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NCT Number: NCT04674085

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Health Behavior Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Treatment Adherence and Compliance

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. Evaluates the effects of tofacitinib therapy by measuring change in DAS 28-4 (ESR) and improvement in DAS-28

    Time frame: 6 months

    Clinical and laboratory parameters (DAS 28-4 (ESR), improvement in DAS-28) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.

  2. Evaluates the effects of tofacitinib therapy by measuring change in health assessment questionnaire score, visual analogue scale score

    Time frame: 6 months

    Clinical parameters (health assessment questionnaire score, visual analogue scale score) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.

  3. Evaluates the effects of tofacitinib therapy by measuring change in erythrocyte sedimentation rate (ESR)

    Time frame: 6 months

    Laboratory parameters (erythrocyte sedimentation rate (ESR)) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.

  4. Evaluates the effects of tofacitinib therapy by measuring change C-reactive protein (CRP) level

    Time frame: 6 months

    Laboratory parameters (C-reactive protein (CRP) level) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.

  5. Evaluates the effects of tofacitinib therapy by measuring change hemogram

    Time frame: 6 months

    Laboratory parameters (hemogram) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.

  6. Evaluates the effects of tofacitinib therapy by measuring change lipid parameters

    Time frame: 6 months

    Laboratory parameters (lipid parameters , Total Cholesterol; LDL, Low-Density Lipoprotein; HDL, High-Density Lipoprotein; TG, triglyceride) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.

  7. Evaluates the effects of tofacitinib therapy by measuring change uric asid

    Time frame: 6 months

    Laboratory parameters (uric asid) will be compared at the end of six months with baseline data in patients with rheumatoid arthritis refractory to conventional synthetic disease-modifying anti-rheumatic drugs and/or biological disease-modifying anti- rheumatic drugs.

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2020
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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