Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR)

NCT ID: NCT02124031

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-10-31

Brief Summary

The purpose of this study is to evaluate quality of life, degree of disability, treatment patterns and economic impact of hand and knee Osteoarthritis and Rheumatoid Arthritis in Mexico.

Detailed Description

The osteoarthritis (OA) is a chronic and degenerative disease of multifactorial etiology, characterized by the gradual loss of articular cartilage. It is a question of one of the most common rheumatic disorders in the population, is the most habitual reason of pain and disability in the major adults and the first reason of surgeries of articular replacement. In Mexico, in a study of national area, the prevalence of locomotives manifestations was 26 %, with predominance in the women. Nowadays criteria exist for the classification of the OA, based on epidemiological studies, for the knee, the hip and the hand. Basically they have been established to homogenize studies of clinical epidemiological type. In other hand, the Rheumatoid Arthritis (RA) is an inflammatory, chronic, systemic disease that has more prominent manifestations in the diarthrodial joints. The disease have a wide range of characteristics, from the progressively chronic disease with variable degrees of destruction to articulate up to the extra-articular manifestations clinically evident. Demographically, the RA is the most common form of inflammatory arthritis and affects approximately 0.5 to 1 % of the world population, with an economic impact comparable with arterial coronary disease. The National Institute of Geographical Statistics (INEGI) thinks that in Mexico the population of major adults will double in the next decades, for what the impact of these rheumatic disorders will be serious and will turn into a problem of public health.

Based in the previous information, the Mexican Initiative of Patients with OA and RA (IMPACTAR), will on patient interview to increase the knowledge regarding the number of affected adults and the current treatment strategies.

This will be the first Mexican Registry related with Osteoarticular diseases.

Conditions

Physical Disability; Joint Function Disorder; Axis IV Problems Economic; Compliance Behavior; Complications; Arthroplasty

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Patients > 18 years with diagnosis of OA or RA according to the criteria of the American College of Rheumatology (ACR).

Exclusion Criteria

• Patients with precedents of fractures; carrying patients of chronic diseases who limit them in the functional capacity.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Webmedica

UNKNOWN

Sponsor Role: collaborator

Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolando Espinosa, M. D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Rehabilitation

Other Identifiers

IMPACTAR

Identifier Type: -

Identifier Source: org_study_id