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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 juin 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

288

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Aachen, Allemagne
        • Research Site
      • Bad Kreuznach, Allemagne
        • Research Site
      • Berlin, Allemagne
        • Research Site
      • Dresden, Allemagne
        • Research Site
      • Düsseldorf, Allemagne
        • Research Site
      • Erlangen, Allemagne
        • Research Site
      • Frankfurt/Main, Allemagne
        • Research Site
      • Hamburg, Allemagne
        • Research Site
      • Hannover, Allemagne
        • Research Site
      • Jena, Allemagne
        • Research Site
      • Köln, Allemagne
        • Research Site
      • Leipzig, Allemagne
        • Research Site
      • München, Allemagne
        • Research Site
      • Ratingen, Allemagne
        • Research Site
      • Rostock, Allemagne
        • Research Site
  • Pologne
      • Bialystok, Pologne
        • Research Site
      • Katowice, Pologne
        • Research Site
      • Kraków, Pologne
        • Research Site
      • Lublin, Pologne
        • Research Site
      • Poznan, Pologne
        • Research Site
      • Sopot, Pologne
        • Research Site
      • Torun, Pologne
        • Research Site
      • Warszawa, Pologne
        • Research Site
      • Wroclaw, Pologne
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: MR Prednisone
Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams [mg] prednisone per day) at bed time.
Médicament: Placebo - IR Prednisone
Participants will receive placebo matching to IR prednisone tablet in the morning.
Comparateur actif: 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.
Médicament: IR Prednisone
Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
Médicament: Placebo - MR Prednisone
Participants will receive placebo matching to MR prednisone tablet at bed time.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Relative Change From Baseline in Duration of Morning Stiffness at Week 12
Délai: Baseline, Week 12
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.
Baseline, Week 12

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12
Délai: Baseline, Week 12
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.
Baseline, Week 12
Percentage of Participants With Recurrence of Joint Stiffness at Week 12
Délai: Week 12
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.
Week 12
Relative Change From Baseline in Pain Intensity at Week 12
Délai: Baseline, Week 12
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.
Baseline, Week 12
Relative Change From Baseline in Quality of Sleep at Week 12
Délai: Baseline, Week 12
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.
Baseline, Week 12
Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Délai: Baseline, Week 12
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.
Baseline, Week 12
Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12
Délai: Baseline, Week 12
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.
Baseline, Week 12
Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12
Délai: Baseline, Week 12
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.
Baseline, Week 12

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Merck KGaA, Darmstadt, Germany

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 août 2004

Achèvement primaire (Réel)

31 janvier 2007

Achèvement de l'étude (Réel)

31 janvier 2007

Dates d'inscription aux études

Première soumission

6 septembre 2005

Première soumission répondant aux critères de contrôle qualité

6 septembre 2005

Première publication (Estimation)

7 septembre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juillet 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2018

Dernière vérification

1 juin 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • EMR 62215-003

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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