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

Rheumatoid Arthritis Clinical Trial

— CAPRA-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650078
• Other study ID #: NP01-007
• Secondary ID: EudraCT-Number:
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2008
• Last updated: April 23, 2013
• Start date: March 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2013
• Source: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 a (TNFa) inhibitors and other compounds within 5 serum half lives prior to screening visit

• Pregnancy or nursing

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MR prednisone
1 x 5 mg daily
• Placebo
1x daily

Locations

Country	Name	City	State
Canada	Clinical Research and Arthritis Centre	Windsor	Ontario
Germany	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
Hungary	Budai Irgalmasrendi Kórház	Budapest
Hungary	Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék	Debrecen
Hungary	Kenézy Gyula Kórház-Rendelointézet, 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
Poland	Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanislawa 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	Warszawa
Poland	Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
United Kingdom	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	Wirral
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Arthritis Associates	Belmont	North Carolina
United States	Montana Health Research Institute, Inc.	Billings	Montana
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Center for Arthritis and Osteoporosis	Elizabethtown	Kentucky
United States	Phase III Clinical Research	Fall River	Massachusetts
United States	DeGarmo Institute of Medical Research	Greer	South Carolina
United States	Rheumatology Associates of N. AL, P.C.	Huntsville	Alabama
United States	The National Institute of Clinical Research	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	SCRI-Marker	Memphis	Tennessee
United States	Health Resources of Oklahoma	Oklahoma City	Oklahoma
United States	Blue Hill Medical Group	Pacific Palisades	California
United States	Arthritis Center	Palm Harbor	Florida
United States	Clinical Research Source	Perrysburg	Ohio
United States	ArthoCare, Arthritis Care & Research, P.C.	Phoenix	Arizona
United States	Arthritis Center of Reno	Reno	Nevada
United States	Carolina Center for Rheumatology & Arthritis Care	Rock Hill	South Carolina
United States	Arthritis & Osteoporosis Cntr. Of S. TX	San Antonio	Texas
United States	Radiant Research of San Antonio Northeast	San Antonio	Texas
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	The Arthritis Center	Springfield	Illinois
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	Boling Clinical Trials	Upland	California
United States	Geodyssey Research, LLC	Vero Beach	Florida
United States	Front Range Clinical Research	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Pharma Ireland, Ltd., Dublin Ireland

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR 20 Response Rate at Visit 4	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	Week 12	No
Secondary	Relative Reduction of Morning Stiffness	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).	Week 12	No