Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions

NCT ID: NCT03073109

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2019-09-16

Brief Summary

This study is aimed to describe the outcomes related to physical activity, activity of disease, quality of life, work productivity and safety in Latin-American patients with Rheumatoid Arthritis (RA) treated with tofacitinib or biological DMARDs after failure to respond to conventional DMARDs in real-life conditions. This will be a non-interventional, hybrid study (prospective and retrospective data collection) comparing tofacitinib to biologic DMARD treatments in patients with RA after failure of conventional DMARDs. The population will be composed by adult patients over 18 years of age diagnosed with RA and who have been prescribed tofacitinib or any biological DMARDs.

Conditions

Arthritis, Rheumatoid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients ≥ 18 years of age at the time of recruitment
• Patient diagnosed with moderate to severe RA ≥ 6 months before enrollment
• Patients who have had an inadequate response to the continuous use of methotrexate or combination of conventional DMARDs for at least 12 weeks before the study without dose change within the last 8 weeks before enrollment in the study
• Patients with no biological DMARDs use in patient history.
• Patients prescribed with tofacitinib or biological DMARDs in the last two weeks at doses established in ACR guidelines published in 2015 and following medical criteria.
• Acceptance for patients to participate in the study and signing of the informed consent.

Exclusion Criteria

• Patients who do not have the ability to answer the questionnaires by themselves or who have any kind of mental disorder that may affect their answers.
• Patients diagnosed with autoimmune rheumatic diseases other than RA and Sjogren's syndrome.
• Patients treated with biological DMARDs in monotherapy.
• Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation.
• Patients with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
• Patients with lymphoproliferative disorders (e.g., Epstein Barr Virus (EBV) related lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Artmedica

Medellín, Antioquia, Colombia

Fundacion Instituto de Reumatologia Fernando Chalem

Bogota, Cundinamarca, Colombia

IDEARG

Bogota, Cundinamarca, Colombia

Clinica de Occidente

Cali, Valle del Cauca Department, Colombia

Centro Integral de Reumatología del Caribe Circaribe S.A

Barranquilla, , Colombia

Clinicos IPS

Bogotá, , Colombia

Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM

Bogotá, , Colombia

SERVIMED

Bucaramanga, , Colombia

Fundacion Valle del Lili

Cali, , Colombia

REUMALAB

Medellín, , Colombia

Clínica San Judas Tadeo

Lima, SAN Miguel, Peru

Centro Medico CEEN

Arequipa, , Peru

Clinica Jockey Salud

Lima, , Peru

Countries

Colombia; Peru

References

Reyes JM, Gutierrez MV, Madariaga H, Otero W, Guzman R, Izquierdo J, Abello M, Velez P, Castillo D, Ponce de Leon D, Lukic T, Amador L. Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries. Reumatol Clin (Engl Ed). 2023 Jun-Jul;19(6):319-327. doi: 10.1016/j.reumae.2023.02.006.

Reference Type: DERIVED

PMID: 37286268 (View on PubMed)

Gutierrez-Ardila MV, Reyes J, Madariaga H, Otero W, Guzman R, Izquierdo J, Abello M, Velez P, Castillo D, Ponce de Leon D, Lukic T, Amador L. Work productivity in rheumatoid arthritis patients from two Latin American countries treated with tofacitinib or biological DMARDs. Expert Rev Pharmacoecon Outcomes Res. 2022 Jul;22(5):787-794. doi: 10.1080/14737167.2022.2047935. Epub 2022 Mar 16.

Reference Type: DERIVED

PMID: 35249439 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A3921284

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Other Identifiers

A3921284

Identifier Type: -

Identifier Source: org_study_id