- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00146640
Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
4. juni 2018 opdateret af: Merck KGaA, Darmstadt, Germany
A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only
The objective of this study is to investigate if low doses of prednisone MR formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone given in the morning.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
288
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bialystok, Polen
- Research Site
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Katowice, Polen
- Research Site
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Kraków, Polen
- Research Site
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Lublin, Polen
- Research Site
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Poznan, Polen
- Research Site
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Sopot, Polen
- Research Site
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Torun, Polen
- Research Site
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Warszawa, Polen
- Research Site
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Wroclaw, Polen
- Research Site
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Aachen, Tyskland
- Research Site
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Bad Kreuznach, Tyskland
- Research Site
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Berlin, Tyskland
- Research Site
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Dresden, Tyskland
- Research Site
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Düsseldorf, Tyskland
- Research Site
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Erlangen, Tyskland
- Research Site
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Frankfurt/Main, Tyskland
- Research Site
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Hamburg, Tyskland
- Research Site
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Hannover, Tyskland
- Research Site
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Jena, Tyskland
- Research Site
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Köln, Tyskland
- Research Site
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Leipzig, Tyskland
- Research Site
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München, Tyskland
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Ratingen, Tyskland
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Rostock, Tyskland
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Active disease (inflammatory signs, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP])
- Stable condition
- Stable basic treatments
- Morning stiffness on previous treatment with standard prednisone (below or equal to 10 mg per day) greater than or equal to (>/=) 45 minutes
Exclusion Criteria:
- All contra-indications for glucocorticoids
- Pregnancy
- Concomitant treatment with biologics
- Intra-articular injections or synovectomy within the previous 4 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: MR Prednisone
Participants will receive MR prednisone at bed time and placebo matching to IR prednisone in the morning.
Total duration of double blind treatment will be 12 weeks.
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Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams [mg] prednisone per day) at bed time.
Participants will receive placebo matching to IR prednisone tablet in the morning.
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Aktiv komparator: IR Prednisone
Participants will receive IR prednisone in the morning and placebo matching to MR prednisone at bed time.
Total duration of double blind treatment will be 12 weeks.
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Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
Participants will receive placebo matching to MR prednisone tablet at bed time.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Relative Change From Baseline in Duration of Morning Stiffness at Week 12
Tidsramme: Baseline, Week 12
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Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness.
Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.
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Baseline, Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12
Tidsramme: Baseline, Week 12
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DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
Total DAS28 score range from 0 to approximately 10. DAS28 less than or equal to (≤) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity, and DAS28 >5.1 = severe disease activity.
Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.
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Baseline, Week 12
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Percentage of Participants With Recurrence of Joint Stiffness at Week 12
Tidsramme: Week 12
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Participants recorded the status of recurrence of joint stiffness (Yes/No) in diary data.
Percentage of participants who selected Yes for recurrence of joint stiffness, are reported.
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Week 12
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Relative Change From Baseline in Pain Intensity at Week 12
Tidsramme: Baseline, Week 12
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Participants assessed pain intensity on a 100 millimeter (mm) visual analog scale (VAS), where 0 mm = no pain, 100 mm = worst pain.
Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.
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Baseline, Week 12
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Relative Change From Baseline in Quality of Sleep at Week 12
Tidsramme: Baseline, Week 12
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Participants assessed quality of sleep on a 100 mm VAS, where 0 mm = very good, 100 mm = very bad.
Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.
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Baseline, Week 12
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Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Tidsramme: Baseline, Week 12
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.
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Baseline, Week 12
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Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12
Tidsramme: Baseline, Week 12
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SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health.
The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning).
Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS.
Total score range for MCS was 0-100 (100=highest level of mental functioning).
Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.
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Baseline, Week 12
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Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12
Tidsramme: Baseline, Week 12
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SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health.
The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning).
Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS.
Total score range for PCS was 0-100 (100=highest level of physical functioning).
Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.
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Baseline, Week 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Alten R, Doring G, Cutolo M, Gromnica-Ihle E, Witte S, Straub R, Buttgereit F. Hypothalamus-pituitary-adrenal axis function in patients with rheumatoid arthritis treated with nighttime-release prednisone. J Rheumatol. 2010 Oct;37(10):2025-31. doi: 10.3899/jrheum.100051. Epub 2010 Aug 3.
- Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, Jeka S, Krueger K, Szechinski J, Alten R. Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomised controlled trial. Lancet. 2008 Jan 19;371(9608):205-14. doi: 10.1016/S0140-6736(08)60132-4.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
31. august 2004
Primær færdiggørelse (Faktiske)
31. januar 2007
Studieafslutning (Faktiske)
31. januar 2007
Datoer for studieregistrering
Først indsendt
6. september 2005
Først indsendt, der opfyldte QC-kriterier
6. september 2005
Først opslået (Skøn)
7. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Ledsygdomme
- Muskuloskeletale sygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Gigt
- Gigt, reumatoid
- Lægemidlers fysiologiske virkninger
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Prednison
Andre undersøgelses-id-numre
- EMR 62215-003
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Rheumatoid arthritis
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Janssen Research & Development, LLCTrukket tilbageAktiv reumatoid arthritis; Rheumatoid arthritis
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Hamad Medical CorporationUkendtRHEUMATOID ARTHRITISQatar
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Richard Burt, MDAfsluttet
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Healthcare Homoeo Charitable SocietyUkendtRheumatoid arthritis.Indien
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Federal University of São PauloAfsluttetRheumatoid arthritis.Brasilien
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Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUkendt- Rheumatoid arthritisBrasilien
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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Biomet Orthopedics, LLCNew Lexington ClinicAfsluttetSlidgigt | Rheumatoid arthritis | Knæ arthritis | Degenerativ arthritisForenede Stater
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University of SalfordAfsluttetRheumatoid arthritis | Håndslidgigt | Inflammatorisk arthritisDet Forenede Kongerige
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Link America, Inc.AfsluttetSlidgigt | Rheumatoid arthritis | Post-traumatisk arthritisForenede Stater
Kliniske forsøg med MR Prednisone
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Horizon Pharma Ireland, Ltd., Dublin IrelandAfsluttetRheumatoid arthritisForenede Stater, Tyskland, Ungarn, Canada, Polen, Det Forenede Kongerige
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Oregon Health and Science UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Afsluttet
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University of ZurichBalgrist University HospitalIkke rekrutterer endnu
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Assistance Publique Hopitaux De MarseilleAktiv, ikke rekrutterende
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National Institute of Diabetes and Digestive and...RekrutteringSund og rask | Fedme | Diabetes | Åreforkalkning | Sunde frivilligeForenede Stater
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Memorial Sloan Kettering Cancer CenterAfsluttet
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Washington University School of MedicineAfsluttetKræft | Ondartet tumorForenede Stater
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M.D. Anderson Cancer CenterAfsluttet
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Tel-Aviv Sourasky Medical CenterUkendtCat-ridse sygdom | Bartonella infektionerIsrael
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Bragee ClinicsIkke rekrutterer endnuKronisk træthedssyndrom