Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
NCT ID: NCT02969044
Last Updated: 2018-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2016-12-20
2017-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF-06651600
Study Drug
PF-06651600
200mg pill every day (QD) for 8 weeks
Placebo
Placebo
Placebo
Interventions
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Placebo
PF-06651600
200mg pill every day (QD) for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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California Medical Research Associates Inc.
Northridge, California, United States
Clayton Medical Associates, PC
St Louis, Missouri, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
MHAT "Trimontsium" Department of Internal Diseases
Plovdiv, , Bulgaria
UMHAT Kaspela, Clinic of Rheumatology
Plovdiv, , Bulgaria
Medical Centre "Pirogov"
Sofia, , Bulgaria
Medical Center Equita
Varna, , Bulgaria
Medical Center "Sveti Ivan Rilski"
Vidin, , Bulgaria
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
LTD "Unimed Ajara" Batumi Referral Hospital
Batumi, , Georgia
LTD Israeli-Georgian Medical Research Clinic ,,Helsicore"
Tbilisi, , Georgia
Ltd Institute of Clinical Cardiology
Tbilisi, , Georgia
LTD Unimedi Kakheti
Tbilisi, , Georgia
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Rheumatologische Schwerpunktpraxis
Berlin, , Germany
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly
Nyíregyháza, , Hungary
NZOZ Centrum Medyczne Sw. Lukasza w Kartuzach
Kartuzy, , Poland
Care Clinic Sp. z o.o.
Katowice, , Poland
Silmedic Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
Oświęcim, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Clinic of Dermatovenerology "Prof. Zecevic"
Belgrade, , Serbia
Institute of Rheumatology
Belgrade, , Serbia
Polyclinic Medikom
Belgrade, , Serbia
Institute of Treatment and Rehabilitation "Niska Banja"
Niška Banja, , Serbia
AAGS s.r.o., Reumatologicka ambulancia
Dunajská Streda, , Slovakia
MUDr. Zuzana Cizmarikova s.r.o. , Reumatologicka ambulancia
Poprad, , Slovakia
Nestatna reumatologicka ambulancia
Považská Bystrica, , Slovakia
Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.
Žilina, , Slovakia
Countries
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References
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Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.
Robinson MF, Damjanov N, Stamenkovic B, Radunovic G, Kivitz A, Cox L, Manukyan Z, Banfield C, Saunders M, Chandra D, Vincent MS, Mancuso J, Peeva E, Beebe JS. Efficacy and Safety of PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor, in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2020 Oct;72(10):1621-1631. doi: 10.1002/art.41316. Epub 2020 Sep 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
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Other Identifiers
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2016-002862-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7981006
Identifier Type: -
Identifier Source: org_study_id
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