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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: MR prednisone; Drug: Placebo

• Registration Number: NCT00650078
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Study with completed results acquired from Horizon in 2024.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Disposition First Submitted: 2011-03-15
• Disposition First Submitted QC: 2011-03-15
• Disposition First Posted: 2011-03-25
• Results First Submitted: 2012-11-01
• Results First Submitted QC: 2012-11-15
• Results First Posted: 2012-12-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NP01	MR prednisone	Modified Release (MR) prednisone 5 mg
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
ACR 20 Response Rate at Visit 4	Week 12	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

Secondary Outcome Measures

Name	Time	Method
Relative Reduction of Morning Stiffness	Week 12	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).

Trial Locations

Locations (52)

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej; 🇵🇱 Lublin, Poland

Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék; 🇭🇺 Debrecen, Hungary

MÁV Kórház Szolnok, Reumatológiai Osztály; 🇭🇺 Szolnok, Hungary

NZOZ Centrum Medyczne Artur Racewicz; 🇵🇱 Białystok, Poland

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu; 🇵🇱 Wrocław, Poland

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Montana Health Research Institute, Inc.; 🇺🇸 Billings, Montana, United States

SCRI-Marker; 🇺🇸 Memphis, Tennessee, United States

Kenézy Gyula Kórház-Rendelőintézet, Reumatológiai Osztály; 🇭🇺 Debrecen, Hungary

Arthritis Center of Reno; 🇺🇸 Reno, Nevada, United States

Wojewódzki Zespol Reumatologiczny im. Dr Jadwigi Titz-Kosko w Sopocie; 🇵🇱 Sopot, Poland

Carolina Center for Rheumatology & Arthritis Care; 🇺🇸 Rock Hill, South Carolina, United States

NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna; 🇵🇱 Toruń, Poland

ArthoCare, Arthritis Care & Research, P.C.; 🇺🇸 Phoenix, Arizona, United States

DeGarmo Institute of Medical Research; 🇺🇸 Greer, South Carolina, United States

Bács-Kiskun Megyei Kórház, Reumatológiai Osztály; 🇭🇺 Kecskemét, Hungary

Zaklad Opieki Zdrowotnej, Poznan - Stare Miastro, Szpital im. Józefa Strusia, Oddzial Reumatologii i Osteoporozy; 🇵🇱 Poznań, Poland

Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanisława Sierakowskiego; 🇵🇱 Białystok, Poland

Rheumatology Associates of N. AL, P.C.; 🇺🇸 Huntsville, Alabama, United States

San Diego Arthritis Medical Clinic; 🇺🇸 San Diego, California, United States

Southwest Florida Clinical Research Center; 🇺🇸 Tampa, Florida, United States

Blue Hill Medical Group; 🇺🇸 Pacific Palisades, California, United States

Arthritis Center; 🇺🇸 Palm Harbor, Florida, United States

West Broward Rheumatology Associates, Inc.; 🇺🇸 Tamarac, Florida, United States

Phase III Clinical Research; 🇺🇸 Fall River, Massachusetts, United States

The National Institute of Clinical Research; 🇺🇸 Los Angeles, California, United States

Front Range Clinical Research; 🇺🇸 Wheat Ridge, Colorado, United States

Lynn Institute of the Rockies; 🇺🇸 Colorado Springs, Colorado, United States

Boling Clinical Trials; 🇺🇸 Upland, California, United States

Tampa Medical Group, PA; 🇺🇸 Tampa, Florida, United States

The Arthritis Center; 🇺🇸 Springfield, Illinois, United States

Geodyssey Research, LLC; 🇺🇸 Vero Beach, Florida, United States

Center for Arthritis and Osteoporosis; 🇺🇸 Elizabethtown, Kentucky, United States

Arthritis Associates; 🇺🇸 Belmont, North Carolina, United States

Clinical Research Source; 🇺🇸 Perrysburg, Ohio, United States

Arthritis & Osteoporosis Cntr. Of S. TX; 🇺🇸 San Antonio, Texas, United States

Radiant Research of San Antonio Northeast; 🇺🇸 San Antonio, Texas, United States

Clinical Research and Arthritis Centre; 🇨🇦 Windsor, Ontario, Canada

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

Schlosspark-Klinik; 🇩🇪 Berlin, Germany

Charité Campus Mitte, Dept. of Rheumatology and Clinical Immunology; 🇩🇪 Berlin, Germany

Budai Irgalmasrendi Kórház; 🇭🇺 Budapest, Hungary

Praxiszentrum, St.-Bonifatius-Straße; 🇩🇪 München, Germany

Pécsi Tudományegyetem, Immunológiai és Reumatológiai Klinika; 🇭🇺 Pécs, Hungary

Kiskunhalasi Semmelweis Kórház Kht., Reumatológiai Osztály; 🇭🇺 Kiskunhalas, Hungary

Markusovszky Kórház, Reumatológiai Osztály Szombathely; 🇭🇺 Szombathely, Hungary

Centrum Leczenia Chorób Cywilizacyjnych; 🇵🇱 Warszawa, Poland

University of Bristol, Academic Rheumatology Unit; 🇬🇧 Bristol, United Kingdom

Arrowe Park Hospital; 🇬🇧 Wirral, United Kingdom

Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Diana Princess of Wales Hospital; 🇬🇧 Lincolnshire, United Kingdom

Health Resources of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States