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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01387594
First received: June 30, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.


Condition Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 The Cerebrospinal Fluid (Csf) Lymphocytes In Volunteers With Crohn's Disease Or Ulcer Ulcerative Colitis Who Are Anti-tnf Inadequate Responders (Tosca)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent change from baseline (pre treatment) in absolute lymphocyte count in CSF in subjects with CD or UC after receiving 3 monthly doses of PF-00547659 [ Time Frame: Week 9-11 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of on treatment adverse events, withdrawal due to adverse events, and serious adverse events (SAEs) will be reported [ Time Frame: Week 36 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects developing anti-drug antibodies (ADA) to PF-00547659 [ Time Frame: Week 36 ] [ Designated as safety issue: Yes ]
  • Frequency of injection site reactions and other hypersensitivity reactions [ Time Frame: Week 36 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: January 2016
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males and females >=18 and =<75 years
  • For CD subjects: hsCRP > 5 mg/L and Harvey-Bradshaw Index > 8 OR when HBI cannot be determined (ie if stoma is present) or hsCRP < 5mg/L then: active lesions on colonoscopy or flexible sigmoidoscopy or active Crohn's disease on CT or MR enterography
  • For UC subjects: diagnosis of UC > 3 months; must have endoscopy to confirm active disease during screening; total mayo score of 6 to 12 points and moderate to severe disease on endoscopy

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • TB or active enteric infections
  • Entero vesicular fistulae
  • Prior use of natalizumab or vedolizumab
  • Right or left heart failure including symptomatic diastolic dysfunction or unexplained elevation of troponin I (>0.05 ng/mL)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387594

Locations
Austria
AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und
Wien, Austria, 1090
Belgium
Hopital Erasme
Brussels, Belgium, B-1070
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Gastroenterology
Leuven, Belgium, 3000
France
Hopital Cardiologique - Centre d'Investigation Clinique
Lille, France, 59037
Hopital Huriez, CHRU de Lille
Lille Cedex, France, 59037
CIC
Paris, France, 75010
Hopital Saint-Louis
Paris, France, 75010
Hopital Saint-Louis, Service Pharmacie
Paris, France, 75010
Germany
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
Berlin, Germany, 13353
Netherlands
Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01387594     History of Changes
Other Study ID Numbers: A7281008, 2011-001443-74
Study First Received: June 30, 2011
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Crohn's disease lumbar puncture anti-MAdCAM monoclonal antibody PF-00547659 Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 28, 2014