A Study To Monitor Long-Term Treatment With PF-00547659 (OPERA II)
|ClinicalTrials.gov Identifier: NCT01298492|
Recruitment Status : Completed
First Posted : February 17, 2011
Results First Posted : August 31, 2017
Last Update Posted : August 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: PF-00547659||Phase 2|
The rationale for conducting this open-label extension (OLE) study is primarily to evaluate long term safety of PF 00547659. This protocol also provides the opportunity for continued treatment for subjects responding to treatment from the feeder study. It also provides an opportunity for initial treatment for subjects randomized to placebo in the feeder study. This is a multi center Phase 2, open label, safety extension study for feeder studies which evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 with a clinical response, as defined by that protocol, will also be eligible for this study and treated as "responders". All subjects entering this study must have discontinued immunosuppressant therapy.
Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4 weeks through Week 72. After the active treatment period, the subjects will enter a 24 month follow up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will continue the every 6 month telephone contacts until Week 168.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||268 participants|
|Official Title:||A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II|
|Actual Study Start Date :||July 1, 2011|
|Actual Primary Completion Date :||July 27, 2016|
|Actual Study Completion Date :||July 27, 2016|
Experimental: Open-Label Treatment
Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008
75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.
- Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) [ Time Frame: From start of study treatment up to Week 72 (Treatment Period) ]AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.
- Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies [ Time Frame: Baseline up to Week 96 ]Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points.
- Serum Trough Concentrations of PF-00547659 Versus Time [ Time Frame: Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96 ]Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298492
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|