Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose) (DOSE)
20. juni 2019 oppdatert av: 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.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
299
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Roma, Italia, 00161
- Pfizer Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
primary care clinic
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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1.0
As per routinary clinical practice
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As per clinical practice
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Erythrocyte Sedimentation Rate (ESR) at Month 6
Tidsramme: 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
Tidsramme: 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
|
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Duration of Morning Stiffness at Month 6
Tidsramme: 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.
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Month 6
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Duration of Morning Stiffness at Month 12
Tidsramme: Month 12
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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.
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Month 12
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Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3
Tidsramme: 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.
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Month 3
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Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6
Tidsramme: 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.
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Month 6
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Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9
Tidsramme: 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.
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Month 9
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Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12
Tidsramme: 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.
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Month 12
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Disease Activity Score Based on 28-joints Count (DAS28) at Month 3
Tidsramme: 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.
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Month 3
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Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Tidsramme: 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.
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Month 6
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Disease Activity Score Based on 28-joints Count (DAS28) at Month 9
Tidsramme: 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.
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Month 9
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Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
Tidsramme: 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.
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Month 12
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Patient Global Assessment (PtGA) of Disease Activity Score at Month 3
Tidsramme: Month 3
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PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
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Month 3
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Patient Global Assessment (PtGA) of Disease Activity Score at Month 6
Tidsramme: Month 6
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PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
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Month 6
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Patient Global Assessment (PtGA) of Disease Activity Score at Month 9
Tidsramme: Month 9
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
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Month 9
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Patient Global Assessment (PtGA) of Disease Activity Score at Month 12
Tidsramme: Month 12
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PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
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Month 12
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Physician Global Assessment (PGA) of Disease Activity at Month 3
Tidsramme: Month 3
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PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
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Month 3
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Physician Global Assessment (PGA) of Disease Activity at Month 6
Tidsramme: Month 6
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PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
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Month 6
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Physician Global Assessment (PGA) of Disease Activity at Month 9
Tidsramme: Month 9
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PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
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Month 9
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Physician Global Assessment (PGA) of Disease Activity at Month 12
Tidsramme: 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.
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Month 12
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Visual Analogue Scale for Pain (VAS-pain) at Month 3
Tidsramme: Month 3
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
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Month 3
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Visual Analogue Scale for Pain (VAS-pain) at Month 6
Tidsramme: Month 6
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
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Month 6
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Visual Analogue Scale for Pain (VAS-pain) at Month 9
Tidsramme: Month 9
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
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Month 9
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Visual Analogue Scale for Pain (VAS-pain) at Month 12
Tidsramme: Month 12
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
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Month 12
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C-reactive Protein (CRP) at Month 3
Tidsramme: Month 3
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CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
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Month 3
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C-reactive Protein (CRP) at Month 6
Tidsramme: Month 6
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 6
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C-reactive Protein (CRP) at Month 9
Tidsramme: Month 9
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 9
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C-reactive Protein (CRP) at Month 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Number of Participants With Rheumatoid Factor (RF) at Month 3
Tidsramme: 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.
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Month 3
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Number of Participants With Rheumatoid Factor (RF) at Month 6
Tidsramme: Month 6
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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.
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Month 6
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Number of Participants With Rheumatoid Factor (RF) at Month 9
Tidsramme: 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.
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Month 9
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Number of Participants With Rheumatoid Factor (RF) at Month 12
Tidsramme: 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.
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Month 12
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Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
Tidsramme: 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.
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Month 3
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Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
Tidsramme: 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
|
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Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
Tidsramme: 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.
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Month 9
|
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
Tidsramme: 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
|
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Number of Participants With Anti-nuclear Antibodies at Month 3
Tidsramme: 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.
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Month 3
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Number of Participants With Anti-nuclear Antibodies at Month 6
Tidsramme: 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.
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Month 6
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Number of Participants With Anti-nuclear Antibodies at Month 9
Tidsramme: 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.
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Month 9
|
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Number of Participants With Anti-nuclear Antibodies at Month 12
Tidsramme: 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.
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Month 12
|
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Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
Tidsramme: 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.
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Month 3
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Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
Tidsramme: 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
|
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Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
Tidsramme: 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
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Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
Tidsramme: 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
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|
Duration of Morning Stiffness at Month 3
Tidsramme: 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
Tidsramme: 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
|
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Stanford Health Assessment Questionnaire (HAQ) Score at Month 3
Tidsramme: 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).
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Month 3
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Stanford Health Assessment Questionnaire (HAQ) Score at Month 6
Tidsramme: 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).
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Month 6
|
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 9
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
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Month 12
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Direct Costs
Tidsramme: 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.
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Baseline, Months 3, 6, 9 and 12
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Indirect Costs
Tidsramme: Baseline, Months 3, 6, 9 and 12
|
Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
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Baseline, Months 3, 6, 9 and 12
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2008
Primær fullføring (Faktiske)
1. april 2011
Studiet fullført (Faktiske)
1. april 2011
Datoer for studieregistrering
Først innsendt
17. november 2008
Først innsendt som oppfylte QC-kriteriene
18. november 2008
Først lagt ut (Anslag)
19. november 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juli 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juni 2019
Sist bekreftet
1. juni 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0881A1-102321
- B1801119
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