Real-life Experience of Tofacitinib in Patients With Treatment-Resistant Rheumatoid Arthritis

NCT ID: NCT04674085

Last Updated: 2020-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2019-12-30

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.

Conditions

Rheumatoid Arthritis; Treatment Adherence and Compliance

Study Design

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

Eligibility Criteria

Inclusion Criteria

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

-

Exclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sibel Ocak Serin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Umraniye ERH

Identifier Type: -

Identifier Source: org_study_id