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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 11, 2014