INCMNSZ - Rheumatoid Arthritis Cohort

NCT ID: NCT03389711

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-04

Study Completion Date

2024-02-04

Brief Summary

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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.

Detailed Description

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* 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

Conditions

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Early Rheumatoid Arthritis Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Virginia Pascual Ramos

Lead Investigator of the Rheumatoid Arthritis Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginia Pascual, MD

Role: PRINCIPAL_INVESTIGATOR

INCMNSZ

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Tlalpan, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Virginia Pascual, MD

Role: CONTACT

00525555734111

Irazú Contreras, Msc

Role: CONTACT

00525555734111

Facility Contacts

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Virginia Pascual, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 28754110 (View on PubMed)

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.

Reference Type RESULT
PMID: 28865423 (View on PubMed)

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.

Reference Type RESULT
PMID: 27628666 (View on PubMed)

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.

Reference Type RESULT
PMID: 27442114 (View on PubMed)

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.

Reference Type RESULT
PMID: 26162892 (View on PubMed)

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.

Reference Type RESULT
PMID: 26939612 (View on PubMed)

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.

Reference Type RESULT
PMID: 25889060 (View on PubMed)

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.

Reference Type RESULT
PMID: 25190569 (View on PubMed)

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.

Reference Type RESULT
PMID: 25005131 (View on PubMed)

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.

Reference Type RESULT
PMID: 24435352 (View on PubMed)

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.

Reference Type RESULT
PMID: 24289729 (View on PubMed)

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.

Reference Type RESULT
PMID: 21477956 (View on PubMed)

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.

Reference Type RESULT
PMID: 20881757 (View on PubMed)

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.

Reference Type RESULT
PMID: 19276959 (View on PubMed)

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.

Reference Type RESULT
PMID: 19228421 (View on PubMed)

Other Identifiers

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IRE-274-10/11-1

Identifier Type: -

Identifier Source: org_study_id

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