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

NCT00794118 | Completed Results DMC

• 2 other identifiers: 0881A1-102321B1801119
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (53)

• 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 Outcomes (2)

• Direct Costs

  Baseline, Months 3, 6, 9 and 12

• Indirect Costs

  Baseline, Months 3, 6, 9 and 12

Study Arms (1)

1.0

As per routinary clinical practice

Other: As per clinical practice

Interventions

As per clinical practice OTHER

As per clinical practice

Also known as: Observational study

1.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Roma, 00161, Italy

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Observation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Limitations and Caveats

Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 1, 2019
• Results First Posted: May 16, 2012

Record last verified: 2019-06

Locations

IT (1)