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Completed

NCT Number: NCT02124031

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Quality of life

    Time frame: Previous six months

    For evaluate the impact in quality of life we will use the EUROQoL score

Secondary outcomes

  1. Articular function

    Time frame: Previous six months

    For evaluate the impact for articular function we will use the MDHAQ score, m-SACRAH score (hand) and WOMAC score (knee)

Sponsors and collaborators

Lead sponsor

Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide

Other

Collaborators

  • Sanofi
  • Webmedica

Registry information

Official study title

Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis

Acronym: IMPACTAR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2014
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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