INCMNSZ - Rheumatoid Arthritis Cohort

Rheumatoid Arthritis Clinical Trial

— IRAC  

Official title:

INCMNSZ Early Rheumatoid Arthritis Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03389711
• Other study ID #: IRE-274-10/11-1
• Status: Recruiting
• Start date: February 4, 2004
• Est. completion date: February 4, 2024

Study information

• Verified date: August 2021
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: Virginia Pascual, MD
• Phone: 00525555734111
• Email: virtichu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 237
• Est. completion date: February 4, 2024
• Est. primary completion date: February 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Early Rheumatoid Arthritis
• Rheumatoid Arthritis

Intervention

Combination Product:
• DMARD´s and multidisciplinary treatment
At study enrollment, medical history, disease-specific autoantibodies, ACR 1987 classification criteria for RA were applied. Medical evaluations were standardized and included at least 66 swollen and 68 tender joint counts, acute reactant-phase determinations , patient and physician reported outcomes, comorbidity established by record review, and treatment assessments (name, dose and schedule of all drug they were taking) along with an evaluation of persistence, at six-month intervals. Patients were evaluated by a single rheumatologist every two months during the first two years of follow-up, and every two, four or six months thereafter. Also the following scores: Michigan Hand Outcome Questionnaire (MHQ), Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH),Mayor Depressive Episodes (MDE) was defined using the Mini International Neuropsychiatric Interview and the severity of depressive symptoms was assessed with the Beck Depression Inventory (BDI-II).

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (15)

Atisha-Fregoso Y, Lima G, Pascual-Ramos V, Baños-Peláez M, Fragoso-Loyo H, Jakez-Ocampo J, Contreras-Yáñez I, Llorente L. Rheumatoid Arthritis Disease Activity Is Determinant for ABCB1 and ABCG2 Drug-Efflux Transporters Function. PLoS One. 2016 Jul 21;11( — View Citation

Cabrera-Marroquín R, Contreras-Yáñez 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; — View Citation

Contreras-Yáñez I, Guaracha-Basañez G, Ruiz-Domínguez 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. — View Citation

Contreras-Yáñez 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. — View Citation

Contreras-Yáñez 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;17:177. doi: 10.1186/s13075-015-0697-z. — View Citation

Contreras-Yáñez I, Ponce De León 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 — View Citation

Contreras-Yáñez I, Rull-Gabayet M, Vázquez-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 — View Citation

Galicia-Hernández G, Parra-Salcedo F, Ugarte-Martínez P, Contreras-Yáñez I, Ponce-de-León A, Pascual-Ramos V. Sustained moderate-to-high disease activity and higher Charlson score are predictors of incidental serious infection events in RA patients treate — View Citation

Parra-Salcedo F, Contreras-Yáñez I, Elías-López 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 — View Citation

Pascual-Ramos V, Contreras-Yañez I, Cabiedes-Contreras J, Rull-Gabayet M, Villa AR, Vázquez-Lamadrid J, Mendoza-Ruiz JJ. Hypervascular synovitis and American College of Rheumatology Classification Criteria as predictors of radiographic damage in early rhe — View Citation

Pascual-Ramos V, Contreras-Yáñez I, Rivera-Hoyos P, Enríquez L, Ramírez-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/s10067-0 — View Citation

Pascual-Ramos V, Contreras-Yáñez 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. A — View Citation

Pascual-Ramos V, Contreras-Yáñez 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. — View Citation

Romero-Guzmán AK, Menchaca-Tapia VM, Contreras-Yáñez 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: 1 — View Citation

Sánchez T, Contreras-Yáñez I, Elías-López 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 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity status	Describe the disease activity score using DAS 28 ESR	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	Change from Baseline of the Patient Reported Outcome : HAQ (Health Assessment Questionnarie)	To describe the changes in every visit in the HAQ score	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	Change from Baseline of the Patient Reported Outcome: RADAI (Rheumatoid Arthritis Disease Activity Index)	To describe the changes in every visit in the RADAI score	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	Change from Baseline of the Patient Reported Outcome : SF-36 (Short Form Health Survey)	To describe the changes in every visit in the SF-36 score	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	Predictors of health care drop-out	Identify and describe patients from an inception ongoing cohort with recent onset RA at inclusion, who dropped out of health care during their follow-up	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	Mayor Depressive Episodes (MDE)	Investigate associations between major depressive episodes (MDE), concordance with therapy (CwT) and disease outcomes in rheumatoid arthritis patients.	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	Michigan Hand Outcome Questionnarie (MHQ	To assess a variety of hand and upper extremity injuries related to Rheumatoid Arthritis	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	Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH)	To measure upper-extremity disability and symptoms	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.