Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose) (DOSE)
20 juin 2019 mis à jour par: Pfizer
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study
The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients.
Data will be collected only from subjects providing informed consent.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
299
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
-
-
-
Roma, Italie, 00161
- Pfizer Investigational 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 et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
primary care clinic
La description
Inclusion Criteria:
- Eighteen years of age or older
Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:
- Morning stiffness in and around the joints lasting at least 1 hour;
- Arthritis of 3 or more joint areas;
- Arthritis of hand joints;
- Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
- Rheumatoid nodules;
- Serum Rheumatoid Factor (RF)
- Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
- Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
- Patients naive to anti-TNF drugs
- Outpatients
Exclusion Criteria:
Patients involved in controlled or interventional trials in the 12 previous 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
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
1.0
As per routinary clinical practice
|
As per clinical practice
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Month 6
Délai: Month 6
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 6
|
|
Erythrocyte Sedimentation Rate (ESR) at Month 12
Délai: Month 12
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 12
|
|
Duration of Morning Stiffness at Month 6
Délai: Month 6
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 6
|
|
Duration of Morning Stiffness at Month 12
Délai: Month 12
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 12
|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3
Délai: Month 3
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.
|
Month 3
|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6
Délai: Month 6
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 <2.6.
|
Month 6
|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9
Délai: Month 9
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 <2.6.
|
Month 9
|
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12
Délai: Month 12
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 < 2.6.
|
Month 12
|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 3
Délai: Month 3
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 3
|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Délai: Month 6
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 6
|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 9
Délai: Month 9
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 9
|
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
Délai: Month 12
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 12
|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 3
Délai: Month 3
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 3
|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 6
Délai: Month 6
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 6
|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 9
Délai: Month 9
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 9
|
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 12
Délai: Month 12
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 12
|
|
Physician Global Assessment (PGA) of Disease Activity at Month 3
Délai: Month 3
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 3
|
|
Physician Global Assessment (PGA) of Disease Activity at Month 6
Délai: Month 6
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 6
|
|
Physician Global Assessment (PGA) of Disease Activity at Month 9
Délai: Month 9
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 9
|
|
Physician Global Assessment (PGA) of Disease Activity at Month 12
Délai: Month 12
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 12
|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 3
Délai: Month 3
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 3
|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 6
Délai: Month 6
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 6
|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 9
Délai: Month 9
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 9
|
|
Visual Analogue Scale for Pain (VAS-pain) at Month 12
Délai: Month 12
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 12
|
|
C-reactive Protein (CRP) at Month 3
Délai: Month 3
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 3
|
|
C-reactive Protein (CRP) at Month 6
Délai: Month 6
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 6
|
|
C-reactive Protein (CRP) at Month 9
Délai: Month 9
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 9
|
|
C-reactive Protein (CRP) at Month 12
Délai: Month 12
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 12
|
|
Erythrocyte Sedimentation Rate (ESR) at Month 3
Délai: Month 3
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 3
|
|
Erythrocyte Sedimentation Rate (ESR) at Month 9
Délai: Month 9
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 9
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 3
Délai: Month 3
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 3
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 6
Délai: Month 6
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 6
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 9
Délai: Month 9
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 9
|
|
Number of Participants With Rheumatoid Factor (RF) at Month 12
Délai: Month 12
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 12
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
Délai: Month 3
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 3
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
Délai: Month 6
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 6
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
Délai: Month 9
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 9
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
Délai: Month 12
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 12
|
|
Number of Participants With Anti-nuclear Antibodies at Month 3
Délai: Month 3
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 3
|
|
Number of Participants With Anti-nuclear Antibodies at Month 6
Délai: Month 6
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 6
|
|
Number of Participants With Anti-nuclear Antibodies at Month 9
Délai: Month 9
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 9
|
|
Number of Participants With Anti-nuclear Antibodies at Month 12
Délai: Month 12
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 12
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
Délai: Month 3
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 3
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
Délai: Month 6
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 6
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
Délai: Month 9
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 9
|
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
Délai: Month 12
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 12
|
|
Duration of Morning Stiffness at Month 3
Délai: Month 3
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 3
|
|
Duration of Morning Stiffness at Month 9
Délai: Month 9
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 9
|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 3
Délai: Month 3
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 3
|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 6
Délai: Month 6
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 6
|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 9
Délai: Month 9
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 9
|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 12
Délai: Month 12
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 12
|
|
36-Item Short-Form Health Survey (SF-36) at Month 12
Délai: Month 12
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
|
Month 12
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Direct Costs
Délai: Baseline, Months 3, 6, 9 and 12
|
Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.
|
Baseline, Months 3, 6, 9 and 12
|
|
Indirect Costs
Délai: Baseline, Months 3, 6, 9 and 12
|
Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
|
Baseline, Months 3, 6, 9 and 12
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Publications et liens utiles
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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 juin 2008
Achèvement primaire (Réel)
1 avril 2011
Achèvement de l'étude (Réel)
1 avril 2011
Dates d'inscription aux études
Première soumission
17 novembre 2008
Première soumission répondant aux critères de contrôle qualité
18 novembre 2008
Première publication (Estimation)
19 novembre 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juillet 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0881A1-102321
- B1801119
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 .