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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01345318




Registration number
NCT01345318
Ethics application status
Date submitted
28/04/2011
Date registered
2/05/2011
Date last updated
12/01/2024

Titles & IDs
Public title
B0151005 Open-Label Extension Study
Scientific title
A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)
Secondary ID [1] 0 0
2011-000722-30
Secondary ID [2] 0 0
B0151005
Universal Trial Number (UTN)
Trial acronym
ANDANTE II
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
Other interventions - PF-04236921
Other interventions - PF-04236921

Experimental: Open-label Treatment -


Other interventions: PF-04236921
Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.

Other interventions: PF-04236921
Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Timepoint [1] 0 0
Baseline up to Week 48
Primary outcome [2] 0 0
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Timepoint [2] 0 0
At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.

Eligibility
Key inclusion criteria
- Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12
week) induction period.

- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

- Women of childbearing potential, who have sexual intercourse with a non surgically
sterilized male partner, must agree and commit to the use highly effective methods of
birth control from signing of the ICD through 26 weeks after the Final Study
Evaluation or for 62 weeks from the last dose of investigational product for any
subject who terminates early from this study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced
serious event(s) related to the investigational product, an unstable medical
condition, or any other reason, in the opinion of the investigator, would preclude
entry or inclusion in this study.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate entry into this study.

- Received any prohibited treatment during study B0151003 that, in the opinion of the
investigator, compromised the safety or efficacy of this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [4] 0 0
Eastern Health, Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Michigan
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New York
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Roeselare
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Brazil
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PR
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Brazil
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RJ
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Brazil
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SP
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Praha 10
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Czechia
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Praha 4
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Czechia
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Usti nad Labem
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Denmark
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Aarhus C
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Denmark
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Herlev
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Denmark
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Hilleroed
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Hvidovre
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Koebenhavn NV
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Denmark
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Koebenhavn
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Denmark
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Koege
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France
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Cedex 12
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France
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Lille Cedex
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Germany
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Niedersachsen
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Minden
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Hungary
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Szekszard
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Ireland
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Dublin
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Ireland
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Galway
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Israel
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Jerusalem
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Italy
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Milano
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Italy
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Padova
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Italy
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Roma
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Italy
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Rome
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New Zealand
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Auckland
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New Zealand
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Hamilton
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Switzerland
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Zuerich
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-center Phase 2, open label, safety extension study in subjects with moderate
to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will
have completed the 12-week induction period of study B0151003 and will be enrolled as either
responders or non responders.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01345318
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01345318