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| ID | Type | Description | Link |
|---|---|---|---|
| B1801108 |
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This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. The observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. The primary goal is to define prevalence of clinical remission, according to the (Disease Activity Score) DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Secondary objective are assessment of:
It was expected that approximate 200 patients were enrolled in the study. Have been enrolled 152 patients. A Statistical Analysis Plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses. In general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study. The summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 | As per routinary clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| as clinical practice | Other | Dosage, form, frequency and duration as per ordinary clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year. | 12-24 months |
| Measure | Description | Time Frame |
|---|---|---|
| -Prevalence of Remission at the second year. | 12-24 months | |
| Disease activity at the 1st and 2nd year | 12-24 months | |
| ACR 20%, 50%, 70% response at the 1st and 2nd year |
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Inclusion Criteria:
Inclusion Criteria Based On Clinical Practice of Aggressive RA
Exclusion Criteria:
Exclusion Criteria Based on Clinical Practice of Aggressive RA
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Patients with early aggressive RA, who are treated in 15 specialized sites
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Iesi | Ancona | 60035 | Italy | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D019370 | Observation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| 12-24 months |
| QoL in patients with or without remission at the first and second year | 12-24 months |
| Safety Evaluations | 12-24 months |
| Bari |
| Apulia |
| 70124 |
| Italy |
| Pfizer Investigational Site | Naples | Campania | 80131 | Italy |
| Pfizer Investigational Site | Ferrara | Ferrara (FE) | 44100 | Italy |
| Pfizer Investigational Site | Arenzano | GE | 16011 | Italy |
| Pfizer Investigational Site | Rome | Lazio | 00161 | Italy |
| Pfizer Investigational Site | Messina | Messina | 98122 | Italy |
| Pfizer Investigational Site | Padova | Padova | 35128 | Italy |
| Pfizer Investigational Site | Palermo | Palermo | 90100 | Italy |
| Pfizer Investigational Site | Messina | Sicily | 98127 | Italy |
| Pfizer Investigational Site | Siena | Siena | 53100 | Italy |
| Pfizer Investigational Site | Pisa | Tuscany | 56126 | Italy |
| Pfizer Investigational Site | Brescia | 25125 | Italy |
| Pfizer Investigational Site | Genova | Italy |
| Pfizer Investigational Site | Pavia | 27100 | Italy |
| Pfizer Investigational Site | Torino | 10128 | Italy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D008722 | Methods |
| D008919 | Investigative Techniques |