Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Rheumatoid Arthritis (RA)

NCT ID: NCT02094326

Last Updated: 2016-03-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Andaluza de Reumatología

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federico Navarro, Dr.

Role: STUDY_DIRECTOR

Fundacion Andaluza de Reumatologia

Locations

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Hospital Reina Sofía

Córdoba, Andalusia, Spain

Site Status

Consulta privada Dr. Rafael Cáliz

Granada, Andalusia, Spain

Site Status

Hospital San Cecilio

Granada, Andalusia, Spain

Site Status

Hospital Virgen de las Nieves

Granada, Andalusia, Spain

Site Status

Hospital Quirón Málaga

Málaga, Andalusia, Spain

Site Status

Clinica Xanit

Málaga, Andalusia, Spain

Site Status

Consulta Dra. Belmonte

Málaga, Andalusia, Spain

Site Status

Hospital Carlos Haya

Málaga, Andalusia, Spain

Site Status

Hospital Virgen Macarena

Seville, Andalusia, Spain

Site Status

Hospital Virgen del Rocío

Seville, Andalusia, Spain

Site Status

Hospital Comarcal de Melilla

Melilla, Melilla, Spain

Site Status

Countries

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Spain

Other Identifiers

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SAR-FAM-2013-01

Identifier Type: -

Identifier Source: org_study_id

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