Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs (TOSCA)
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|ClinicalTrials.gov Identifier: NCT01387594|
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : April 26, 2017
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Ileitis Ileo-colonic and Colonic Crohn's Disease Granulomatous Colitis Regional Enteritis Ulcerative Colitis||Procedure: lumbar puncture Drug: lumbar puncture||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||November 2015|
Experimental: Cohort 1
Interventions prior to treatment. Control arm
Procedure: lumbar puncture
2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses.
Experimental: Cohort 2
Interventions prior to and after 3 monthly injections
Drug: lumbar puncture
1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.
- Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) [ Time Frame: Baseline ]The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.
- Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3 [ Time Frame: Baseline, Month 3 ]The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.
- Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period [ Time Frame: Baseline up to Week 12 ]An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent for this measure are events between first dose of study drug and up to 85 days (Week 12) after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and non-serious AEs.
- Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 [ Time Frame: Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal ]Serum samples were analysed for presence of ADAs to PF-00547659. Participants who showed positive results for PF-00547659 were reported.
- Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity [ Time Frame: Baseline till End of Study/Early Withdrawal, up to Week 12 ]Injection site reaction AEs include: injection site irritation, injection site pain, injection site rash, contusion, and erythema.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387594
|AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und|
|Wien, Austria, 1090|
|Brussels, Belgium, B-1000|
|Leuven, Belgium, B-3000|
|Lille Cedex, France, 59037|
|Hopital Huriez, CHRU de Lille|
|Lille Cedex, France, 59037|
|Hopital Saint-Louis - CIC|
|Paris, France, 75010|
|Paris, France, 75010|
|Charité, Universitaetsmedizin Berlin, Campus Virchow Klinikum,|
|Berlin, Germany, 13353|
|Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology|
|Amsterdam, Netherlands, 1105 AZ|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|