Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease (OPERA)

May 11, 2021 updated by: Shire

A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
265

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • Belgium
      • Leuven, Belgium, B-3000
        • UZ Gasthuisberg
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique
      • Mouscron, Belgium, 7700
        • Centre Hospitalier De Mouscron
  • Bulgaria
      • Sofia, Bulgaria, 1000
        • 4-MHAT
      • Sofia, Bulgaria, 1979
        • MBAL Sofiamed OOD,Otdelenie po gastroenterologia
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health - Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health - Vancouver Hospital
    • Ontario
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates Inc.
  • France
      • Amiens Cedex 01, France, 80054
        • CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie
      • Bordeaux cedex, France, 33075
        • Hôpital Saint-André
      • Clichy Cedex, France, 92110
        • Hopital Beaujon- Essais cliniques
      • NICE Cedex 3, France, 06202
        • Hopital de l'Archet 2 - CHU de Nice
      • Paris, France, 75014
        • Hopital Cochin-Essais Cliniques
      • Rouen Cedex 1, France, 76031
        • Hôpital Charles Nicolle
      • St Priest En Jarez, France, 42270
        • Hopital Nord
      • Toulouse cedex 09, France, 31059
        • Hôpital Rangueil
  • Germany
      • Berlin, Germany, 10117
        • Charite - Campus Berlin Mitte Medizinische Klinik
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Doelau gGmbH
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein
      • Luebeck, Germany, 23538
        • Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Regensburg, Germany, 93042
        • Universitaetsklinikum Regensburg
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus
      • Ulm, Germany, 89081
        • Universitaetklinikum Ulm
  • Japan
      • Aichi, Japan, 480-1195
        • Aichi Medical University Hospital
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki National Hospital
    • Gunma
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8471
        • Jikei University Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio university hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 705-717
        • Yeungnam University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 110-746
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University College of Medicine, Severance Hospital
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
    • GR
      • Groningen, GR, Netherlands, 9713GZ
        • University Medical Center Groningen (UMCG)
    • NH
      • Amsterdam, NH, Netherlands, 1105 AZ
        • Academic Medical Center
  • Norway
      • Gjettum, Norway, 1346
        • Asker and Baerum Hospital
      • Oslo, Norway, 0424
        • Oslo Universitetssykehus
      • Oslo, Norway, 0440
        • Lovisenberg diakonale sykehus
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej
      • Lodz, Poland, 90-302
        • Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie
      • Wroclaw, Poland, 53-114
        • LexMedica
  • Serbia
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11080
        • Clinical Hospital Centre Bezanijska Kosa
      • Nis, Serbia, 18000
        • Clinical Center Nis Clinic for Gastroenterology and Hepatology
      • Zemun, Serbia, 11080
        • Clinical Hospital Center Zemun
  • Slovakia
      • Bratislava, Slovakia, 831 04
        • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
      • Bratislava, Slovakia, 851 01
        • Medak s.r.o.
      • Nitra, Slovakia, 949 01
        • Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.
      • Nove Mesto Nad Vahom, Slovakia, 915 01
        • Synergy group, a.s.
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research
    • Kwa-zulu - Natal
      • Durban, Kwa-zulu - Natal, South Africa, 4091
        • Parklands Medical Centre
    • Western CAPE
      • Cape Town, Western CAPE, South Africa, 7708
        • Kingsbury Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08907
        • Hospital Universitari Bellvitge
      • Madrid, Spain, 28006
        • Hospital Universitario De La Princesa
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Sabadell, Spain, 08208
        • Corporació Sanitària Parc Taulí de Sabadell
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro Majadahonda
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Clopton Clinic
      • Jonesboro, Arkansas, United States, 72401
        • Gastroenterology Specialists of Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Diagnostic Clinic, P.A.
    • California
      • La Jolla, California, United States, 92037
        • UCSD Medical Center-Thornton Hospital
      • Orange, California, United States, 92868
        • Community Clinical Trials
      • Orange, California, United States, 92868
        • Gastro Diagnostics
      • Redlands, California, United States, 92374
        • Inland Gastroenterology Medical Associates, Inc.
      • Whittier, California, United States, 90603
        • BioMark Research Inc.
    • Colorado
      • Lafayette, Colorado, United States, 80026
        • Clinical Research of the Rockies
      • Thornton, Colorado, United States, 80229
        • Rocky Mountain Gastroenterology Associates
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Foundation
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital at the University of Florida
      • Gainesville, Florida, United States, 32608
        • Shands Endoscopy Center
      • Gainesville, Florida, United States, 32610
        • Shands Medical Plaza
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Largo, Florida, United States, 33777
        • Florida Center for Gastroenterology
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinic
      • Miami, Florida, United States, FL 33136
        • University of Miami
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, United States, 32806
        • Cirtus Ambulartory Surgery Center
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center
      • Clive, Iowa, United States, 50325
        • Heartland Medical Research (Administrative Only)
      • Clive, Iowa, United States, 50325
        • Iowa Endoscopy Center (Colonoscopy Only)
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Worcester
    • Michigan
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
      • Troy, Michigan, United States, 48098
        • Surgical Centers of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minneapolis Heart Institute, West Health Campus
      • Minneapolis, Minnesota, United States, 55407
        • Noran Neurology Clinic
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, P.A.
      • Plymouth, Minnesota, United States, 55446
        • Consulting Radiology (Xray testing only)
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Surgery Center of Columbia
      • Mexico, Missouri, United States, 65265
        • Audrain Medical Center
      • Mexico, Missouri, United States, 65265
        • Center for Digestive and Liver Diseases, Inc.
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Center for Advanced Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital - Investigational Drug Services
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Brooklyn, New York, United States, 11206
        • Life Medi-research and Management
      • Flushing, New York, United States, 11355
        • New York Hospital Queens
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
      • Great Neck, New York, United States, 11021
        • Nassau Gastroenterology Associates Office Based Surgery
      • Great Neck, New York, United States, 11021
        • Nassau Gastroenterology Associates, P.C.
      • Great Neck, New York, United States, 11021
        • North Shore Primary Care, P.C.
      • New York, New York, United States, 10003
        • Beth Israel Medical Center - Phillip Ambulatory Care Center
      • New York, New York, United States, 10010
        • East side Endoscopy, LLC (for colonscopy testing only)
      • New York, New York, United States, 10075
        • Lenox Hill Endoscopy Center
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • CTRC Hospital - UNC Memorial Hospital
      • Chapel Hill, North Carolina, United States, 27514
        • North Carolina Memorial Hospital Endoscopy Center
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals Department of Pharmacy
      • Chapel Hill, North Carolina, United States, 27517
        • UNC Hospitals Endoscopy
      • Hillsborough, North Carolina, United States, 27278
        • Hillsborough Campus
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • The Offices of Dr. Vincent Armenio, M.D.
      • East Providence, Rhode Island, United States, 02915
        • Pharma Resource
      • Providence, Rhode Island, United States, 02905
        • Bayside Endoscopy Center
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • Pasadena, Texas, United States, 77505
        • Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah HSC
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
      • Charlottesville, Virginia, United States, 22902
        • Charlottesville Gastroenterology Associates
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists
      • Wauwatosa, Wisconsin, United States, 53226
        • GI Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
  • hsCRP greater than 3mg/L
  • Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria:

  • Pregnant or breast feeding
  • Short bowel syndrome due to multiple small bowel resections
  • Presence of a stoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo-SC Injection
Placebo delivered SC, 3 doses separated by 4 weeks.
Drug: PF-00547659 SC injection
Placebo delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 1- SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.
Drug: PF-00547659 SC injection
Placebo delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 2-SC injection
Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.
Drug: PF-00547659 SC injection
Placebo delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 3- SC injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.
Drug: PF-00547659 SC injection
Placebo delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Drug: PF-00547659 SC injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate
Time Frame: Week 8 and week 12
Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.
Week 8 and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo
Time Frame: Week 0-12
Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.
Week 0-12
Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo
Time Frame: Week 0-12
Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.
Week 0-12
Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission
Time Frame: Weeks 8 and week 12
Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).
Weeks 8 and week 12
Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time
Time Frame: Week 2, 4, 6, 8, 10 and 12
Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.
Week 2, 4, 6, 8, 10 and 12
Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer
Time Frame: Week 2, 4, 6, 8, 10 and 12
Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.
Week 2, 4, 6, 8, 10 and 12
Immunogenicity Assessment of Anti-drug Antibodies (ADAs)
Time Frame: Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36
Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659
Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)
Time Frame: Day 1, 14, and 28
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)
Day 1, 14, and 28
The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)
Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)
Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)
Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)
Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252
The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.
Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A7281006
  • 2010-023437-30 (EudraCT Number)
  • OPERA (Alias Study Number)

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