Rheumatoid Arthritis Clinical Trial
— SAR-FAMEOfficial title:
A Retrospective, Multicentre Observational Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Real Life in Patients With Rheumatoid Arthritis
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.
Status | Completed |
Enrollment | 301 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients of both sexes = 18 years. - Patients diagnosed with RA (according to the American College of Rheumatology (ACR) 2010 criteria) between January 2008 and December 2012 and who have initiated treatment with at least one synthetic DMARD during that period. - Patients who have given written informed consent for their data to be collected and reviewed. Exclusion Criteria: - Patients who are already participating in a clinical trial/s at the moment of participation in this study. - Patients with whom it is suspected there will be insufficient information to complete the study objectives. |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Reina Sofía | Cordoba | Andalucia |
Spain | Consulta privada Dr. Rafael Cáliz | Granada | Andalucía |
Spain | Hospital San Cecilio | Granada | Andalucia |
Spain | Hospital Virgen de las Nieves | Granada | Andalucia |
Spain | Consulta Dra. Belmonte | Malaga | Andalucia |
Spain | Hospital Carlos Haya | Malaga | Andalucia |
Spain | Clinica Xanit | Málaga | Andalucía |
Spain | Hospital Quirón Málaga | Málaga | Andalucía |
Spain | Hospital Comarcal de Melilla | Melilla | |
Spain | Hospital Virgen del Rocío | Sevilla | Andalucia |
Spain | Hospital Virgen Macarena | Sevilla | Andalucía |
Spain | Hospital Virgen Macarena | Sevilla | Andalucia |
Lead Sponsor | Collaborator |
---|---|
Fundación Andaluza de Reumatología |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 6 years | No | |
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 | 6 years | No | |
Secondary | Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal | 6 years | No | |
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 | 6 years | No | |
Secondary | Percentage of Patients Who Receive Subcutaneous Methotrexate | 6 years | No | |
Secondary | Exposure Time of Methotrexate | methotrexate | 6 years | No |
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