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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMARD´s and multidisciplinary treatment | Combination Product | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginia Pascual, MD | Contact | 00525555734111 | virtichu@gmail.com | |
| Irazú Contreras, Msc | Contact | 00525555734111 | protocolosar@live.com |
| Name | Affiliation | Role |
|---|---|---|
| Virginia Pascual, MD | INCMNSZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Recruiting | Mexico City | Tlalpan | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28754110 | Result | 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. | |
| 28865423 | Result | 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. |
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It is undecided yet.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Blood samples to asses serological status (rheumatoid arthritis antibodies)
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 27628666 | Result | 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. |
| 27442114 | Result | 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. |
| 26162892 | Result | 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. |
| 26939612 | Result | 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. |
| 25889060 | Result | 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. |
| 25190569 | Result | 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. |
| 25005131 | Result | 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. |
| 24435352 | Result | 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. |
| 24289729 | Result | 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. |
| 21477956 | Result | 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. |
| 20881757 | Result | 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. |
| 19276959 | Result | 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. |
| 19228421 | Result | 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |