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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: MR prednisone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NP01<br>Modified Release (MR) prednisone 5 mg | Drug: MR prednisone<br>* 1 x 5 mg daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1x daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR 20 Response Rate at Visit 4 | 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 | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Reduction of Morning Stiffness | 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). | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Signs and Symptoms, Autoimmune Diseases, Joint Diseases, Arthritis, Connective Tissue Diseases, Arthritis, Rheumatoid, Rheumatic Diseases, Predniso(lo)ne