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

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ClinicalTrials.gov Identifier: NCT00794118
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : May 16, 2012
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 17, 2008
First Posted Date November 19, 2008
Results First Submitted Date April 12, 2012
Results First Posted Date May 16, 2012
Last Update Posted Date July 1, 2019
Study Start Date June 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2012)
  • Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 [ Time Frame: 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.
  • Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6 [ Time Frame: 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 9 [ Time Frame: 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 12 [ Time Frame: 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.
  • Disease Activity Score Based on 28-joints Count (DAS28) at Month 3 [ Time Frame: 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.
  • Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 [ Time Frame: 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 [ Time Frame: 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.
  • Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 [ Time Frame: 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 3 [ Time Frame: Month 3 ]
    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 6 [ Time Frame: Month 6 ]
    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 9 [ Time Frame: 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 [ Time Frame: 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 3 [ Time Frame: 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 6 [ Time Frame: 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.
  • Physician Global Assessment (PGA) of Disease Activity at Month 9 [ Time Frame: 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 [ Time Frame: 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 3 [ Time Frame: Month 3 ]
    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 6 [ Time Frame: Month 6 ]
    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 9 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 6 [ Time Frame: 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 [ Time Frame: Month 9 ]
    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 [ Time Frame: Month 12 ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 9 [ Time Frame: 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.
  • Number of Participants With Rheumatoid Factor (RF) at Month 12 [ Time Frame: 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-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 [ Time Frame: 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.
  • Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 3 [ Time Frame: 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 6 [ Time Frame: 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 9 [ Time Frame: 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-nuclear Antibodies at Month 12 [ Time Frame: 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 3 [ Time Frame: 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 6 [ Time Frame: 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 [ Time Frame: 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.
  • Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 [ Time Frame: 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.
  • Duration of Morning Stiffness at Month 3 [ Time Frame: 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 [ Time Frame: 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.
  • Duration of Morning Stiffness at Month 9 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 6 [ Time Frame: 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).
  • Stanford Health Assessment Questionnaire (HAQ) Score at Month 9 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
Original Primary Outcome Measures
 (submitted: November 18, 2008)
Information collected from clinical documentation at baseline and/or within 1 month of study entry, and after approximately 3, 6, 9, and 12 months. [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT00794118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 12, 2012)
  • Direct Costs [ Time Frame: 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 [ Time Frame: Baseline, Months 3, 6, 9 and 12 ]
    Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
Original Secondary Outcome Measures
 (submitted: November 18, 2008)
Cost-evaluation of different patterns of anti-TNF adoption [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
Official Title Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population primary care clinic
Condition Rheumatoid Arthritis
Intervention Other: As per clinical practice
As per clinical practice
Other Name: Observational study
Study Groups/Cohorts 1.0
As per routinary clinical practice
Intervention: Other: As per clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2011)
299
Original Estimated Enrollment
 (submitted: November 18, 2008)
500
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Exclusion Criteria:

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00794118
Other Study ID Numbers 0881A1-102321
B1801119
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019