A Study To Monitor Long-Term Treatment With PF-00547659
NCT01298492 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 268
Last updated 2021-06-03
Summary
This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.
Conditions
Interventions
- DRUG
-
PF-00547659
75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.
Sponsors & Collaborators
-
Shire
lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-07-01
- Primary Completion
- 2016-07-27
- Completion
- 2016-07-27
Countries
- United States
- Austria
- Belgium
- Canada
- France
- Germany
- Japan
- Netherlands
- Norway
- Poland
- Serbia
- Slovakia
- South Africa
- South Korea
- Spain
Study Locations
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