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)

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02094326
• Lead Sponsor: Fundación Andaluza de Reumatología

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-01-12
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-09
• Last Update Submitted: 2016-02-09
• Results First Posted: 2016-03-08
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Receive Subcutaneous Methotrexate	6 years
Exposure Time of Methotrexate	6 years	methotrexate
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	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

Trial Locations

Locations (11)

Hospital Virgen de las Nieves; 🇪🇸 Granada, Andalucia, Spain

Hospital San Cecilio; 🇪🇸 Granada, Andalucia, Spain

Hospital Reina Sofía; 🇪🇸 Cordoba, Andalucia, Spain

Consulta Dra. Belmonte; 🇪🇸 Malaga, Andalucia, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Andalucía, Spain

Hospital Carlos Haya; 🇪🇸 Malaga, Andalucia, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Andalucia, Spain

Consulta privada Dr. Rafael Cáliz; 🇪🇸 Granada, Andalucía, Spain

Hospital Quirón Málaga; 🇪🇸 Málaga, Andalucía, Spain

Hospital Comarcal de Melilla; 🇪🇸 Melilla, Spain

Clinica Xanit; 🇪🇸 Málaga, Andalucía, Spain