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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT-Number: 2007-003508-36 |
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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.
Study with completed results acquired from Horizon in 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP01 | Experimental | Modified Release (MR) prednisone 5 mg |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR prednisone | Drug | 1 x 5 mg daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Associates of N. AL, P.C. | Huntsville | Alabama | 35801 | United States | ||
| ArthoCare, Arthritis Care & Research, P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26535146 | Derived | 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. | |
| 22562974 | Derived |
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The study consisted of a 1 week screening phase followed by a 12 week double blind treatment phase. In addition to their standard RA medication, patients received placebo during the 1 week screening phase. The purpose of the screening phase was to establish the patient's compliance with study medication and completion of diary entries.
Approximately 350 patients were to be enrolled (at screening, Visit 0), with a minimum of 6 and a maximum of 28 patients at each center. It was planned to randomize (at Visit 1) a total of 294 patients in 50-55 centers in North America and Europe (Germany, Hungary, Poland and UK). First patient enrolled March, 2008; last patient contact May, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | NP01 | Modified Release (MR) prednisone 5 mg |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
1x daily |
|
| Week 12 |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| The National Institute of Clinical Research | Los Angeles | California | 90057 | United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| Blue Hill Medical Group | Pacific Palisades | California | 90272 | United States |
| San Diego Arthritis Medical Clinic | San Diego | California | 92108 | United States |
| Boling Clinical Trials | Upland | California | 91786 | United States |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80909 | United States |
| Front Range Clinical Research | Wheat Ridge | Colorado | 80033 | United States |
| Arthritis Center | Palm Harbor | Florida | 34684 | United States |
| West Broward Rheumatology Associates, Inc. | Tamarac | Florida | 33321 | United States |
| Southwest Florida Clinical Research Center | Tampa | Florida | 33609 | United States |
| Tampa Medical Group, PA | Tampa | Florida | 33614 | United States |
| Geodyssey Research, LLC | Vero Beach | Florida | 32962 | United States |
| The Arthritis Center | Springfield | Illinois | 62704 | United States |
| Center for Arthritis and Osteoporosis | Elizabethtown | Kentucky | 42701 | United States |
| Phase III Clinical Research | Fall River | Massachusetts | 02720 | United States |
| Montana Health Research Institute, Inc. | Billings | Montana | 59102 | United States |
| Arthritis Center of Reno | Reno | Nevada | 89502 | United States |
| Arthritis Associates | Belmont | North Carolina | 28012 | United States |
| Clinical Research Source | Perrysburg | Ohio | 43551 | United States |
| Health Resources of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| DeGarmo Institute of Medical Research | Greer | South Carolina | 29651 | United States |
| Carolina Center for Rheumatology & Arthritis Care | Rock Hill | South Carolina | 29732 | United States |
| SCRI-Marker | Memphis | Tennessee | 38119 | United States |
| Radiant Research of San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| Arthritis & Osteoporosis Cntr. Of S. TX | San Antonio | Texas | 78232 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Clinical Research and Arthritis Centre | Windsor | Ontario | N8X 5A6 | Canada |
| Kerckhoff-Klinik | Bad Nauheim | 61231 | Germany |
| Charité Campus Mitte, Dept. of Rheumatology and Clinical Immunology | Berlin | 10117 | Germany |
| Schlosspark-Klinik | Berlin | 14059 | Germany |
| Praxiszentrum, St.-Bonifatius-Straße | München | 81541 | Germany |
| Budai Irgalmasrendi Kórház | Budapest | 1027 | Hungary |
| Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék | Debrecen | 4004 | Hungary |
| Kenézy Gyula Kórház-Rendelőintézet, Reumatológiai Osztály | Debrecen | 4043 | Hungary |
| Bács-Kiskun Megyei Kórház, Reumatológiai Osztály | Kecskemét | 6000, | Hungary |
| Kiskunhalasi Semmelweis Kórház Kht., Reumatológiai Osztály | Kiskunhalas | 6400 | Hungary |
| Pécsi Tudományegyetem, Immunológiai és Reumatológiai Klinika | Pécs | 7602 | Hungary |
| MÁV Kórház Szolnok, Reumatológiai Osztály | Szolnok | 5000 | Hungary |
| Markusovszky Kórház, Reumatológiai Osztály Szombathely | Szombathely | 9700 | Hungary |
| Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanisława Sierakowskiego | Bialystok | 15-296 | Poland |
| NZOZ Centrum Medyczne Artur Racewicz | Bialystok | 15-337 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej | Lublin | 20-954 | Poland |
| Zaklad Opieki Zdrowotnej, Poznan - Stare Miastro, Szpital im. Józefa Strusia, Oddzial Reumatologii i Osteoporozy | Poznan | 61-833 | Poland |
| Wojewódzki Zespol Reumatologiczny im. Dr Jadwigi Titz-Kosko w Sopocie | Sopot | 81-759 | Poland |
| NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna | Torun | 87-100 | Poland |
| Centrum Leczenia Chorób Cywilizacyjnych | Warsaw | 02-777 | Poland |
| Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | 50-556 | Poland |
| University of Bristol, Academic Rheumatology Unit | Bristol | BS2 8 HW | United Kingdom |
| Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Diana Princess of Wales Hospital | Lincolnshire | DN33 2BA | United Kingdom |
| Arrowe Park Hospital | Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NP01 | Modified Release (MR) prednisone 5 mg |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. All missing values were imputed as non-responders. | Posted | Number | participants | Week 12 |
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| 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). | Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. Excludes those participants with missing data. Analysis used last observation carried forward imputation. | Posted | Median | 95% Confidence Interval | Relative Change from Baseline (%) | Week 12 |
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Initiation of double blind treatment until end of treatment or 30 days after last study drug administration, whicever occurred later
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NP01 | Modified Release (MR) prednisone 5 mg | 1 | 231 | 69 | 231 | ||
| EG001 | Placebo | 2 | 119 | 49 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial ischaemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| chest discomfort | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| cytology abnormal | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment | Includes rheumatoid arthritis aggravated and rheumatoid arthritis flare-up(MedDRA lowest level term) |
|
| nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| hematuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
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The first publication shall be the presentation of a joint, multicenter publication of the Study results. If such a multicenter publication is not submitted within 24 months after conclusion of the Study at all sites, INSTITUTION/INVESTIGATOR may publish the results from the INSTITUTION'S site individually, provided that it is submitted to SPONSOR for review and comment 60 days prior to submission for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Clinical Development & Operations | Horizon Pharma | 224-383-3012 | agrahn@horizonpharma.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D012816 | Signs and Symptoms |
| D001327 | Autoimmune Diseases |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D003240 | Connective Tissue Diseases |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Hungary |
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| Canada |
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| Poland |
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| Germany |
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| United Kingdom |
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