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- Essai clinique NCT01592292
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
6 juillet 2016 mis à jour par: Hoffmann-La Roche
A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy.
Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy.
Data will be collected for 12 months.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
90
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
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Busan, Corée, République de, 48108
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Daegu, Corée, République de, 41931
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Daegu, Corée, République de, 42472
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Daejeon, Corée, République de, 302-799
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Gwangju, Corée, République de, 61469
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Gyeonggi-do, Corée, République de, 10380
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Jeju Special Self-Governing Province, Corée, République de, 63241
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Jeollabuk-do, Corée, République de, 561-712
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Seoul, Corée, République de, 150-713
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Seoul, Corée, République de, 130-702
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Seoul, Corée, République de, 05030
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Seoul, Corée, République de, 06273
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Seoul, Corée, République de, 134-722
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Suwon, Corée, République de, 442-723
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Ulsan, Corée, République de, 44033
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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
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.
La description
Inclusion Criteria:
- Adult participants, >/=20 years of age
- Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy
Exclusion Criteria:
- Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
- Participants who have not signed the informed consent form
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
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
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Rituximab as per physician's discretion.
Autres noms:
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Other anti-TNF agent
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.
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Adalimumab as per physician's discretion.
Etanercept as per physician's discretion.
Infliximab as per physician's discretion.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
Délai: Baseline and Month 6
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
Délai: Baseline and Month 6
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Efficacy: Mean Change From Baseline in DAS28 at Month 12
Délai: Baseline and Month 12
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Délai: Baseline, Month 6 and 12
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TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Délai: Baseline, Month 6 and 12
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TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Délai: Baseline, Month 6 and 12
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SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Délai: Baseline, Month 6 and 12
|
SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Délai: Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Délai: Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Délai: Baseline, Month 6 and 12
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CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Délai: Baseline, Month 6 and 12
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CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
Délai: Month 6
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The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
Délai: Month 6
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The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
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Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Délai: Baseline up to Month 12
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
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Baseline up to Month 12
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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
1 novembre 2011
Achèvement primaire (Réel)
1 décembre 2014
Achèvement de l'étude (Réel)
1 décembre 2014
Dates d'inscription aux études
Première soumission
11 avril 2012
Première soumission répondant aux critères de contrôle qualité
3 mai 2012
Première publication (Estimation)
7 mai 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
22 août 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2016
Dernière vérification
1 mars 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies auto-immunes
- Maladies articulaires
- Maladies musculo-squelettiques
- Maladies rhumatismales
- Maladies du tissu conjonctif
- Arthrite
- Arthrite, rhumatoïde
- Effets physiologiques des médicaments
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Agents anti-inflammatoires non stéroïdiens
- Analgésiques, non narcotiques
- Agents anti-inflammatoires
- Agents antirhumatismaux
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents gastro-intestinaux
- Agents antinéoplasiques immunologiques
- Agents dermatologiques
- Étanercept
- Adalimumab
- Rituximab
- Infliximab
Autres numéros d'identification d'étude
- ML27923
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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