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

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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

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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 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; Baseline and Week 8; The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg; Baseline and Week 8; The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; Baseline and Week 12; The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg; Baseline and Week 12
Secondary Outcome Measures
    The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; Baseline and Weeks 2, 4, 6, and 10; The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg; Baseline and Weeks 2, 4, 6, and 10; The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; Baseline and Weeks 2, 4, 6, 8, 10, and 12; The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg; Baseline and Weeks 2, 4, 6, 8, 10, and 12; The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; Baseline and Weeks 2, 4, 6, 8, 10, and 12; The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg; Baseline and Weeks 2, 4, 6, 8, 10, and 12; Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; Baseline and Weeks 2, 4, 6, 8, 10, and 12; Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg; Baseline and Weeks 2, 4, 6, 8, 10, and 12; Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs); At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40; Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs); At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40; Serum PF-04236921 Concentration Over Time; Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40; Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs); Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results 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 shortly if the information you need is not here or, if named, 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 shortly if the information you need is not here or, if named, 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
Hull Royal Infirmary
Hull
HU3 2JZ
Glasgow Royal Infirmary
Glasgow
G40SS
Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton
WV69AT
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 shortly if the information you need is not here or, if named, 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

14 Dec 2015