Back to resultsStudy to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis (CAPRA-2)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MR prednisone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Signs and Symptoms, Autoimmune Diseases, Joint Diseases, Arthritis, Connective Tissue Diseases, Arthritis, Rheumatoid, Rheumatic Diseases, Predniso(lo)ne
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
Sites / Locations
- Rheumatology Associates of N. AL, P.C.
- ArthoCare, Arthritis Care & Research, P.C.
- The National Institute of Clinical Research
- University of California, Los Angeles
- Blue Hill Medical Group
- San Diego Arthritis Medical Clinic
- Boling Clinical Trials
- Lynn Institute of the Rockies
- Front Range Clinical Research
- Arthritis Center
- West Broward Rheumatology Associates, Inc.
- Southwest Florida Clinical Research Center
- Tampa Medical Group, PA
- Geodyssey Research, LLC
- The Arthritis Center
- Center for Arthritis and Osteoporosis
- Phase III Clinical Research
- Montana Health Research Institute, Inc.
- Arthritis Center of Reno
- Arthritis Associates
- Clinical Research Source
- Health Resources of Oklahoma
- DeGarmo Institute of Medical Research
- Carolina Center for Rheumatology & Arthritis Care
- SCRI-Marker
- Radiant Research of San Antonio Northeast
- Arthritis & Osteoporosis Cntr. Of S. TX
- Northwest Clinical Research Center
- Clinical Research and Arthritis Centre
- Kerckhoff-Klinik
- Charité Campus Mitte, Dept. of Rheumatology and Clinical Immunology
- Schlosspark-Klinik
- Praxiszentrum, St.-Bonifatius-Straße
- Budai Irgalmasrendi Kórház
- Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék
- Kenézy Gyula Kórház-Rendelőintézet, Reumatológiai Osztály
- Bács-Kiskun Megyei Kórház, Reumatológiai Osztály
- Kiskunhalasi Semmelweis Kórház Kht., Reumatológiai Osztály
- Pécsi Tudományegyetem, Immunológiai és Reumatológiai Klinika
- MÁV Kórház Szolnok, Reumatológiai Osztály
- Markusovszky Kórház, Reumatológiai Osztály Szombathely
- Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanisława Sierakowskiego
- NZOZ Centrum Medyczne Artur Racewicz
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
- Zaklad Opieki Zdrowotnej, Poznan - Stare Miastro, Szpital im. Józefa Strusia, Oddzial Reumatologii i Osteoporozy
- Wojewódzki Zespol Reumatologiczny im. Dr Jadwigi Titz-Kosko w Sopocie
- NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
- Centrum Leczenia Chorób Cywilizacyjnych
- Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
- University of Bristol, Academic Rheumatology Unit
- Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Diana Princess of Wales Hospital
- Arrowe Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NP01
Placebo
Arm Description
Modified Release (MR) prednisone 5 mg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00650078
First Posted
March 28, 2008
Last Updated
April 23, 2013
Sponsor
Horizon Pharma Ireland, Ltd., Dublin Ireland
1. Study Identification
Unique Protocol Identification Number
NCT00650078
Brief Title
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horizon Pharma Ireland, Ltd., Dublin Ireland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Signs and Symptoms, Autoimmune Diseases, Joint Diseases, Arthritis, Connective Tissue Diseases, Arthritis, Rheumatoid, Rheumatic Diseases, Predniso(lo)ne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NP01
Arm Type
Experimental
Arm Description
Modified Release (MR) prednisone 5 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MR prednisone
Intervention Description
1 x 5 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1x daily
Primary Outcome Measure Information:
Title
ACR 20 Response Rate at Visit 4
Description
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
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Relative Reduction of Morning Stiffness
Description
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).
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Buttgereit, Prof. Dr.
Organizational Affiliation
Charité Campus Mitte, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Associates of N. AL, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
ArthoCare, Arthritis Care & Research, P.C.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
The National Institute of Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Blue Hill Medical Group
City
Pacific Palisades
State/Province
California
ZIP/Postal Code
90272
Country
United States
Facility Name
San Diego Arthritis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Boling Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Front Range Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
West Broward Rheumatology Associates, Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Southwest Florida Clinical Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Tampa Medical Group, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Geodyssey Research, LLC
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32962
Country
United States
Facility Name
The Arthritis Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Center for Arthritis and Osteoporosis
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Phase III Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Montana Health Research Institute, Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Arthritis Center of Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Arthritis Associates
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
Facility Name
Clinical Research Source
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Health Resources of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
DeGarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Carolina Center for Rheumatology & Arthritis Care
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
SCRI-Marker
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Radiant Research of San Antonio Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Arthritis & Osteoporosis Cntr. Of S. TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Clinical Research and Arthritis Centre
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charité Campus Mitte, Dept. of Rheumatology and Clinical Immunology
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Schlosspark-Klinik
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Praxiszentrum, St.-Bonifatius-Straße
City
München
ZIP/Postal Code
81541
Country
Germany
Facility Name
Budai Irgalmasrendi Kórház
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Kenézy Gyula Kórház-Rendelőintézet, Reumatológiai Osztály
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Bács-Kiskun Megyei Kórház, Reumatológiai Osztály
City
Kecskemét
ZIP/Postal Code
6000,
Country
Hungary
Facility Name
Kiskunhalasi Semmelweis Kórház Kht., Reumatológiai Osztály
City
Kiskunhalas
ZIP/Postal Code
6400
Country
Hungary
Facility Name
Pécsi Tudományegyetem, Immunológiai és Reumatológiai Klinika
City
Pécs
ZIP/Postal Code
7602
Country
Hungary
Facility Name
MÁV Kórház Szolnok, Reumatológiai Osztály
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Markusovszky Kórház, Reumatológiai Osztály Szombathely
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanisława Sierakowskiego
City
Białystok
ZIP/Postal Code
15-296
Country
Poland
Facility Name
NZOZ Centrum Medyczne Artur Racewicz
City
Białystok
ZIP/Postal Code
15-337
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Zaklad Opieki Zdrowotnej, Poznan - Stare Miastro, Szpital im. Józefa Strusia, Oddzial Reumatologii i Osteoporozy
City
Poznań
ZIP/Postal Code
61-833
Country
Poland
Facility Name
Wojewódzki Zespol Reumatologiczny im. Dr Jadwigi Titz-Kosko w Sopocie
City
Sopot
ZIP/Postal Code
81-759
Country
Poland
Facility Name
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Leczenia Chorób Cywilizacyjnych
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
University of Bristol, Academic Rheumatology Unit
City
Bristol
ZIP/Postal Code
BS2 8 HW
Country
United Kingdom
Facility Name
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Diana Princess of Wales Hospital
City
Lincolnshire
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26535146
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.
Results Reference
derived
PubMed Identifier
22562974
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.
Results Reference
derived
Learn more about this trial
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
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