Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07182630

Investigation Of The Effects Of Anti-Tnf-Α And Non-Tnf-Α Drugs İn Patients With Rheumatoid Arthritis

In RA, joint structure is damaged due to destructive inflammation in the synovium. This condition negatively affects the patient's level of physical activity. As the patient becomes more immobile, their muscle mass and strength decrease and their aerobic capacity declines. One of the drug groups used in the pharmacological treatment of RA is anti-TNF-α drugs. The aim of this study is to investigate the effects of anti-TNF-α and non-TNF-α drug treatments on aerobic capacity, muscle strength, fatigue, cardiorespiratory risk factors, and disease activity in RA patients.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

The basic principle in the treatment of rheumatoid arthritis is to prolong the period of remission in patients. Even if complete remission is not achieved, improvements in symptoms and clinical findings enable patients to maintain their functional capacity at a certain level, which is important for their quality of life. To this end, a multidisciplinary approach involving exercise therapy, pharmacological treatment, and psychological support is applied. The primary goal of pharmacological treatment is to intervene in inflammatory pathways. While there are studies in the literature on the relationship of these pharmacological agents with other disease-related mediators and the clinical course of the disease, no studies have been found that examine the relationship between aerobic capacity, which is one of the basic indicators of the patient's functional level, and fatigue, cardiorespiratory risk factors, and quality of life, which are related to aerobic capacity. Based on the results of the study, the aim was to compare the effects of anti-TNF-α and non-TNF-α drugs on aerobic capacity, fatigue, muscle strength, cardiovascular disease risk factors, and disease activity in RA patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with RA according to the 2010 American College of Rheumatology (ACR-2010) criteria
  • Be between 18 and 65 years of age
  • Be literate
  • Have been using one of the anti-TNF-α or non-TNF-α drugs for a period of 1-3 years

Exclusion criteria

  • Being pregnant or having a diagnosis of malignancy
  • Having a dysfunction that would limit physical activity (cycling for aerobic capacity assessment), such as severe neurological involvement, immobility, or incooperation
  • Having a regular exercise habit (reporting a habit of exercising 3 or more days per week)
  • Having another chronic disease
  • Having cardiac symptoms according to the New York Heart Association
  • Having mental problems that prevent participation in assessments

Treatment and study plan

Primary outcomes

  1. Maximal Oxygen Consumption

    Time frame: First Day 1

    VO2max will be assessed using Cosmed FitMate Pro® (Cosmed, Italy). The FitMate Pro® includes a turbine flow meter to measure ventilation and a galvanic fuel cell oxygen sensor to analyze the oxygen fraction in exhaled gases. The FitMate Pro® performs self-calibration before each measurement. A face mask will be placed over the participant's face to sample exhaled air, which will then be connected to the turbine flow meter. After resting for 5 minutes (while seated on the ergometer), participants will be asked to begin pedaling on the bicycle ergometer (E200 Cosmed®, Italy) starting at 25W. The load will be increased by 25W every 3 minutes until exhaustion.

Other outcomes

  1. Fatigue Severity Scale

    Time frame: First Day 1

    There are nine questions related to fatigue on this scale. Patients are asked to rate these questions on a scale of 1 to 7. The assessment results in a score between 9 and 63. A higher score indicates greater fatigue.

  2. Sarcopenia assessment

    Time frame: First Day 1

    In the assessment of sarcopenia, patients' gross grip strength will be evaluated. Gross grip strength will be assessed using the Jamar Hand Dynamometer. The Jamar Hand Dynamometer is a method recommended by the American Association of Occupational Therapists (AAOT) for measuring hand grip strength, and is considered the gold standard with proven validity and reliability.

  3. Cardiovascular Disease Risk Factors

    Time frame: First Day 1

    Cardiovascular risk factors will be assessed using Framingham risk factors. The risk factors assessed in the Framingham Risk Score are age, gender, total cholesterol level, HDL cholesterol level, systolic blood pressure/use of medication for high blood pressure, and smoking. In the Framingham Risk Score, patients are categorized into three groups: high, moderate, and low risk. Patients with a 10-year risk of adverse events >20% are considered high risk, those with a risk of 10-20% are considered moderate risk, and those with a risk of <10% are considered low risk.

  4. Quality of Life Assessment

    Time frame: First Day 1

    The scale was developed for use in individuals with RA and is designed to be completed by the patients themselves. The scale consists of 30 questions, which are scored as "yes-1" and "no-0." The resulting scores range from 0 to 30, with higher scores indicating poorer quality of life.

  5. Disease Activity Assessment

    Time frame: First Day 1

    The Disease Activity Score-28 (DAS-28) will be used to assess disease activity. Twenty-eight joints, including fingers, wrists, elbows, shoulders, and knees, are examined for tenderness and swelling. Patients are asked to assign a score between 0 and 100 for their overall well-being. Erythrocyte sedimentation rate (ESR) and C-reactive protein are determined, and DAS-28 is calculated using all of these data. High scores indicate high disease activity

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet S KORKMAZ

CONTACT

[email protected]

+905425491901

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

Investigation Of The Effects Of Anti-Tnf-Α And Non-Tnf-Α Drugs On Aerobic Capacity, Muscle Strength, Fatigue, Cardiovascular Disease Risk Factors, And Disease Activity İn Patients With Rheumatoid Arthritis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

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.

Published trials that share one or more normalized conditions with this study.