Rheumatoid ArthritisPhase 3CAPRA-2NCT00650078
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
A Phase 3 study testing MR prednisone in people with Rheumatoid Arthritis, run by Amgen at 52 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- MR prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 52 sitesin 6 countries
- Study dates
- Mar 2008to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
52 sites in 6 countries.
52 sites in 6 countries
United States28 sites
Northwest Clinical Research Center
Bellevue, Washington, 98004
Arthritis Associates
Belmont, North Carolina, 28012
Montana Health Research Institute, Inc.
Billings, Montana, 59102
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky, 42701
Phase III Clinical Research
Fall River, Massachusetts, 02720
DeGarmo Institute of Medical Research
Greer, South Carolina, 29651
Rheumatology Associates of N. AL, P.C.
Huntsville, Alabama, 35801
The National Institute of Clinical Research
Los Angeles, California, 90057
University of California, Los Angeles
Los Angeles, California, 90095
SCRI-Marker
Memphis, Tennessee, 38119
Health Resources of Oklahoma
Oklahoma City, Oklahoma, 73103
Blue Hill Medical Group
Pacific Palisades, California, 90272
Arthritis Center
Palm Harbor, Florida, 34684
Clinical Research Source
Perrysburg, Ohio, 43551
ArthoCare, Arthritis Care & Research, P.C.
Phoenix, Arizona, 85012
Arthritis Center of Reno
Reno, Nevada, 89502
Carolina Center for Rheumatology & Arthritis Care
Rock Hill, South Carolina, 29732
Radiant Research of San Antonio Northeast
San Antonio, Texas, 78217
Arthritis & Osteoporosis Cntr. Of S. TX
San Antonio, Texas, 78232
San Diego Arthritis Medical Clinic
San Diego, California, 92108
The Arthritis Center
Springfield, Illinois, 62704
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321
Southwest Florida Clinical Research Center
Tampa, Florida, 33609
Tampa Medical Group, PA
Tampa, Florida, 33614
Boling Clinical Trials
Upland, California, 91786
Geodyssey Research, LLC
Vero Beach, Florida, 32962
Front Range Clinical Research
Wheat Ridge, Colorado, 80033
Hungary8 sites
Budai Irgalmasrendi Kórház
Budapest, 1027
Debreceni Egyetem, III. Belgyógyászati Klinika, Reumatológiai Tanszék
Debrecen, 4004
Kenézy Gyula Kórház-Rendelőintézet, Reumatológiai Osztály
Debrecen, 4043
Bács-Kiskun Megyei Kórház, Reumatológiai Osztály
Kecskemét, 6000,
Kiskunhalasi Semmelweis Kórház Kht., Reumatológiai Osztály
Kiskunhalas, 6400
Pécsi Tudományegyetem, Immunológiai és Reumatológiai Klinika
Pécs, 7602
MÁV Kórház Szolnok, Reumatológiai Osztály
Szolnok, 5000
Markusovszky Kórház, Reumatológiai Osztály Szombathely
Szombathely, 9700
Poland8 sites
Centrum Miriada, Prywatny Gabinet Specjalistyczny Prof. Dr. Stanisława Sierakowskiego
Bialystok, 15-296
NZOZ Centrum Medyczne Artur Racewicz
Bialystok, 15-337
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
Lublin, 20-954
Zaklad Opieki Zdrowotnej, Poznan - Stare Miastro, Szpital im. Józefa Strusia, Oddzial Reumatologii i Osteoporozy
Poznan, 61-833
Wojewódzki Zespol Reumatologiczny im. Dr Jadwigi Titz-Kosko w Sopocie
Sopot, 81-759
NZOZ "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Torun, 87-100
Centrum Leczenia Chorób Cywilizacyjnych
Warsaw, 02-777
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
Germany4 sites
Kerckhoff-Klinik
Bad Nauheim, 61231
Charité Campus Mitte, Dept. of Rheumatology and Clinical Immunology
Berlin, 10117
Schlosspark-Klinik
Berlin, 14059
Praxiszentrum, St.-Bonifatius-Straße
München, 81541
United Kingdom3 sites
University of Bristol, Academic Rheumatology Unit
Bristol, BS2 8 HW
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust, Diana Princess of Wales Hospital
Lincolnshire, DN33 2BA
Arrowe Park Hospital
Metropolitan Borough of Wirral, CH49 5PE
About this study
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
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.
Read the detailed description
Study with completed results acquired from Horizon in 2024.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MR prednisone, Placebo
- Keywords
- Signs and Symptoms, Autoimmune Diseases, Joint Diseases, Arthritis, Connective Tissue Diseases, Arthritis, Rheumatoid, Rheumatic Diseases, Predniso(lo)ne
- Medical subject headings
- Arthritis, Rheumatoid, Signs and Symptoms, Autoimmune Diseases, Joint Diseases, Arthritis, Connective Tissue Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR prednisoneDrug
1 x 5 mg daily
PlaceboDrug
1x daily
| Study group | Role | What they receive |
|---|---|---|
| NP01 | Experimental | Modified Release (MR) prednisone 5 mg Receives: Drug: MR prednisone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (1)
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).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650078
- Sponsor's protocol ID
- NP01-007
- Other IDs
- EudraCT-Number: 2007-003508-36
- Acronym
- CAPRA-2
- Status last verified
- Nov 2024
- First submitted
- 28 Mar 2008
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26535146Buttgereit 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.
PubMed 22562974
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00650078
- Acronym / sponsor ID
- CAPRA-2 / NP01-007
- Conditions
- Rheumatoid Arthritis
- Keywords
- Signs and Symptoms, Autoimmune Diseases, Joint Diseases, Arthritis, Connective Tissue Diseases, Arthritis, Rheumatoid, Rheumatic Diseases, Predniso(lo)ne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Posted 13 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NP01 | Experimental | Drug: MR prednisoneModified Release (MR) prednisone 5 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR prednisone1 x 5 mg daily | Drug | NP01 |
| Placebo1x daily | Drug | Placebo |
Primary outcome
ACR 20 Response Rate at Visit 4
Time frame: Week 12
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
1 secondary outcome
Relative Reduction of Morning Stiffness
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26535146Alten 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.
- Derived from this study: PubMed 22562974Buttgereit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
52 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MR prednisone in people with Rheumatoid Arthritis, run by Amgen at 52 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Hungary, Poland, Germany, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR 20 Response Rate at Visit 4 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00650078, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.