Observational Registry of Patients With Rheumatoid Arthritis /Spondyloarthritis Using Biological or Targeted Synthetic DMARDs

NCT04139954 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1400

Last updated 2019-10-29

No results posted yet for this study

Summary

In this study, investigators aimed to observe the examination findings, laboratory findings and drugs used in routine polyclinic controls of the participants using biological and targeted synthetic disease-modifying antirheumatic drug (DMARD) and the doses and side effects of these drugs. The aim of this registry is to evaluate the real-life data of participants receiving these medications. Analysis of treatment follow-up, drug changes, causes of change, treatment-related paradoxic / immune reactions, compliance with adult vaccination programs, nutritional profiles, presence of metabolic syndrome, fertility status, pregnancy outcomes, and vitamin D levels will be recorded in the outpatient clinic. Rheumatoid Arthritis Impact of Disease, Psoriatic Arthritis Impact of Disease (RAID and PSAID indexes), Work Productivity and Activity Impairment Questionnaire (WPAI), drug compliance, central sensitization and fall risk will be evaluated with verbal evaluation forms performed at policlinic controls in patients with spondyloarthritis and rheumatoid arthritis. It is planned to conduct scientific analyzes and publish on various subjects from the recorded information on this registration system.

Patients using biological and targeted synthetic DMARD treatments are closely monitored and evaluated in many ways due to the risk profiles and various characteristics of the drugs. With this registry system, it is aimed to evaluate the real-life data of the participants using these drugs. Real-life data are very valuable in monitoring the disease and the drugs.

The study is observational and there is no expected risk since no intervention is planned.

Conditions

Interventions

OTHER

There is no intervention in the study

There is no intervention in the study

Sponsors & Collaborators

  • Turkish League Against Rheumatism

    lead OTHER

Principal Investigators

  • Hatice Bodur, Prof Dr · Turkish League Against Rheumatism

  • Şebnem Ataman, Prof Dr · Turkish League Against Rheumatism

  • Fatma G Yurdakul, MD · Turkish League Against Rheumatism

  • Özgür Akgül, AssocProf Dr · Turkish League Against Rheumatism

  • Erhan Çapkın, Prof Dr · Turkish League Against Rheumatism

  • Fatih Çay, AssocProf Dr · Turkish League Against Rheumatism

  • Remzi Çevik, Prof Dr · Turkish League Against Rheumatism

  • Tuncay Duruöz, Prof Dr · Turkish League Against Rheumatism

  • Feride Göğüş, Prof Dr · Turkish League Against Rheumatism

  • Gülcan Gürer, Prof Dr · Turkish League Against Rheumatism

  • Ayhan Kamanlı, Prof Dr · Turkish League Against Rheumatism

  • Meltem Alkan Melikoğlu, Prof Dr · Turkish League Against Rheumatism

  • Aylin Rezvani, AssocProf · Turkish League Against Rheumatism

  • İlhan Sezer, Prof Dr · Turkish League Against Rheumatism

  • İsmihan Sunar, MD · Turkish League Against Rheumatism

  • İlker Yağcı, Prof Dr · Turkish League Against Rheumatism

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-03-01
Completion
2024-03-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04139954 on ClinicalTrials.gov