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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00794118
First received: November 17, 2008
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Other: As per clinical practice

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Direct Costs [ Time Frame: Baseline, Months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Indirect costs represent the loss of resources as a consequence of work disability or unemployment.


Enrollment: 299
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1.0
As per routinary clinical practice
Other: As per clinical practice
As per clinical practice
Other Name: Observational study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794118

Locations
Italy
Pfizer Investigational Site
Roma, Italy, 00161
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00794118     History of Changes
Other Study ID Numbers: 0881A1-102321, B1801119
Study First Received: November 17, 2008
Results First Received: April 12, 2012
Last Updated: April 12, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014