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Health Condition(s) or Problem
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Crohn's Disease; IBD; Colitis; Inflammatory Bowel Disease
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Lay Summary
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This study (UNITI-1) will compare the effects (both positive and negative) of an initial
treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely
active Crohn's disease who have either failed or could not tolerate at least one
TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or
certolizumab pegol).
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or
ileocolitis, confirmed at some time in the past by radiography, histology, or
endoscopy
- Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index
(CDAI) score of >= 220 and <= 450
- Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for
the treatment of Crohn disease and did not respond initially (ie, primary
nonresponse)
- Or responded initially but then lost response with continued therapy (ie, secondary
nonresponse)
- Or were intolerant to the medication
- Have screening laboratory test results within protocol-specified parameters.
Exclusion Criteria:
- Patients who have had any kind of bowel resection within 6 months
- Are pregnant or planning pregnancy (both men and women) while enrolled in the study
or for 20 weeks after receiving study agent
- Patients who have received infliximab, adalimumab or certolizumab pegol < = 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
- Patients who have previously received a biologic agent targeting IL-12 or IL-23,
including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874).
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Who cannot enter the trial
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Inclusion Criteria:
- Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or
ileocolitis, confirmed at some time in the past by radiography, histology, or
endoscopy
- Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index
(CDAI) score of >= 220 and <= 450
- Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for
the treatment of Crohn disease and did not respond initially (ie, primary
nonresponse)
- Or responded initially but then lost response with continued therapy (ie, secondary
nonresponse)
- Or were intolerant to the medication
- Have screening laboratory test results within protocol-specified parameters.
Exclusion Criteria:
- Patients who have had any kind of bowel resection within 6 months
- Are pregnant or planning pregnancy (both men and women) while enrolled in the study
or for 20 weeks after receiving study agent
- Patients who have received infliximab, adalimumab or certolizumab pegol < = 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
- Patients who have previously received a biologic agent targeting IL-12 or IL-23,
including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874).
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What will happen
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Drug; Group 2 ustekinumab 130 mg; Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.; 002; Drug; Group 3: ustekinumab approximately 6 mg/kg; Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).; 003; Drug; Group 1: Placebo; Form=solution for injection, route=intravenous use, in a single dose.; 001
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Primary aim
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Clinical Response
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Secondary Aim
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Clinical remission; Week 8; No; The number of patients in clinical remission, as assessed by the CDAI.; Clinical improvement/response; Study visits through Week 8; No; The number of patients experiencing clinical response or improvement, as measured by the reduction from baseline in CDAI score.
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://pam.sylogent.com/cr/CR018415
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Recruitment Status
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Recruiting
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Nation
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England, Wales
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Location
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Birmingham, Brighton, Bristol, Cambridge, Cardiff, Exeter, Gloucester, Harrow, Liverpool, London, Manchester, Norwich, Oxford, Shropshire , Somerset , South Shields, Southampton
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