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Health Condition(s) or Problem
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Crohn's Disease; Colitis; IBD; Inflammatory Bowel Disease
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Lay Summary
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The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance
regimens of ustekinumab administered subcutaneously to patients with moderately to severely
active Crohn's disease who responded to treatment with intravenous ustekinumab in studies
CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Patients who received study agent at the start of study CNTO1275CRD3001 or
CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:
- Patients who underwent a Crohn's disease-related surgery since the start of induction
study CNTO1275CRD3001 or CNTO1275CRD3002
- Patients who started a protocol prohibited medication since the start of studies
CNTO1275CRD3001 and CNTO1275CRD3002
- Patients with protocol-specified changes to their concomitant medications due to
Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001
and CNTO1275CRD3002
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Who cannot enter the trial
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Inclusion Criteria:
- Patients who received study agent at the start of study CNTO1275CRD3001 or
CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:
- Patients who underwent a Crohn's disease-related surgery since the start of induction
study CNTO1275CRD3001 or CNTO1275CRD3002
- Patients who started a protocol prohibited medication since the start of studies
CNTO1275CRD3001 and CNTO1275CRD3002
- Patients with protocol-specified changes to their concomitant medications due to
Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001
and CNTO1275CRD3002
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What will happen
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Drug; Placebo; Responders to ustekinumab:
Form=solution for injection, route=Subcutaneous use. One SC injection q4w; 001; Drug; Ustekinumab; Responders to ustekinumab:
Form=solution for injection, route=Subcutaneous use. One SC injection q12w; 002; Drug; Ustekinumab; Responders to ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection q8w; 003; Drug; Ustekinumab; Nonresponders to IV induction ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection at Week 0; 004; Drug; Ustekinumab; if then respond, one SC injection q8w; 005
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Primary aim
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Clinical remission
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Secondary Aim
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Remission in patient subgroups such as those in remission at Week 0 or those who previously failed TNF-antagonists (ie, patients entering from study CNTO1275CRD3001); at Week 44; No; Clinical response; at Week 44; No; Corticosteroid-free remission; at Week 44; 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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Sorry, not currently available
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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 , South Shields, Southampton
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