Clinical trial NCT03073109: Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions
Official title: PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB OR BIOLOGICAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN REAL LIFE CONDITIONS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 170
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: Adult patients ≥ 18 years of age diagnosed with RA and who failed to respond to conventional DMARDs, and have been prescribed tofacitinib or any biological DMARDs

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.


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.

Primary outcomes:
measure: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
timeFrame: Baseline, Month 6
measure: European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6
timeFrame: Baseline, Month 6
measure: Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
timeFrame: Month 6
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6
timeFrame: Baseline, Month 6
measure: Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
timeFrame: Month 6
measure: Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
timeFrame: Baseline, Month 6
measure: Number of Participants With Serious Adverse Event (SAE) and Non-serious Adverse Events (AEs)
timeFrame: Baseline up to Month 6
measure: Number of Participants With Serious Infections
timeFrame: Baseline up to Month 6
measure: Number of Participants Who Withdrew From Study Due to Adverse Events And Due to All Causes
timeFrame: Baseline up to Month 6
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Artmedica
state: Antioquia
city: Bogota
country: Colombia
facility: Fundacion Instituto de Reumatologia Fernando Chalem
state: Cundinamarca
city: Bogota
country: Colombia
facility: IDEARG
state: Cundinamarca
city: Cali
country: Colombia
facility: Clinica de Occidente
state: Valle
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe Circaribe S.A
city: Bogota
country: Colombia
facility: Clinicos IPS
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM
city: Bucaramanga
country: Colombia
facility: SERVIMED
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
city: Medellin
country: Colombia
facility: REUMALAB
city: Lima
country: Peru
facility: Clínica San Judas Tadeo
state: SAN Miguel
city: Arequipa
country: Peru
facility: Centro Medico CEEN
city: Lima
country: Peru
facility: Clinica Jockey Salud
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.