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

Phase 3

Completed

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-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.

Detailed Description: Study with completed results acquired from Horizon in 2024.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
NP01	MR prednisone	Modified Release (MR) prednisone 5 mg
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
ACR 20 Response Rate at Visit 4	Week 12	Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria: * \> 20% reduction in the tender joint count (0-28) * \> 20% reduction in the swollen joint count (0-28) * \> 20% reduction in 3 out of the 5 following additional measures: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Functional Disability Index of the Health Assessment Questionnaire * C-reactive protein or erythrocyte sedimentation rate

Secondary Outcome Measures

Name	Time	Method
Relative Reduction of Morning Stiffness	Week 12	Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0).

Locations (52): Rheumatology Associates of N. AL, P.C.
🇺🇸
Huntsville, Alabama, United States
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
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Rheumatology Associates of N. AL, P.C.
🇺🇸Huntsville, Alabama, United States