- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01562327
A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
18 octobre 2016 mis à jour par: Hoffmann-La Roche
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis.
Data will be collected from each eligible participant initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 months from start of treatment.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
50
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
-
-
-
Buenos Aires, Argentine, C1428DQG
-
Buenos Aires, Argentine, C1426AAL
-
Ciudad Autonoma de, Argentine, C1221ADC
-
Florencio Varela, Argentine, 1888
-
La Plata, Argentine, 1900
-
San Juan, Argentine, 5400
-
San Miguel De Tucuman, Argentine, T4000IFP
-
-
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 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
Rheumatoid arthritis participants treated with tocilizumab
La description
Inclusion Criteria:
- Adult participants, >/= 18 years of age
- Moderate to severe rheumatoid arthritis
- Participants initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including participants who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit
Exclusion Criteria:
- RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
- Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
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
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Tocilizumab
Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
|
Participants received tocilizumab according to individualized physician-prescribed regimens.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
Délai: 6 months after treatment initiation
|
6 months after treatment initiation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants With Systemic Manifestations of RA at Baseline
Délai: Baseline
|
Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease.
Participants were included if they experienced at least one of the conditions.
|
Baseline
|
Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab
Délai: Baseline
|
Baseline
|
|
Percentage of Participants Who Previously Received DMARDs
Délai: Baseline
|
Baseline
|
|
Reason for DMARDs Withdrawal at Baseline
Délai: Baseline
|
Baseline
|
|
Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab
Délai: Baseline
|
Baseline
|
|
Percentage of Participants Who Previously Received Biologic Agents
Délai: Baseline
|
Baseline
|
|
Reason for Biologic Agent Withdrawal at Baseline
Délai: Baseline
|
Baseline
|
|
Reasons for Dose Modifications
Délai: approximately 3 years
|
approximately 3 years
|
|
Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy
Délai: Approximately 3 years
|
Approximately 3 years
|
|
Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy
Délai: Baseline, Month 6
|
Percentage of participants on Tocilizumab as monotherapy or combination therapy (with DMARDs) were reported at start of treatment and at 6 months from the start of treatment.
|
Baseline, Month 6
|
Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6
Délai: Baseline, Month 3, Month 6
|
The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.
A decrease in score indicated improvement.
|
Baseline, Month 3, Month 6
|
Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6
Délai: Baseline, Month 3, Month 6
|
The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.
A decrease in score indicates improvement.
|
Baseline, Month 3, Month 6
|
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6
Délai: Month 3, Month 6
|
DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity).
DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.
|
Month 3, Month 6
|
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6
Délai: Month 3, Month 6
|
CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity.
CDAI total score = 0-76.
CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.
|
Month 3, Month 6
|
Simplified Disease Activity (SDAI) Response Classification
Délai: Month 3, Month 6
|
The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP).
SDAI total score = 0-86.
A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.
|
Month 3, Month 6
|
European League Against Rheumatism (EULAR) Response
Délai: Month 3, Month 6
|
Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point.
EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant.
The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR.
DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control.
A negative CFB indicated clinically meaningful improvement.
EULAR Good response: DAS28 <=3.2 and a CFB <-1.2.
EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2.
EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6.
|
Month 3, Month 6
|
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
Délai: Month 3, Month 6
|
ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments.
A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR).
A reduction in the level of and acute phase reactants was considered an improvement.
ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.
|
Month 3, Month 6
|
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
Délai: Baseline, Month 3, Month 6
|
The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician.
The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).
A negative change from Baseline indicated improvement.
|
Baseline, Month 3, Month 6
|
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
Délai: Baseline, Month 3, Month 6
|
The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly.
A decrease in the score indicates improvement.
|
Baseline, Month 3, Month 6
|
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)
Délai: Baseline, Month 3, Month 6
|
The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability.
It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities).
Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.
|
Baseline, Month 3, Month 6
|
Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6
Délai: Baseline, Month 3, Month 6
|
The Patient Global Assessment of fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue.
A decrease in the score indicates improvement.
|
Baseline, Month 3, Month 6
|
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
Délai: Baseline, Month 3, Month 6
|
The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain.
A decrease in the score indicates improvement.
|
Baseline, Month 3, Month 6
|
Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6
Délai: Baseline, Month 3, Month 6
|
Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities.
Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.
|
Baseline, Month 3, Month 6
|
Percentage of Participants With an Adverse Event (AE)
Délai: approximately 3 years
|
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.
|
approximately 3 years
|
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 février 2012
Achèvement primaire (Réel)
1 mars 2014
Achèvement de l'étude (Réel)
1 mars 2014
Dates d'inscription aux études
Première soumission
21 mars 2012
Première soumission répondant aux critères de contrôle qualité
22 mars 2012
Première publication (Estimation)
23 mars 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
29 novembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 octobre 2016
Dernière vérification
1 octobre 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ML28142
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 .
Essais cliniques sur Tocilizumab
-
University of ChicagoActif, ne recrute pasCOVID-19 [feminine]États-Unis
-
CelltrionPas encore de recrutement
-
Hoffmann-La RocheComplété
-
University of ChicagoRecrutement
-
Reade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and DevelopmentRecrutementLa polyarthrite rhumatoïdePays-Bas
-
Memorial Sloan Kettering Cancer CenterRésiliéCOVID-19 [feminine]États-Unis
-
University of ChicagoComplété
-
Assistance Publique - Hôpitaux de ParisInconnueInfection par corona virusFrance
-
Università Politecnica delle MarcheAzienda Ospedaliera Ospedali Riuniti Marche NordInconnue
-
Hospital of PratoInconnue