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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 has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 30, 2011
Last updated: January 21, 2016
Last verified: January 2016
Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.

Condition Intervention Phase
Crohn's Disease
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: Parallel 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 ]

Enrollment: 49
Study Start Date: May 2012
Study Completion Date: November 2015
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01387594

AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und
Wien, Austria, 1090
Hopital Erasme
Brussels, Belgium, B-1000
UZ Gasthuisberg
Leuven, Belgium, B-3000
Hopital Cardiologique
Lille Cedex, France, 59037
Hopital Huriez, CHRU de Lille
Lille Cedex, France, 59037
Hopital Saint-Louis - CIC
Paris, France, 75010
Hopital Saint-Louis
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
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01387594     History of Changes
Other Study ID Numbers: A7281008  2011-001443-74 
Study First Received: June 30, 2011
Last Updated: January 21, 2016
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:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Ileal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016