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Health Condition(s) or Problem
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Crohn's Disease
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Lay Summary
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This is a proof of concept study to determine the efficacy and safety of a monoclonal
antibody with three doses versus placebo. Subjects will be randomized to a treatment and the
dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate
to severe refractory Crohn's Disease.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Subjects must have failed or are intolerant to anti TNFs
- hsCRP greater or equal to 5.0 mg/L
- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
within 8 weeks of study entry (screening) and able to retrospectively complete the
SES-CD or colonoscopy performed during screening
Exclusion Criteria:
- Pregnant or breastfeeding women
- Crohn's Disease with active fistulae or abscess
- History of diverticulitis or symptomatic diverticulosis
- Abnormality in hematology or chemistry profiles at screening
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Who cannot enter the trial
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Inclusion Criteria:
- Subjects must have failed or are intolerant to anti TNFs
- hsCRP greater or equal to 5.0 mg/L
- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
within 8 weeks of study entry (screening) and able to retrospectively complete the
SES-CD or colonoscopy performed during screening
Exclusion Criteria:
- Pregnant or breastfeeding women
- Crohn's Disease with active fistulae or abscess
- History of diverticulitis or symptomatic diverticulosis
- Abnormality in hematology or chemistry profiles at screening
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What will happen
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Drug; PF-04236921 SC injection; Placebo delivered SC, 2 doses separated by 4 weeks; Placebo- SC injection; Drug; PF-04236921 SC injection; Drug dose level 1 delivered SC, 2 doses separated by 4 weeks; Drug Dose level 1 - SC injection; Drug; PF-04236921 SC injection; Drug dose level 2 delivered SC, 2 doses separated by 4 weeks; Drug Dose level 2 - SC injection; Drug; PF-04236921 SC injection; Drug dose level 3 delivered SC, 2 doses separated by 4 weeks; Drug Dose level 3 - SC injection
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Primary aim
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The Crohn's Disease Activity Index (CDAI) 70 response rate at Week 8 or Week 12
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Secondary Aim
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Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses; Weeks 2 through 12; No; Mean change from baseline for CDAI score; Weeks 2 through 12; No; Percent of subjects that develop anti drug antibodies (ADAs) and neutralizing antibodies (NAbs), if observed; baseline, and Weeks 4, 8, 12, 16, 24, 32 and 40; Yes; Serum concentrations of PF 04236921; Baseline, Weeks 2, 4, 6, 8, 10 and Week 12 and monthly through Week 40; 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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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0151003&StudyName=A%20Study%20To%20Assess%20The%20Efficacy%20And%20Safety%20Of%20PF-04236921%20In%20Subjects%20With%20Crohn%27s%20Disease%20Who%20Failed%20Anti-TNF%20Therapy
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Recruitment Status
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Recruiting
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Nation
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England, Scotland
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Location
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Cambridge, Hull, Glasgow, London, Salford, Newcastle upon Tyne, Southampton, Wolverhampton
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