A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis



Status:Active, not recruiting
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:November 22, 2017
End Date:November 2020

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A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis

This is a study to assess the long-term safety and tolerability of bimekizumab in subjects
with psoriatic arthritis


Inclusion Criteria:

- In the opinion of the Investigator, the subject is expected to benefit from
participation in an Open Label Extension (OLE) study

- Subject completed PA0008 without meeting any withdrawal criteria

- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
potential, must be willing to use a highly effective method of contraception

- Male subjects with a partner of childbearing potential must be willing to use a condom
when sexually active

Exclusion Criteria:

- Female subjects who plan to become pregnant during the study or within 20 weeks
following the last dose of IMP. Male subjects who are planning a partner pregnancy
during the study or within 20 weeks following the last dose

- Subjects with any current sign or symptom that may indicate a medically significant
active infection (except for the common cold) or has had an infection requiring
systemic antibiotics within 2 weeks of study entry

- Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing
Serious Adverse Event, or a history of serious infections (including hospitalizations)
in the lead-in study, the Medical Monitor must be consulted prior to the subject's
entry into PA0009
We found this trial at
12
sites
Lansing, Michigan 48910
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Lansing, MI
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Brno,
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Brno,
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Charleston, South Carolina 29406
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Charleston, SC
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Dallas, Texas 75231
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Hagerstown, Maryland 21502
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Hagerstown, MD
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Jackson, Tennessee 38305
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Jackson, TN
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Johnston, Rhode Island 02919
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Johnston, RI
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Lexington, Kentucky 40504
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Lexington, KY
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Mesquite, Texas 75150
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Mesquite, TX
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Portland, Oregon 97239
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Portland, OR
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Rochester, New York 14642
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from
Rochester, NY
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