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

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: As per clinical practice
How many people: 299 participants
Where: 1 siteItaly
Study dates: Jun 2008to Apr 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: primary care clinic

Who may be able to join

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;

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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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Pfizer Investigational Site
Roma, 00161

Other trials in Italy

About this study

Official title: Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study

Conditions: Rheumatoid Arthritis
Being tested: As per clinical practice
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

As per clinical practiceOther
Also called Observational study
As per clinical practice

Study groups in NCT00794118
Study group	Role	What they receive
1.0		As per routinary clinical practice Receives: Other: As per clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Month 12

Secondary outcomes (2)

Direct Costs
Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.
Measured: Baseline, Months 3, 6, 9 and 12
Indirect Costs
Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
Measured: Baseline, Months 3, 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Apr 2011

First posted19 Nov 2008 (estimated)
Study startJun 2008
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00794118
Sponsor's protocol ID: 0881A1-102321
Other IDs: B1801119
Acronym: DOSE
Status last verified: Jun 2019
First submitted: 17 Nov 2008
Last updated: 1 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study
ClinicalTrials.gov ID: NCT00794118
Acronym / sponsor ID: DOSE / 0881A1-102321
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 16 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1.0	–	Other: As per clinical practiceAs per routinary clinical practice

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: primary care clinic

Key inclusion criteria (12 listed)

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:
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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
As per clinical practiceAlso: Observational studyAs per clinical practice	Other	1.0

Primary outcome

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).

2 secondary outcomes

Direct Costs
Time frame: Baseline, Months 3, 6, 9 and 12
Indirect Costs
Time frame: Baseline, Months 3, 6, 9 and 12

Results and safety

Results posted to the registry on 16 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anti-tumor Necrosis Factor (Anti-TNF) Agents	299	272

Primary outcome: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3

Time frame: Month 3. Number. Unit: Percentage of participants

Measure	Anti-tumor Necrosis Factor (Anti-TNF) Agents n = 272
Value	13.4

Population analysed: Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.

Primary outcome: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6

Time frame: Month 6. Number. Unit: Percentage of participants

Measure	Anti-tumor Necrosis Factor (Anti-TNF) Agents n = 272
Value	21.6

Population analysed: ITT population included all participants who received at least 1 dose of the study medication.

Primary outcome: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9

Time frame: Month 9. Number. Unit: Percentage of participants

Measure	Anti-tumor Necrosis Factor (Anti-TNF) Agents n = 272
Value	27.2

Population analysed: ITT population included all participants who received at least 1 dose of the study medication.

Primary outcome: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12

Time frame: Month 12. Number. Unit: Percentage of participants

Measure	Anti-tumor Necrosis Factor (Anti-TNF) Agents n = 272
Value	22.6

Population analysed: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anti-tumor Necrosis Factor (Anti-TNF) Agents	0 of 272 (0%)	21 of 272 (7.7%)	Not reported

Limitations and caveats (from the sponsor): Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 (time frame: Month 3). The study lists 53 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00794118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.