Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)

Study Overview
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Brief Summary
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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.

Official Title
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Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: As per clinical practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1.0<br>As per routinary clinical practice | Other: As per clinical practice<br>* As per clinical practice<br>* Other names: Observational study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 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 | 
| Erythrocyte Sedimentation Rate (ESR) at 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 | 
| Number of Participants With Rheumatoid Factor (RF) at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 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 | 
| Duration of Morning Stiffness at 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 | 
| Stanford Health Assessment Questionnaire (HAQ) Score at 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 | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct Costs | 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 | Indirect costs represent the loss of resources as a consequence of work disability or unemployment. | Baseline, Months 3, 6, 9 and 12 |