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)

NCT02094326 | Completed Results

• 1 other identifier: SAR-FAM-2013-01
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 11

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Percentage of Patients Who Receive Subcutaneous Methotrexate

  6 years

• Exposure Time of Methotrexate

  6 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rheumatoid arthritis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Andaluza de Reumatología: lead

Study Sites (11)

Hospital Reina Sofía

Córdoba, Andalusia, Spain

Location

Consulta privada Dr. Rafael Cáliz

Granada, Andalusia, 18014, Spain

Location

Hospital San Cecilio

Granada, Andalusia, Spain

Location

Hospital Virgen de las Nieves

Granada, Andalusia, Spain

Location

Hospital Quirón Málaga

Málaga, Andalusia, 29004, Spain

Location

Clinica Xanit

Málaga, Andalusia, 29630, Spain

Location

Consulta Dra. Belmonte

Málaga, Andalusia, Spain

Location

Hospital Carlos Haya

Málaga, Andalusia, Spain

Location

Hospital Virgen Macarena

Seville, Andalusia, 41071, Spain

Location

Hospital Virgen del Rocío

Seville, Andalusia, Spain

Location

Hospital Comarcal de Melilla

Melilla, Melilla, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Federico Navarro Sarabia
• Organization: Hospital Virgen de la Macarena

federico.navarro.sarabia@gmail.com

+34 955 00 80 00

Study Officials

• Federico Navarro, Dr.

  Fundacion Andaluza de Reumatologia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 21, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 8, 2016
• Results First Posted: March 8, 2016

Record last verified: 2016-02

Locations

ES (11)