Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

Completed · Phase 3

Conditions studied: Arthritis, Rheumatoid

In brief

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Key facts

Study ID

NCT01039688

Run by

Pfizer

People needed

956

Starts

2010-01-01

Expected to finish

2013-03-01

Last updated by the study team

2018-04-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
• Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
• Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

You may not qualify if…

• Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
• History of any other rheumatic autoimmune disease other than Sjogren's syndrome
• No malignancy or history of malignancy
• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
• No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

Where it is running

• Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
• University of California San Diego Perlman Ambulatory Clinic — La Jolla, California, United States
• University of California San Diego Center for Innovative Therapy — La Jolla, California, United States
• Keck Hospital of USC, Lower Level Pharmacy — Los Angeles, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• USC Keck School of Medicine — Los Angeles, California, United States
• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• Southeastern Arthritis Center — Gainesville, Florida, United States
• Southeastern Imaging and Diagnostics — Gainesville, Florida, United States
• Southeastern Integrated Medical, PL dba Florida Medical Research — Gainesville, Florida, United States
• Center for Arthritis and Rheumatic Diseases — Miami, Florida, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States
• Bernard F. Germain, MD — Tampa, Florida, United States
• Burnette & Silverfield, MDS PLC — Tampa, Florida, United States
• Diagnostic Rheumatology and Research, PC — Indianapolis, Indiana, United States
• Medical Associates Clinic, PC — Dubuque, Iowa, United States
• Louisiana State University Health Sciences — New Orleans, Louisiana, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• The Center for Rheumatology — Albany, New York, United States
• AAIR Research Center — Rochester, New York, United States
• PMG Research of Hickory, LLC — Hickory, North Carolina, United States
• Catalina Pointe Clinical Research, Inc. — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.