Rheumatoid Arthritis Clinical Trial
Official title:
A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness
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).
Test Treatment, Dose, and Mode of Administration:
Starting dose is 10mg, and depending on the clinical symptoms and the patient's response,
the initial dose can quickly be reduced to a lower maintenance dose. When changing over from
the standard regimen (glucocorticoid administration in the morning) to Lodotra® administered
at bedtime (at about 10 pm), the same dose (in mg prednisone equivalent) should be
maintained, if the subject has taken stable dose within 30 days. Lodotra® dose cannot exceed
more than 10mg.
Lodotra® should be taken at bedtime (at about 10 pm), with or after the evening meal and be
swallowed whole with sufficient liquid. If more than 2 - 3 hours have passed since the
evening meal, it is recommended to take Lodotra® with a light meal or snack.
Modified-release tablets are not to be broken, divided or chewed.
Treatment procedure:At Visit 1(week 0), subjects who qualify for entry into the study will
medicated to Lodotra® starting dose of 10 mg daily. (Written informed consent has to be
obtained, and subjects will undergo complete evaluation for study eligibility) No dose
increase will be allowed for more than 10mg
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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