Phase 3
Completed N=350
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00650078 ↗Enrolled (actual)
350
Serious AEs
0.9%
Results posted
Dec 2012
Primary outcomePrimary: ACR 20 Response Rate at Visit 4 — 108; 34 participants — p=0.0010
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-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACR 20 Response Rate at Visit 4 |
108; 34 | 0.0010 sig |
| SECONDARY Relative Reduction of Morning Stiffness |
-55.22; -34.62 | 0.0015 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00650078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.