Clinical trial NCT04674085: Real-life Experience of Tofacitinib in Patients With Treatment-Resistant Rheumatoid Arthritis
Official title: Real-life Experience of Tofacitinib in Patients With Treatment-Resistant Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Treatment Adherence and Compliance
Keywords: Rheumatoid Arthritis
tofacitinib
disease activity
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective cohort study

Brief summary: The investigators aimed to present the efficacy and safety data for patients with RA who received tofacitinib therapy in outpatient clinics.

Detailed description: This retrospective cohort study included 35 patients with rheumatoid arthritis who received tofacitinib therapy in rheumatology outpatient clinic between June 2015 and December 2019. Patients who received tofacitinib due to unresponsiveness to ≥2 conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and/or ≥1 biological disease-modifying anti-rheumatic drugs (bDMARDs) were retrospectively evaluated. Demographic characteristics of the patients, the disease activity score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS 28-4 (ESR)), change in DAS-28, health assessment questionnaire score, visual analogue scale score, and laboratory parameters such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, hemogram, lipid parameters, and uric acid were recorded. The data at six months of treatment were compared with baseline data. The effects related to the treatment as well as the undesired consequences were evaluated.

Eligibility criteria: Inclusion Criteria:

Patients who received tofacitinib due to unresponsiveness to ≥2 csDMARDs and/or ≥1 bDMARDs were retrospectively evaluated.

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Exclusion Criteria:

Patients who could not tolerate the treatment and whose follow-up results could not be reached were excluded from the study.

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Primary outcomes:
measure: Evaluates the effects of tofacitinib therapy by measuring change in DAS 28-4 (ESR) and improvement in DAS-28
timeFrame: 6 months
measure: Evaluates the effects of tofacitinib therapy by measuring change in health assessment questionnaire score, visual analogue scale score
timeFrame: 6 months
measure: Evaluates the effects of tofacitinib therapy by measuring change in erythrocyte sedimentation rate (ESR)
timeFrame: 6 months
measure: Evaluates the effects of tofacitinib therapy by measuring change C-reactive protein (CRP) level
timeFrame: 6 months
measure: Evaluates the effects of tofacitinib therapy by measuring change hemogram
timeFrame: 6 months
measure: Evaluates the effects of tofacitinib therapy by measuring change lipid parameters
timeFrame: 6 months
measure: Evaluates the effects of tofacitinib therapy by measuring change uric asid
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
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