Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:12/6/2018
Start Date:December 20, 2016
End Date:December 12, 2017

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A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate

This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in
seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate
(up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF
biologic).


Inclusion Criteria

- Subjects between the ages of 18 and 75 years, inclusive

- Must have moderate-to-severe, active Rheumatoid Arthritis

- Must have had an inadequate response to Methotrexate

- Subjects may have received one approved TNF inhibiting biologic agent that was
inadequately effective and/or not tolerated

Exclusion Criteria

- Subjects with any acute or chronic infections or infection history

- Have acute or active chronic dermatological disorders prior to study start

- Any major illness/condition(s) or evidence of an unstable clinical condition that in
the judgment of the investigator would make the subject inappropriate for entry into
this study

- Known immunodeficiency disorder or a first degree relative with hereditary
immunodeficiency

- Any live (attenuated) vaccines or current routine household contact with anyone who
has received live (attenuated) vaccine
We found this trial at
5
sites
Mesquite, Texas 75150
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Mesquite, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Northridge, California 91324
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Northridge, CA
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Plovdiv,
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6400 Clayton Road
Saint Louis, Missouri 63117
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Saint Louis, MO
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