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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: As per clinical practice

• Registration Number: NCT00794118
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-04-12
• Results First Submitted QC: 2012-04-12
• Results First Posted: 2012-05-16
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

1. Eighteen years of age or older

2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:

   1. Morning stiffness in and around the joints lasting at least 1 hour;
   2. Arthritis of 3 or more joint areas;
   3. Arthritis of hand joints;
   4. Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
   5. Rheumatoid nodules;
   6. Serum Rheumatoid Factor (RF)
   7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.

3. Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology

4. Patients naive to anti-TNF drugs

5. Outpatients

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Exclusion Criteria

Patients involved in controlled or interventional trials in the 12 previous months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1.0	As per clinical practice	As per routinary clinical practice

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6	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.
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12	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.
Patient Global Assessment (PtGA) of Disease Activity Score at Month 9	Month 9	PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Patient Global Assessment (PtGA) of Disease Activity Score at Month 12	Month 12	PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Physician Global Assessment (PGA) of Disease Activity at Month 6	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.
Visual Analogue Scale for Pain (VAS-pain) at Month 6	Month 6	10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9	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.
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3	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.
Disease Activity Score Based on 28-joints Count (DAS28) at Month 12	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.
Patient Global Assessment (PtGA) of Disease Activity Score at Month 6	Month 6	PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Visual Analogue Scale for Pain (VAS-pain) at Month 3	Month 3	10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Number of Participants With Rheumatoid Factor (RF) at Month 9	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.
Disease Activity Score Based on 28-joints Count (DAS28) at Month 3	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.
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3	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.
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6	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.
Disease Activity Score Based on 28-joints Count (DAS28) at Month 9	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.
Patient Global Assessment (PtGA) of Disease Activity Score at Month 3	Month 3	PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Physician Global Assessment (PGA) of Disease Activity at Month 3	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.
Physician Global Assessment (PGA) of Disease Activity at Month 9	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.
Physician Global Assessment (PGA) of Disease Activity at Month 12	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.
Visual Analogue Scale for Pain (VAS-pain) at Month 9	Month 9	10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Visual Analogue Scale for Pain (VAS-pain) at Month 12	Month 12	10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
C-reactive Protein (CRP) at Month 3	Month 3	CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
C-reactive Protein (CRP) at Month 12	Month 12	CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
C-reactive Protein (CRP) at Month 6	Month 6	CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
C-reactive Protein (CRP) at Month 9	Month 9	CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Erythrocyte Sedimentation Rate (ESR) at Month 3	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.
Erythrocyte Sedimentation Rate (ESR) at Month 6	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.
Erythrocyte Sedimentation Rate (ESR) at Month 9	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.
Erythrocyte Sedimentation Rate (ESR) at Month 12	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.
Number of Participants With Rheumatoid Factor (RF) at Month 3	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.
Number of Participants With Rheumatoid Factor (RF) at Month 6	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.
Number of Participants With Rheumatoid Factor (RF) at Month 12	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.
Number of Participants With Anti-nuclear Antibodies at Month 3	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.
Number of Participants With Anti-nuclear Antibodies at Month 9	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.
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3	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.
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12	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.
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6	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.
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9	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.
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12	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.
Number of Participants With Anti-nuclear Antibodies at Month 6	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.
Number of Participants With Anti-nuclear Antibodies at Month 12	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.
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6	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.
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9	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.
Duration of Morning Stiffness at Month 3	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.
Duration of Morning Stiffness at Month 6	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.
Stanford Health Assessment Questionnaire (HAQ) Score at Month 6	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).
Duration of Morning Stiffness at Month 9	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.
Duration of Morning Stiffness at Month 12	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.
Stanford Health Assessment Questionnaire (HAQ) Score at Month 3	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).
Stanford Health Assessment Questionnaire (HAQ) Score at Month 9	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).
Stanford Health Assessment Questionnaire (HAQ) Score at Month 12	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).
36-Item Short-Form Health Survey (SF-36) at Month 12	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).

Secondary Outcome Measures

Name	Time	Method
Direct Costs	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.
Indirect Costs	Baseline, Months 3, 6, 9 and 12	Indirect costs represent the loss of resources as a consequence of work disability or unemployment.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇹 Roma, Italy