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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00650078

Public ClinicalTrials.gov record NCT00650078. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00650078
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amgen
Industry
Enrollment
350 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 29, 2008
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009
Last update posted
Dec 17, 2024

2008 – 2009

United States locations

U.S. sites
28
U.S. states
17
U.S. cities
25
Facility City State ZIP Site status
Rheumatology Associates of N. AL, P.C. Huntsville Alabama 35801
ArthoCare, Arthritis Care & Research, P.C. Phoenix Arizona 85012
The National Institute of Clinical Research Los Angeles California 90057
University of California, Los Angeles Los Angeles California 90095
Blue Hill Medical Group Pacific Palisades California 90272
San Diego Arthritis Medical Clinic San Diego California 92108
Boling Clinical Trials Upland California 91786
Lynn Institute of the Rockies Colorado Springs Colorado 80909
Front Range Clinical Research Wheat Ridge Colorado 80033
Arthritis Center Palm Harbor Florida 34684
West Broward Rheumatology Associates, Inc. Tamarac Florida 33321
Southwest Florida Clinical Research Center Tampa Florida 33609
Tampa Medical Group, PA Tampa Florida 33614
Geodyssey Research, LLC Vero Beach Florida 32962
The Arthritis Center Springfield Illinois 62704
Center for Arthritis and Osteoporosis Elizabethtown Kentucky 42701
Phase III Clinical Research Fall River Massachusetts 02720
Montana Health Research Institute, Inc. Billings Montana 59102
Arthritis Center of Reno Reno Nevada 89502
Arthritis Associates Belmont North Carolina 28012
Clinical Research Source Perrysburg Ohio 43551
Health Resources of Oklahoma Oklahoma City Oklahoma 73103
DeGarmo Institute of Medical Research Greer South Carolina 29651
Carolina Center for Rheumatology & Arthritis Care Rock Hill South Carolina 29732
SCRI-Marker Memphis Tennessee 38119
Radiant Research of San Antonio Northeast San Antonio Texas 78217
Arthritis & Osteoporosis Cntr. Of S. TX San Antonio Texas 78232
Northwest Clinical Research Center Bellevue Washington 98004

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00650078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00650078 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →