At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 147 enrolled
Drug / intervention
Lodotra®drug
Likely dose
Lodotra® 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness
In Brief
A Phase 4 clinical trial evaluating Lodotra® for Rheumatoid Arthritis. Completed, enrolled 147 participants across 1 site.
Detailed Summary
This study is multicenter, Ph IV, single arm, interventional study to assess relative reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after 2, 6 and 12 weeks after treatment (visit 2,3,4).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedFeb 2014
Primary CompletionApr 2015
TodayJul 2026
First PostedFeb 26, 2014
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.3 years ago
Interventions
Lodotra®drug
Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response