At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 49 enrolled
Drug / intervention
lumbar puncture +1 moredrug
Likely dose
lumbar puncture 225mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)
In Brief
A Phase 1 clinical trial evaluating lumbar puncture for Crohn's Disease and 5 related conditions. Completed, enrolled 49 participants across 9 sites in 5 countries.
Detailed Summary
Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, Ileitis, Ileo-colonic and Colonic Crohn's Disease, Granulomatous Colitis, Regional Enteritis, Ulcerative Colitis
CountriesAustria, Belgium, France, Germany, Netherlands
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartMay 2012
Primary CompletionMar 2014
Study CompletionNov 2015
TodayJul 2026
First PostedJul 4, 2011
Enrollment StartMay 3, 2012
Primary CompletionMar 31, 2014
Study CompletionNov 26, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.0 years ago
Interventions
lumbar punctureprocedure
2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses.
lumbar puncturedrug
1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.