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Health Condition(s) or Problem
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Crohn's Disease; Inflammatory Bowel Disease; IBD; Colitis
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Lay Summary
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This study (UNITI-2) will compare the effects (both positive and negative) of an initial
treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely
active Crohn's disease.
(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 Disease Activity Index
(CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
- Has failed conventional therapy as demonstrated by having received corticosteroids
and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR
Have a history of failure to respond to or tolerate an adequate course of
corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate
therapeutic doses OR Is corticosteroid dependent or has had a history of
corticosteroid dependency AND Has not previously demonstrated failure of or
intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or
certolizumab pegol) per study criteria
- 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 Disease Activity Index
(CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
- Has failed conventional therapy as demonstrated by having received corticosteroids
and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR
Have a history of failure to respond to or tolerate an adequate course of
corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate
therapeutic doses OR Is corticosteroid dependent or has had a history of
corticosteroid dependency AND Has not previously demonstrated failure of or
intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or
certolizumab pegol) per study criteria
- 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 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; Drug; Group 2 ustekinumab 130 mg; Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.; 002
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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; Clinical improvement/response; Study visits through Week 8; No
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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/CR018418
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Birmingham, Brighton, Bristol, Cambridge, Gloucester, Harrow, Liverpool, London, Manchester, Norwich, Oxford, Shrewsbury, South Shields, Southampton
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