B0151005 Open-Label Extension Study (ANDANTE II)
|ClinicalTrials.gov Identifier: NCT01345318|
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Biological: PF-04236921||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||191 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
|Experimental: Open-label Treatment||
Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.
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.
- Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs [ Time Frame: Baseline up to Week 48 ]An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
- Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) [ Time Frame: At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76. ]Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345318
|Study Director:||Pfizer CT.gov Call Center||Pfizer|