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

NCT07182630 | Not Yet Recruiting

• 1 other identifier: FU-FTR-ASK-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA

Keywords

Anti TNF-α; Non TNF-α; Rheumatoid arthritis; Aerobic Capacity

Outcome Measures

Primary Outcomes (1)

• Maximal Oxygen Consumption

  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.

  First Day 1

Other Outcomes (5)

• Fatigue Severity Scale

  First Day 1

• Sarcopenia assessment

  First Day 1

• Cardiovascular Disease Risk Factors

  First Day 1

Study Arms (2)

People Using Anti-TNF-α Medication

20 participants will consist of patients using anti-TNF-α drugs.

People Using Non-TNF-α Medication

20 participants will consist of patients using non-TNF-α drugs.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only female participants will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include 40 patients aged 18-65 who are being followed up at the Department of Rheumatology at Fırat University Hospital and who have been diagnosed with RA according to the 2010 RA criteria of the American College of Rheumatology (ACR).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat University

Elâzığ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Songül BAĞLAN YENTÜR, Doç. Dr.

  Firat University

  STUDY DIRECTOR

Central Study Contacts

Ahmet S KORKMAZ

CONTACT

+905425491901; fztseckinkorkmaz@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)