Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
NCT ID: NCT00650078
Last Updated: 2024-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2008-03-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NP01
Modified Release (MR) prednisone 5 mg
MR prednisone
1 x 5 mg daily
Placebo
Placebo
1x daily
Interventions
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MR prednisone
1 x 5 mg daily
Placebo
1x daily
Eligibility Criteria
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Inclusion 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Rheumatology Associates of N. AL, P.C.
Huntsville, Alabama, United States
ArthoCare, Arthritis Care & Research, P.C.
Phoenix, Arizona, United States
The National Institute of Clinical Research
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Blue Hill Medical Group
Pacific Palisades, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Boling Clinical Trials
Upland, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Front Range Clinical Research
Wheat Ridge, Colorado, United States
Arthritis Center
Palm Harbor, Florida, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
Southwest Florida Clinical Research Center
Tampa, Florida, United States
Tampa Medical Group, PA
Tampa, Florida, United States
Geodyssey Research, LLC
Vero Beach, Florida, United States
The Arthritis Center
Springfield, Illinois, United States
Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky, United States
Phase III Clinical Research
Fall River, Massachusetts, United States
Montana Health Research Institute, Inc.
Billings, Montana, United States
Arthritis Center of Reno
Reno, Nevada, United States
Arthritis Associates
Belmont, North Carolina, United States
Clinical Research Source
Perrysburg, Ohio, United States
Health Resources of Oklahoma
Oklahoma City, Oklahoma, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, United States
Carolina Center for Rheumatology & Arthritis Care
Rock Hill, South Carolina, United States
SCRI-Marker
Memphis, Tennessee, United States
Radiant Research of San Antonio Northeast
San Antonio, Texas, United States
Arthritis & Osteoporosis Cntr. Of S. TX
San Antonio, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Clinical Research and Arthritis Centre
Windsor, Ontario, Canada
Kerckhoff-Klinik
Bad Nauheim, , Germany
Charité Campus Mitte, Dept. of Rheumatology and Clinical Immunology
Berlin, , Germany
Schlosspark-Klinik
Berlin, , Germany
Praxiszentrum, St.-Bonifatius-Straße
München, , Germany
Budai Irgalmasrendi Kórház
Budapest, , Hungary
Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék
Debrecen, , Hungary
Kenézy Gyula Kórház-Rendelőintézet, Reumatológiai Osztály
Debrecen, , Hungary
Bács-Kiskun Megyei Kórház, Reumatológiai Osztály
Kecskemét, , Hungary
Kiskunhalasi Semmelweis Kórház Kht., Reumatológiai Osztály
Kiskunhalas, , Hungary
Pécsi Tudományegyetem, Immunológiai és Reumatológiai Klinika
Pécs, , Hungary
MÁV Kórház Szolnok, Reumatológiai Osztály
Szolnok, , Hungary
Markusovszky Kórház, Reumatológiai Osztály Szombathely
Szombathely, , Hungary
Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanisława Sierakowskiego
Bialystok, , Poland
NZOZ Centrum Medyczne Artur Racewicz
Bialystok, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
Lublin, , Poland
Zaklad Opieki Zdrowotnej, Poznan - Stare Miastro, Szpital im. Józefa Strusia, Oddzial Reumatologii i Osteoporozy
Poznan, , Poland
Wojewódzki Zespol Reumatologiczny im. Dr Jadwigi Titz-Kosko w Sopocie
Sopot, , Poland
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Torun, , Poland
Centrum Leczenia Chorób Cywilizacyjnych
Warsaw, , Poland
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
University of Bristol, Academic Rheumatology Unit
Bristol, , United Kingdom
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Diana Princess of Wales Hospital
Lincolnshire, , United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, , United Kingdom
Countries
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References
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Alten R, Grahn A, Holt RJ, Rice P, Buttgereit F. Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis. RMD Open. 2015 Aug 13;1(1):e000134. doi: 10.1136/rmdopen-2015-000134. eCollection 2015.
Buttgereit F, Mehta D, Kirwan J, Szechinski J, Boers M, Alten RE, Supronik J, Szombati I, Romer U, Witte S, Saag KG. Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2). Ann Rheum Dis. 2013 Feb;72(2):204-10. doi: 10.1136/annrheumdis-2011-201067. Epub 2012 May 5.
Other Identifiers
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EudraCT-Number: 2007-003508-36
Identifier Type: -
Identifier Source: secondary_id
NP01-007
Identifier Type: -
Identifier Source: org_study_id