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

NCT ID: NCT07182630

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-01-30

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.

Detailed Description

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.

Conditions

Rheumatoid Arthritis (RA

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

People Using Anti-TNF-α Medication

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

No interventions assigned to this group

People Using Non-TNF-α Medication

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Firat University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Seçkin Korkmaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Songül BAĞLAN YENTÜR, Doç. Dr.

Role: STUDY_DIRECTOR

Firat University

Locations

Fırat University

Elâzığ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ahmet S KORKMAZ

Role: CONTACT

fztseckinkorkmaz@hotmail.com

+905425491901

Facility Contacts

Ahmet Seçkin Korkmaz

Role: primary

fztseckinkorkmaz@hotmail.com

05425491901

Other Identifiers

FU-FTR-ASK-01

Identifier Type: -

Identifier Source: org_study_id