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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01287897




Registration number
NCT01287897
Ethics application status
Date submitted
31/01/2011
Date registered
2/02/2011
Date last updated
21/01/2016

Titles & IDs
Public title
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
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)
Secondary ID [1] 0 0
2010-023034-23
Secondary ID [2] 0 0
B0151003
Universal Trial Number (UTN)
Trial acronym
ANDANTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-04236921 SC injection
Treatment: Drugs - PF-04236921 SC injection
Treatment: Drugs - PF-04236921 SC injection

Placebo comparator: Placebo- SC injection -

Experimental: Drug Dose level 1 - SC injection -

Experimental: Drug Dose level 2 - SC injection -


Treatment: Drugs: PF-04236921 SC injection
Placebo delivered SC, 2 doses separated by 4 weeks

Treatment: Drugs: PF-04236921 SC injection
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks

Treatment: Drugs: PF-04236921 SC injection
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and Week 8
Primary outcome [2] 0 0
The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [2] 0 0
Baseline and Week 8
Primary outcome [3] 0 0
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [3] 0 0
Baseline and Week 12
Primary outcome [4] 0 0
The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [1] 0 0
Baseline and Weeks 2, 4, 6, and 10
Secondary outcome [2] 0 0
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [2] 0 0
Baseline and Weeks 2, 4, 6, and 10
Secondary outcome [3] 0 0
The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [3] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [4] 0 0
The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [4] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [5] 0 0
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [5] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [6] 0 0
The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [6] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [7] 0 0
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
Timepoint [7] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [8] 0 0
Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
Timepoint [8] 0 0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [9] 0 0
Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
Timepoint [9] 0 0
At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
Secondary outcome [10] 0 0
Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
Timepoint [10] 0 0
At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
Secondary outcome [11] 0 0
Serum PF-04236921 Concentration Over Time
Timepoint [11] 0 0
Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40
Secondary outcome [12] 0 0
Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)
Timepoint [12] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Nepean Public Hospital - Kingswood
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston, Brisbane
Recruitment hospital [4] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [5] 0 0
Eastern Health, Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
4029 - Herston, Brisbane
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
VIC 3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
Country [3] 0 0
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Indiana
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Kentucky
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Maryland
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01287897