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)

Rheumatoid Arthritis Clinical Trial

— SAR-FAME  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094326
• Other study ID #: SAR-FAM-2013-01
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: February 9, 2016
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2016
• Source: Fundación Andaluza de Reumatología
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Andaluza de Reumatología

Country where clinical trial is conducted

Spain, 

Outcome

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