Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.

Key facts

Study ID

NCT00650078

Run by

Amgen

People needed

350

Starts

2008-03-01

Expected to finish

2009-05-01

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented history of RA in agreement with ACR criteria
• DMARD treatment for RA greater than or equal to 6 months, with a stable dose greater than or equal to 6 weeks prior to screening visit
• Duration of morning stiffness greater than or equal to 45 minutes
• greater than or equal to 4 swollen joints (out of 28)
• greater than or equal to 4 tender joints (out of 28)

You may not qualify if…

• Suffering from another disease, which requires glucocorticoid treatment during the study period
• Synovectomy within 4 months prior to study start
• Use of glucocorticoids:
• Continued use of systemic glucocorticoids within 4 weeks prior to screening visit
• Intermittent use of glucocorticoids within 2 weeks prior to screening visit.
• Joint injections within 6 weeks prior to screening visit
• Topical glucocorticoids must be stopped at screening visit
• Use of biologicals such as: tumor necrosis factor α (TNFα) inhibitors and other compounds within 5 serum half lives prior to screening visit
• Pregnancy or nursing

Where it is running

• ArthoCare, Arthritis Care & Research, P.C. — Phoenix, Arizona, United States
• The National Institute of Clinical Research — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Blue Hill Medical Group — Pacific Palisades, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Boling Clinical Trials — Upland, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Front Range Clinical Research — Wheat Ridge, Colorado, United States
• Arthritis Center — Palm Harbor, Florida, United States
• West Broward Rheumatology Associates, Inc. — Tamarac, Florida, United States
• Southwest Florida Clinical Research Center — Tampa, Florida, United States
• Tampa Medical Group, PA — Tampa, Florida, United States
• Geodyssey Research, LLC — Vero Beach, Florida, United States
• The Arthritis Center — Springfield, Illinois, United States
• Center for Arthritis and Osteoporosis — Elizabethtown, Kentucky, United States
• Phase III Clinical Research — Fall River, Massachusetts, United States
• Montana Health Research Institute, Inc. — Billings, Montana, United States
• Arthritis Center of Reno — Reno, Nevada, United States
• Arthritis Associates — Belmont, North Carolina, United States
• Clinical Research Source — Perrysburg, Ohio, United States
• Health Resources of Oklahoma — Oklahoma City, Oklahoma, United States
• DeGarmo Institute of Medical Research — Greer, South Carolina, United States
• Carolina Center for Rheumatology & Arthritis Care — Rock Hill, South Carolina, United States
• SCRI-Marker — Memphis, Tennessee, United States
• Rheumatology Associates of N. AL, P.C. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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