Clinical trial NCT02094326: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Fundación Andaluza de Reumatología
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 years
Secondary outcomes:
measure: 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
timeFrame: 6 years
measure: Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal
timeFrame: 6 years
measure: 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
timeFrame: 6 years
measure: Percentage of Patients Who Receive Subcutaneous Methotrexate
timeFrame: 6 years
measure: Exposure Time of Methotrexate
timeFrame: 6 years
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Hospital Reina Sofía
state: Andalucia
city: Granada
country: Spain
facility: Hospital San Cecilio
state: Andalucia
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
state: Andalucia
city: Malaga
country: Spain
facility: Consulta Dra. Belmonte
state: Andalucia
city: Malaga
country: Spain
facility: Hospital Carlos Haya
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
state: Andalucia
city: Granada
country: Spain
facility: Consulta privada Dr. Rafael Cáliz
state: Andalucía
city: Málaga
country: Spain
facility: Hospital Quirón Málaga
state: Andalucía
city: Málaga
country: Spain
facility: Clinica Xanit
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
state: Andalucía
city: Melilla
country: Spain
facility: Hospital Comarcal de Melilla
Study officials:
affiliation: Fundacion Andaluza de Reumatologia
name: Federico Navarro, Dr.
role: STUDY_DIRECTOR
References: