A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis.
1 other identifier
interventional
80
7 countries
18
Brief Summary
study to investigate the safety and efficacy properties of PF-00547659 in patients with active ulcerative colitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2005
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedJune 26, 2009
June 1, 2009
2.6 years
June 22, 2009
June 25, 2009
Conditions
Outcome Measures
Primary Outcomes (3)
Safety and toleration
up to 12 weeks
Endoscopic score changes as calculated using section 3 of the Mayo Score
up to 12 weeks
Disease activity score changes as calculated using the Mayo Score
up to 12 weeks
Secondary Outcomes (3)
Plasma concentrations of PF-00547659
up to 12 weeks
Fecal concentrations of calprotectin
up to 12 weeks
Plasma concentrations of CRP
up to 12 weeks
Study Arms (12)
0.03 mg/kg or placebo iv
OTHER0.1 mg/kg or placebo iv
OTHER0.3 mg/kg or placebo iv
OTHER1.0 mg/kg or placebo iv
EXPERIMENTAL3.0 mg/kg or placebo sc
OTHER10 mg/kg or placebo iv
OTHER0.3 mg/kg or placebo sc
OTHER0.1 mg/kg or placebo iv (multiple dose)
OTHER0.3 mg/kg or placebo iv (multiple dose)
OTHER3.0 mg/kg or placebo iv
OTHER0.1 mg/kg or placebo sc
OTHER0.3 mg/kg or placebo sc (multiple dose)
OTHERInterventions
Eligibility Criteria
You may qualify if:
- A positive histological diagnosis of UC ≥3 months prior to entry into the study. If a histological diagnosis is not available but all signs and symptoms suggest UC, the subject's eligibility should be discussed with Pfizer.
- Active UC as defined by a score of ≥6 on the Mayo score.
- An endoscopic (by flexible sigmoidoscopy) sub-score of ≥2 on the Mayo score determined within 7 days of first dosing.
You may not qualify if:
- Subjects with UC, which is confined to a proctitis on a flexible sigmoidoscopy.
- Subjects who have had surgery as a treatment for UC or are likely to require surgery within the duration of the study.
- Subjects displaying clinical signs of ischemic colitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (18)
Pfizer Investigational Site
Brussels, 1200, Belgium
Pfizer Investigational Site
Brussels, B-1070, Belgium
Pfizer Investigational Site
Leuven, 3000, Belgium
Pfizer Investigational Site
Brno, 625 00, Czechia
Pfizer Investigational Site
Prague, 120 00, Czechia
Pfizer Investigational Site
Prague, 128 01, Czechia
Pfizer Investigational Site
Aarhus C, 8000, Denmark
Pfizer Investigational Site
Berlin, 10117, Germany
Pfizer Investigational Site
Kiel, 24105, Germany
Pfizer Investigational Site
Münster, 48129, Germany
Pfizer Investigational Site
Regensburg, 93042, Germany
Pfizer Investigational Site
Oslo, 0027, Norway
Pfizer Investigational Site
Nitra, 950 01, Slovakia
Pfizer Investigational Site
Barcelona, BARCELONA, 08025, Spain
Pfizer Investigational Site
Barcelona, BARCELONA, 08035, Spain
Pfizer Investigational Site
L'hospitalet DEL Llobregat, BARCELONA, 08907, Spain
Pfizer Investigational Site
Madrid, Madrid, 28040, Spain
Pfizer Investigational Site
Majadahonda, Madrid, 28222, Spain
Related Publications (1)
Vermeire S, Ghosh S, Panes J, Dahlerup JF, Luegering A, Sirotiakova J, Strauch U, Burgess G, Spanton J, Martin SW, Niezychowski W. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut. 2011 Aug;60(8):1068-75. doi: 10.1136/gut.2010.226548. Epub 2011 Feb 11.
PMID: 21317177DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 22, 2009
First Posted
June 26, 2009
Study Start
September 1, 2005
Primary Completion
April 1, 2008
Study Completion
October 1, 2008
Last Updated
June 26, 2009
Record last verified: 2009-06