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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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.
Timepoint [1] 0 0
Baseline to Week 6
Secondary outcome [1] 0 0
Number of Participants With Clinical Remission at Week 6 - As measured by a CDAI score of < 150 points.
Timepoint [1] 0 0
Baseline to Week 6
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline to Week 4
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline to Week 8
Secondary outcome [4] 0 0
Number of Participants With Clinical Remission at Week 8 - As measured by a CDAI score of < 150 points.
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) - As measured by a CDAI score of < 150 points.
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) - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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- Adelaide
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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
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.
Trial website
https://clinicaltrials.gov/show/NCT00771667
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

Summary results
Other publications