Clinical trial NCT00794118: Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
Official title: Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility criteria: Inclusion Criteria:

1. Eighteen years of age or older
2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:

   1. Morning stiffness in and around the joints lasting at least 1 hour;
   2. Arthritis of 3 or more joint areas;
   3. Arthritis of hand joints;
   4. Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
   5. Rheumatoid nodules;
   6. Serum Rheumatoid Factor (RF)
   7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
3. Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
4. Patients naive to anti-TNF drugs
5. Outpatients

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3
timeFrame: Month 3
measure: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9
timeFrame: Month 9
measure: Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12
timeFrame: Month 12
measure: Disease Activity Score Based on 28-joints Count (DAS28) at Month 3
timeFrame: Month 3
measure: Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
timeFrame: Month 6
measure: Disease Activity Score Based on 28-joints Count (DAS28) at Month 9
timeFrame: Month 9
measure: Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
timeFrame: Month 12
measure: Patient Global Assessment (PtGA) of Disease Activity Score at Month 3
timeFrame: Month 3
measure: Patient Global Assessment (PtGA) of Disease Activity Score at Month 6
timeFrame: Month 6
measure: Patient Global Assessment (PtGA) of Disease Activity Score at Month 9
timeFrame: Month 9
measure: Patient Global Assessment (PtGA) of Disease Activity Score at Month 12
timeFrame: Month 12
measure: Physician Global Assessment (PGA) of Disease Activity at Month 3
timeFrame: Month 3
measure: Physician Global Assessment (PGA) of Disease Activity at Month 6
timeFrame: Month 6
measure: Physician Global Assessment (PGA) of Disease Activity at Month 9
timeFrame: Month 9
measure: Physician Global Assessment (PGA) of Disease Activity at Month 12
timeFrame: Month 12
measure: Visual Analogue Scale for Pain (VAS-pain) at Month 3
timeFrame: Month 3
measure: Visual Analogue Scale for Pain (VAS-pain) at Month 6
timeFrame: Month 6
measure: Visual Analogue Scale for Pain (VAS-pain) at Month 9
timeFrame: Month 9
measure: Visual Analogue Scale for Pain (VAS-pain) at Month 12
timeFrame: Month 12
measure: C-reactive Protein (CRP) at Month 3
timeFrame: Month 3
measure: C-reactive Protein (CRP) at Month 6
timeFrame: Month 6
measure: C-reactive Protein (CRP) at Month 9
timeFrame: Month 9
measure: C-reactive Protein (CRP) at Month 12
timeFrame: Month 12
measure: Erythrocyte Sedimentation Rate (ESR) at Month 3
timeFrame: Month 3
measure: Erythrocyte Sedimentation Rate (ESR) at Month 6
timeFrame: Month 6
measure: Erythrocyte Sedimentation Rate (ESR) at Month 9
timeFrame: Month 9
measure: Erythrocyte Sedimentation Rate (ESR) at Month 12
timeFrame: Month 12
measure: Number of Participants With Rheumatoid Factor (RF) at Month 3
timeFrame: Month 3
measure: Number of Participants With Rheumatoid Factor (RF) at Month 6
timeFrame: Month 6
measure: Number of Participants With Rheumatoid Factor (RF) at Month 9
timeFrame: Month 9
measure: Number of Participants With Rheumatoid Factor (RF) at Month 12
timeFrame: Month 12
measure: Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
timeFrame: Month 3
measure: Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
timeFrame: Month 6
measure: Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
timeFrame: Month 9
measure: Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
timeFrame: Month 12
measure: Number of Participants With Anti-nuclear Antibodies at Month 3
timeFrame: Month 3
measure: Number of Participants With Anti-nuclear Antibodies at Month 6
timeFrame: Month 6
measure: Number of Participants With Anti-nuclear Antibodies at Month 9
timeFrame: Month 9
measure: Number of Participants With Anti-nuclear Antibodies at Month 12
timeFrame: Month 12
measure: Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
timeFrame: Month 3
measure: Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
timeFrame: Month 6
measure: Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
timeFrame: Month 9
measure: Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
timeFrame: Month 12
measure: Duration of Morning Stiffness at Month 3
timeFrame: Month 3
measure: Duration of Morning Stiffness at Month 6
timeFrame: Month 6
measure: Duration of Morning Stiffness at Month 9
timeFrame: Month 9
measure: Duration of Morning Stiffness at Month 12
timeFrame: Month 12
measure: Stanford Health Assessment Questionnaire (HAQ) Score at Month 3
timeFrame: Month 3
measure: Stanford Health Assessment Questionnaire (HAQ) Score at Month 6
timeFrame: Month 6
measure: Stanford Health Assessment Questionnaire (HAQ) Score at Month 9
timeFrame: Month 9
measure: Stanford Health Assessment Questionnaire (HAQ) Score at Month 12
timeFrame: Month 12
measure: 36-Item Short-Form Health Survey (SF-36) at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Direct Costs
timeFrame: Baseline, Months 3, 6, 9 and 12
measure: Indirect Costs
timeFrame: Baseline, Months 3, 6, 9 and 12
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: