Trials / Completed
CompletedNCT01387594
Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs
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)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.
Conditions
- Crohn's Disease
- Ileitis
- Ileo-colonic and Colonic Crohn's Disease
- Granulomatous Colitis
- Regional Enteritis
- Ulcerative Colitis
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | lumbar puncture | 2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses. |
| DRUG | lumbar puncture | 1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses. |
Timeline
- Start date
- 2012-05-03
- Primary completion
- 2014-03-31
- Completion
- 2015-11-26
- First posted
- 2011-07-04
- Last updated
- 2021-06-03
- Results posted
- 2017-04-26
Locations
9 sites across 5 countries: Austria, Belgium, France, Germany, Netherlands
Source: ClinicalTrials.gov record NCT01387594. Inclusion in this directory is not an endorsement.