Status:
COMPLETED
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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-R...
Detailed Description
Study with completed results acquired from Horizon in 2024.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00650078
Start Date
March 1 2008
End Date
May 1 2009
Last Update
December 18 2024
Active Locations (52)
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1
Rheumatology Associates of N. AL, P.C.
Huntsville, Alabama, United States, 35801
2
ArthoCare, Arthritis Care & Research, P.C.
Phoenix, Arizona, United States, 85012
3
The National Institute of Clinical Research
Los Angeles, California, United States, 90057
4
University of California, Los Angeles
Los Angeles, California, United States, 90095