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

Physical Disability Clinical Trial

— IMPACTAR  

Official title:

Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124031
• Other study ID #: IMPACTAR
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: October 22, 2015
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10241
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Axis IV Problems Economic
• Compliance Behavior
• Complications; Arthroplasty
• Joint Function Disorder
• Osteoarthritis
• Physical Disability

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Iniciativa Mexicana de Pacientes con Osteoartritis y Artritis Reumatoide	Sanofi, Webmedica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	For evaluate the impact in quality of life we will use the EUROQoL score	Previous six months	No
Secondary	Articular function	For evaluate the impact for articular function we will use the MDHAQ score, m-SACRAH score (hand) and WOMAC score (knee)	Previous six months	No