Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.

Key facts

Study ID

NCT01393639

Run by

Pfizer

People needed

323

Starts

2011-09-27

Expected to finish

2014-06-09

Last updated by the study team

2024-09-04

Who can join

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

You may qualify if…

• Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection.

You may not qualify if…

• Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications;
• subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.

Where it is running

• C. Michael Neuwelt, MD, Inc. — San Leandro, California, United States
• Javed Rheumatology Associates, Inc. — Newark, Delaware, United States
• Allergy, Asthma, Arthritis, and Lung Center — Daytona Beach, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Alastair C. Kennedy, MD — Vero Beach, Florida, United States
• The Center for Arthritis and Rheumatism — Vero Beach, Florida, United States
• Arthritis and Osteoporosis Medical Associates, PLLC — Brooklyn, New York, United States
• Cincinnati Rheumatic Disease Study Group, Inc. — Cincinnati, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Low Country Rheumatology, PA — Charleston, South Carolina, United States
• Tricounty Radiology — Charleston, South Carolina, United States
• Accurate Clinical Research, Inc. — Houston, Texas, United States
• Arthritis Northwest, PLLC — Spokane, Washington, United States
• Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD — Pleven, Bulgaria
• Revmatologichno Otdelenie, MBAL - Plovdiv — Plovdiv, Bulgaria
• MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia — Sofia, Bulgaria
• MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia — Sofia, Bulgaria
• Hospital Pablo Tobon Uribe — Medellín, Antioquia, Colombia
• Reumalab S.A.S — Medellín, Antioquia, Colombia
• Centro Integral de Reumatologia e Inmunologia CIREI — Bogota, Cundinamarca, Colombia
• Preventive Care SAS — Chía, Cundinamarca, Colombia
• Revmatologie Bruntal, S.R.O. — Bruntál, Czechia
• Revmatologicka ambulance — Ostrava - Poruba, Czechia
• Revmatologicka ambulance — Prague, Czechia
• Catalina Pointe Clinical Research, Inc. — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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