
- Parkville
Recruitment hospital [13] 0 0
- Prahran
Recruitment hospital [14] 0 0
- South Brisbane
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Bankstown
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- Bedford Park
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- Box Hill
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- Concord
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- East Melbourne
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- Fremantle
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- Garran
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- Herston
Recruitment postcode(s) [12] 0 0
- Parkville
Recruitment postcode(s) [13] 0 0
- Prahran
Recruitment postcode(s) [14] 0 0
- South Brisbane
Recruitment outside Australia
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Alabama
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Arizona
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Norwich
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Nottinghamshirecc

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Centocor, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Centocor, Inc. Clinical Trial
Address 0 0
Centocor, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00771667