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The purpose of this study is to find patterns in the use of non-biological DMARDs as the initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may impact therapeutic decisions in real life in the Spanish Andalusian region.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question | 6 years | |
| Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with rheumatoid arthritis.
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| Name | Affiliation | Role |
|---|---|---|
| Federico Navarro, Dr. | Fundacion Andaluza de Reumatologia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina Sofía | Córdoba | Andalusia | Spain | |||
| Consulta privada Dr. Rafael Cáliz |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Whom Fulfilled the ACR | Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 years |
| Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment | 6 years |
| Percentage of Patients Who Receive Subcutaneous Methotrexate | 6 years |
| Exposure Time of Methotrexate | methotrexate | 6 years |
| Granada |
| Andalusia |
| 18014 |
| Spain |
| Hospital San Cecilio | Granada | Andalusia | Spain |
| Hospital Virgen de las Nieves | Granada | Andalusia | Spain |
| Hospital Quirón Málaga | Málaga | Andalusia | 29004 | Spain |
| Clinica Xanit | Málaga | Andalusia | 29630 | Spain |
| Consulta Dra. Belmonte | Málaga | Andalusia | Spain |
| Hospital Carlos Haya | Málaga | Andalusia | Spain |
| Hospital Virgen Macarena | Seville | Andalusia | 41071 | Spain |
| Hospital Virgen del Rocío | Seville | Andalusia | Spain |
| Hospital Comarcal de Melilla | Melilla | Melilla | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Whom Fulfilled the ACR | Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice | Posted | Number | 95% Confidence Interval | percentage of participants | 6 years |
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| Secondary | Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question | Posted | Number | 95% Confidence Interval | percentage of participants | 6 years |
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| Secondary | Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal | Posted | Number | 95% Confidence Interval | percentage of participants | 6 years |
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| Secondary | Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment | Posted | Number | 95% Confidence Interval | percentage of participants | 6 years |
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| Secondary | Percentage of Patients Who Receive Subcutaneous Methotrexate | Posted | Number | 95% Confidence Interval | percentage of participants | 6 years |
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| Secondary | Exposure Time of Methotrexate | methotrexate | Posted | Mean | Standard Deviation | months | 6 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Whom Fulfilled the ACR | Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period. | 0 | 301 | 0 | 301 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Federico Navarro Sarabia | Hospital Virgen de la Macarena | +34 955 00 80 00 | federico.navarro.sarabia@gmail.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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