Clinical trial NCT03389711: INCMNSZ - Rheumatoid Arthritis Cohort
Official title: INCMNSZ Early Rheumatoid Arthritis Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Rheumatoid Arthritis
Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Mexico
Early Rheumatoid Arthritis Cohort Mexico
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) belongs to the National Institutes of Health of México. Patients enrolled in the Early arthritis cohort had a disease duration of \<1 year when first evaluated, and no specific rheumatic diagnosis except for RA. Patients had partial health coverage and paid for their physician's consultations, laboratory investigations and for their treatment that was prescribed by the rheumatologist in charge of the clinic, and was "treat to target" oriented.

Brief summary: Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of the disease related symptoms. Initiate proper treatment according to international standards in order to achieve remission/low disease activity status.

Detailed description: * Provide an standardized follow up by a multidisciplinary specialized team.
* Create a biological (blood) bank to develop future research projects.
* Create a database with the clinical, serologic, radiographic and functional status patients data.
* Define comorbidities and mortality causes.
* Begin an educational program to improve patient disease self-knowledge

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old
* Fulfilled ACR 1987 classification criteria for RA
* Disease evolution of \<1 year when first evaluated, and no specific rheumatic diagnosis except for RA.

Exclusion Criteria:

* Patients with another rheumatic disease, except Sjögren syndrome.

Primary outcomes:
measure: Disease activity status
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Secondary outcomes:
measure: Change from Baseline of the Patient Reported Outcome : HAQ (Health Assessment Questionnarie)
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
measure: Change from Baseline of the Patient Reported Outcome: RADAI (Rheumatoid Arthritis Disease Activity Index)
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
measure: Change from Baseline of the Patient Reported Outcome : SF-36 (Short Form Health Survey)
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
measure: Predictors of health care drop-out
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
measure: Mayor Depressive Episodes (MDE)
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
measure: Michigan Hand Outcome Questionnarie (MHQ
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
measure: Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH)
timeFrame: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Tlalpan
Study officials:
affiliation: INCMNSZ
name: Virginia Pascual, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Contreras-Yanez I, Pascual-Ramos V. Predictors of health care drop-out in an inception cohort of patients with early onset rheumatoid arthritis. BMC Musculoskelet Disord. 2017 Jul 28;18(1):321. doi: 10.1186/s12891-017-1670-6.
citation: Contreras-Yanez I, Guaracha-Basanez G, Ruiz-Dominguez D, Pascual-Ramos V. Patient's perspective of sustained remission in rheumatoid arthritis. BMC Musculoskelet Disord. 2017 Sep 2;18(1):379. doi: 10.1186/s12891-017-1717-8.
citation: Romero-Guzman AK, Menchaca-Tapia VM, Contreras-Yanez I, Pascual-Ramos V. Patient and physician perspectives of hand function in a cohort of rheumatoid arthritis patients: the impact of disease activity. BMC Musculoskelet Disord. 2016 Sep 15;17:392. doi: 10.1186/s12891-016-1246-x.
citation: Atisha-Fregoso Y, Lima G, Pascual-Ramos V, Banos-Pelaez M, Fragoso-Loyo H, Jakez-Ocampo J, Contreras-Yanez I, Llorente L. Rheumatoid Arthritis Disease Activity Is Determinant for ABCB1 and ABCG2 Drug-Efflux Transporters Function. PLoS One. 2016 Jul 21;11(7):e0159556. doi: 10.1371/journal.pone.0159556. eCollection 2016.
citation: Contreras-Yanez I, Pascual-Ramos V. Window of opportunity to achieve major outcomes in early rheumatoid arthritis patients: how persistence with therapy matters. Arthritis Res Ther. 2015 Jul 11;17(1):177. doi: 10.1186/s13075-015-0697-z.
citation: Galicia-Hernandez G, Parra-Salcedo F, Ugarte-Martinez P, Contreras-Yanez I, Ponce-de-Leon A, Pascual-Ramos V. Sustained moderate-to-high disease activity and higher Charlson score are predictors of incidental serious infection events in RA patients treated with conventional disease-modifying anti-rheumatic drugs: a cohort study in the treat-to-target era. Clin Exp Rheumatol. 2016 Mar-Apr;34(2):261-9. Epub 2016 Mar 3.
citation: Parra-Salcedo F, Contreras-Yanez I, Elias-Lopez D, Aguilar-Salinas CA, Pascual-Ramos V. Prevalence, incidence and characteristics of the metabolic syndrome (MetS) in a cohort of Mexican Mestizo early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs: the complex relationship between MetS and disease activity. Arthritis Res Ther. 2015 Feb 20;17(1):34. doi: 10.1186/s13075-015-0549-x.
citation: Cabrera-Marroquin R, Contreras-Yanez I, Alcocer-Castillejos N, Pascual-Ramos V. Major depressive episodes are associated with poor concordance with therapy in rheumatoid arthritis patients: the impact on disease outcomes. Clin Exp Rheumatol. 2014 Nov-Dec;32(6):904-13. Epub 2014 Sep 5.
citation: Sanchez T, Contreras-Yanez I, Elias-Lopez D, Aguilar Salinas CA, Pascual-Ramos V. Prevalence of lipid phenotypes, serum lipid behaviour over follow-up and predictors of serum lipid levels in a cohort of Mexican Mestizo early rheumatoid arthritis patients treated with conventional disease-modifying anti-rheumatic drugs. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):509-15. Epub 2014 Jul 8.
citation: Pascual-Ramos V, Contreras-Yanez I, Rivera-Hoyos P, Enriquez L, Ramirez-Anguiano J. Cumulative disease activity predicts incidental hearing impairment in patients with rheumatoid arthritis (RA). Clin Rheumatol. 2014 Mar;33(3):315-21. doi: 10.1007/s10067-014-2485-6. Epub 2014 Jan 18.
citation: Pascual-Ramos V, Contreras-Yanez I. Motivations for inadequate persistence with disease modifying anti-rheumatic drugs in early rheumatoid arthritis: the patient's perspective. BMC Musculoskelet Disord. 2013 Dec 1;14:336. doi: 10.1186/1471-2474-14-336.
citation: Contreras-Yanez I, Rull-Gabayet M, Vazquez-Lamadrid J, Pascual-Ramos V. Radiographic outcome in Hispanic early rheumatoid arthritis patients treated with conventional disease modifying anti-rheumatic drugs. Eur J Radiol. 2011 Aug;79(2):e52-7. doi: 10.1016/j.ejrad.2011.03.036. Epub 2011 Apr 8.
citation: Contreras-Yanez I, Ponce De Leon S, Cabiedes J, Rull-Gabayet M, Pascual-Ramos V. Inadequate therapy behavior is associated to disease flares in patients with rheumatoid arthritis who have achieved remission with disease-modifying antirheumatic drugs. Am J Med Sci. 2010 Oct;340(4):282-90. doi: 10.1097/MAJ.0b013e3181e8bcb0.
citation: Pascual-Ramos V, Contreras-Yanez I, Cabiedes-Contreras J, Rull-Gabayet M, Villa AR, Vazquez-Lamadrid J, Mendoza-Ruiz JJ. Hypervascular synovitis and American College of Rheumatology Classification Criteria as predictors of radiographic damage in early rheumatoid arthritis. Ultrasound Q. 2009 Mar;25(1):31-8. doi: 10.1097/RUQ.0b013e3181981df0.
citation: Pascual-Ramos V, Contreras-Yanez I, Villa AR, Cabiedes J, Rull-Gabayet M. Medication persistence over 2 years of follow-up in a cohort of early rheumatoid arthritis patients: associated factors and relationship with disease activity and with disability. Arthritis Res Ther. 2009;11(1):R26. doi: 10.1186/ar2620. Epub 2009 Feb 19.