Clinical trial NCT00650078: Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Signs and Symptoms
Autoimmune Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Predniso(lo)ne
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: ACR 20 Response Rate at Visit 4
timeFrame: Week 12
Secondary outcomes:
measure: Relative Reduction of Morning Stiffness
timeFrame: Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of N. AL, P.C.
state: Alabama
city: Phoenix
country: United States
facility: ArthoCare, Arthritis Care & Research, P.C.
state: Arizona
city: Los Angeles
country: United States
facility: The National Institute of Clinical Research
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Pacific Palisades
country: United States
facility: Blue Hill Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Upland
country: United States
facility: Boling Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Wheat Ridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Palm Harbor
country: United States
facility: Arthritis Center
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: Southwest Florida Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, PA
state: Florida
city: Vero Beach
country: United States
facility: Geodyssey Research, LLC
state: Florida
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Elizabethtown
country: United States
facility: Center for Arthritis and Osteoporosis
state: Kentucky
city: Fall River
country: United States
facility: Phase III Clinical Research
state: Massachusetts
city: Billings
country: United States
facility: Montana Health Research Institute, Inc.
state: Montana
city: Reno
country: United States
facility: Arthritis Center of Reno
state: Nevada
city: Belmont
country: United States
facility: Arthritis Associates
state: North Carolina
city: Perrysburg
country: United States
facility: Clinical Research Source
state: Ohio
city: Oklahoma City
country: United States
facility: Health Resources of Oklahoma
state: Oklahoma
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Center for Rheumatology & Arthritis Care
state: South Carolina
city: Memphis
country: United States
facility: SCRI-Marker
state: Tennessee
city: San Antonio
country: United States
facility: Radiant Research of San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: Arthritis & Osteoporosis Cntr. Of S. TX
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Windsor
country: Canada
facility: Clinical Research and Arthritis Centre
state: Ontario
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Berlin
country: Germany
facility: Charité Campus Mitte, Dept. of Rheumatology and Clinical Immunology
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: München
country: Germany
facility: Praxiszentrum, St.-Bonifatius-Straße
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék
city: Debrecen
country: Hungary
facility: Kenézy Gyula Kórház-Rendelőintézet, Reumatológiai Osztály
city: Kecskemét
country: Hungary
facility: Bács-Kiskun Megyei Kórház, Reumatológiai Osztály
city: Kiskunhalas
country: Hungary
facility: Kiskunhalasi Semmelweis Kórház Kht., Reumatológiai Osztály
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem, Immunológiai és Reumatológiai Klinika
city: Szolnok
country: Hungary
facility: MÁV Kórház Szolnok, Reumatológiai Osztály
city: Szombathely
country: Hungary
facility: Markusovszky Kórház, Reumatológiai Osztály Szombathely
city: Białystok
country: Poland
facility: Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanisława Sierakowskiego
city: Białystok
country: Poland
facility: NZOZ Centrum Medyczne Artur Racewicz
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
city: Poznań
country: Poland
facility: Zaklad Opieki Zdrowotnej, Poznan - Stare Miastro, Szpital im. Józefa Strusia, Oddzial Reumatologii i Osteoporozy
city: Sopot
country: Poland
facility: Wojewódzki Zespol Reumatologiczny im. Dr Jadwigi Titz-Kosko w Sopocie
city: Toruń
country: Poland
facility: NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorób Cywilizacyjnych
city: Wrocław
country: Poland
facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
city: Bristol
country: United Kingdom
facility: University of Bristol, Academic Rheumatology Unit
city: Lincolnshire
country: United Kingdom
facility: Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Diana Princess of Wales Hospital
city: Wirral
country: United Kingdom
facility: Arrowe Park Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.