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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT02969044

Run by

Pfizer

People needed

70

Starts

2016-12-20

Expected to finish

2017-12-12

Last updated by the study team

2018-12-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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