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Download to PDF
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
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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
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Secondary ID [1]
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0
C0743T26
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Secondary ID [2]
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0
CR015238
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Clinical Response at Week 6
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 6
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Secondary outcome [1]
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Number of Participants With Clinical Remission at Week 6
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Assessment method [1]
0
0
As measured by a CDAI score of \< 150 points.
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Timepoint [1]
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Baseline to Week 6
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Secondary outcome [2]
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Number of Participants With Clinical Response at Week 4
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Assessment method [2]
0
0
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.
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Timepoint [2]
0
0
Baseline to Week 4
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Secondary outcome [3]
0
0
Number of Participants With Clinical Response at Week 8
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Assessment method [3]
0
0
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.
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Timepoint [3]
0
0
Baseline to Week 8
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Secondary outcome [4]
0
0
Number of Participants With Clinical Remission at Week 8
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Assessment method [4]
0
0
As measured by a CDAI score of \< 150 points.
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Timepoint [4]
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0
Baseline to Week 8
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Secondary outcome [5]
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0
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)
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Assessment method [5]
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0
As measured by a CDAI score of \< 150 points.
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Timepoint [5]
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Baseline to Week 22
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Secondary outcome [6]
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Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)
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Assessment method [6]
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0
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.
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Timepoint [6]
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Baseline to Week 22
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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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
526
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Recruitment in Australia
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- 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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- Garran
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- Herston
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- South Brisbane
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- 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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- Fitzroy
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- Herston
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- Parkville
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- Prahran
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- South Brisbane
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Recruitment outside Australia
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United Kingdom
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Edinburgh
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United Kingdom
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Harrow
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Norwich
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United Kingdom
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Nottinghamshirecc
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Centocor, Inc.
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00771667
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Trial related presentations / 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
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Centocor, Inc. Clinical Trial
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Centocor, Inc.
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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 not provided in
https://clinicaltrials.gov/study/NCT00771667
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