CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 enrolled
Drug / intervention
MR prednisone +1 moredrug
Likely dose
MR prednisone 5 mgfrom 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.

Search/NCT00650078
NCT00650078Phase 3Completed
CompareCT.gov

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

Amgen·interventional·Posted Apr 1, 2008·Updated Dec 18, 2024

In Brief

A Phase 3 clinical trial evaluating MR prednisone and Placebo for Rheumatoid Arthritis. Completed, enrolled 350 participants across 52 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCanada, Germany, Hungary, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 1, 2008
Enrollment StartMar 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.3 years ago

Interventions

MR prednisonedrug

1 x 5 mg daily

Placebodrug

1x daily