Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

Key facts

Study ID

NCT01164579

Run by

Pfizer

People needed

109

Starts

2010-10-01

Expected to finish

2013-11-01

Last updated by the study team

2015-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive.

You may not qualify if…

• Pregnant or lactating patients;
• Patients with renal or hepatic impairment or other severe or progressing disease;
• Patients with contraindication to magnetic resonance imaging with gadolinium contrast.

Where it is running

• ArthroCare, Arthritis Care & Research, PC — Gilbert, Arizona, United States
• Talbert Medical Group — Huntington Beach, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Millennium Research — Ormond Beach, Florida, United States
• DMI Research, Inc. — Pinellas Park, Florida, United States
• St. Petersburg Arthritis Center — St. Petersburg, Florida, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Office of John P. Lavery, MD, PA — Allen, Texas, United States
• OMI - Organización Médica de Investigación — Buenos Aires, Argentina
• Saint Dennis Medical Group S.A. — Buenos Aires, Argentina
• Consultorios Reumatologicos Pampa — Buenos Aires, Argentina
• Consulta Privada Dr. Juan Ignacio Vargas — Osorno, Los Lagos Region, Chile
• Hospital Base Valdivia — Valdivia, Region XIV, Chile
• University Hospital Centre Split,Department for Internal Medicine, Division of Clinical Rheumatology — Split, Croatia
• General Hospital Sveti Duh — Zagreb, Croatia
• ARTMEDI UPD s r.o. — Hostivice, Czechia
• Nemocnice na Frantisku s poliklinikou — Prague, Czechia
• Nemocnice na Frantisku — Prague, Czechia
• Revmatologicky ustav — Prague, Czechia
• DC Mediscan — Praha 11 - Chodov, Czechia
• Uherskohradistska nemocnice, a.s. — Uherské Hradiště, Czechia
• Nemocnice Atlas, a.s. — Zlín, Czechia
• PV-Medical s.r.o. — Zlín, Czechia
• Drug Research Center Kft. — Balatonfüred, Hungary
• Orszagos Reumatologiai es Fizioterapias Intezet — Budapest, Hungary

Full record on ClinicalTrials.gov

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