A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With C... | Completed
A Study To Assess The Efficacy And ... | Completed
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
ANDANTE
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Crohn's Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01287897
Primary Trial ID Number
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : PF-04236921 SC injection, Drug : PF-04236921 SC injection, Drug : PF-04236921 SC injection

Study Arm Groups : Placebo- SC injection, Drug Dose level 1 - SC injection, Drug Dose level 2 - SC injection

Intervention Type
See Interventions above
Primary Outcome Measures
  • The Crohn's Disease Activity Index (CDAI) 70 response rate at Week 8 or Week 12; Baseline, Weeks 2, 4, 6, 8, 10 and 12
Secondary Outcome Measures
  • Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses; Weeks 2 through 12; Mean change from baseline for CDAI score; Weeks 2 through 12; Percent of subjects that develop anti drug antibodies (ADAs) and neutralizing antibodies (NAbs), if observed; baseline, and Weeks 4, 8, 12, 16, 24, 32 and 40; Serum concentrations of PF 04236921; Baseline, Weeks 2, 4, 6, 8, 10 and Week 12 and monthly through Week 40
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Gender
Both
Age Range
18 Years - 75 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Subjects must have failed or are intolerant to anti TNFs
  • - hsCRP greater or equal to 5.0 mg/L
  • - Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
  • within 8 weeks of study entry (screening) and able to retrospectively complete the
  • SES-CD or colonoscopy performed during screening
  • Exclusion Criteria:
  • - Pregnant or breastfeeding women
  • - Crohn's Disease with active fistulae or abscess
  • - History of diverticulitis or symptomatic diverticulosis
  • - Abnormality in hematology or chemistry profiles at screening
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Trial Location(s)
GSK Investigational Site
London
E1 1BB
GSK Investigational Site
London
NW3 2QG
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne
England
NE1 4LP
GSK Investigational Site
Cambridge
CB2 0QQ
Novartis Investigative Site
Wolverhampton
WV10 0QP
Glasgow Renal and Transplant Unit
Glasgow
G11 6NT
Hull Royal Infirmary
Hull
HU3 2JZ
Glasgow Clinical Research Facility
Glasgow
G33 2ER
Glasgow Royal Infirmary
Glasgow
G40SS
Pharmacy Department
Glasgow
G3 0SF
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, New Zealand, Romania, Switzerland, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information, or it may still be awaited from the organisation running the trial. Please look again in a few days if the information you need is not here, or contact the researcher named above.
Scientific Title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
B0151003
Sponsor(s)
Pfizer
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Sep 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

31 Jan 2011

Last Updated

19 Apr 2015

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