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

Last updated: October 25, 2019
Sponsor: Turkish League Against Rheumatism
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ankylosing Spondylitis

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT04139954
TRASD
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological ortargeted synthetic DMARD treatment

Exclusion

Exclusion Criteria: Aged under 18 years old

Study Design

Total Participants: 1400
Study Start date:
February 01, 2019
Estimated Completion Date:
March 01, 2024

Study Description

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.

Planned studies are:

ROMATOID ARTHRITIS CLINICAL DEMOGRAPHIC ASSESSMENT / DISEASE EFFECT / DRUGS

  • SPONDYLOARTHRITIS CLINICAL DEMOGRAPHIC EVALUATION / DISEASE EFFECT / DRUGS

  • COMORBIDITY IN ROMATOID ARTHRITIS

  • COMORBIDITY IN SPONDYLOARTHRITIS

  • RE ACTIVITATION AND SAFETY MONITORING IN VIRAL HEPATITIS

  • TREATMENT PARADOXIC / IMMUNE REACTIONS (SYSTEMIC AUTOIMMUNE, ARTHRITIS, HEMATOLOGIC, NEUROLOGIC, PULMONARY, OPHTHALMOLOGICAL, INFLAMMATORY BOWEL DISEASE, LIVER, CUTANEOUS, OTHER)

  • WORK FORCE LOSS IN AXIAL SPONDYLOARTHRITIS

  • WORK FORCE LOSS IN PSORIATIC ARTHRITIS

  • WORK FORCE LOSS IN ROMATOID ARTHRITIS

  • PREGNANCY / FERTILITY OUTCOMES

  • TUBERCULOSIS MONITORING

  • DRUG SWITCH ANALYSIS

  • THROID DISEASE IN EARLY AND ESTABLISHED ROMATOID ARTHRITIS (AUTOIMMUNE THROIDITIS, MALIGNITY etc)

  • TREATMENT COMPLIANCE IN RHEUMATIC DISEASES

  • ADULT IMMUNIZATION PROGRAM IN RHEUMATIC DISEASES

  • METABOLIC SYNDROME ASSESSMENT

  • CARDIOVASCULAR RISK ASSESSMENT

  • FALL / FRACTURE AND RELATED VARIABLES IN RHEUMATIC DISEASES

  • VITAMIN D STATUS IN RHEUMATIC DISEASES

  • CENTRAL SENSITIZATION AND PAIN IN ROMATOID ARTHRITIS AND SPONDYLOARTROPATHIES AND RELATED VARIABLES The study is observational and there is no expected risk since no intervention is planned.

Connect with a study center

  • Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation

    Ankara,
    Turkey

    Active - Recruiting

  • Ankara University, Faculty of Medicine, Department of Rheumatology

    Ankara,
    Turkey

    Active - Recruiting

  • Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology

    Ankara,
    Turkey

    Active - Recruiting

  • Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Antalya,
    Turkey

    Active - Recruiting

  • Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic

    Antalya,
    Turkey

    Active - Recruiting

  • Adnan Menderes University, Faculty of Medicine, Department of Rheumatology

    Aydın,
    Turkey

    Active - Recruiting

  • Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Diyarbakır,
    Turkey

    Active - Recruiting

  • Istanbul Medipol University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Istanbul,
    Turkey

    Active - Recruiting

  • Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Istanbul,
    Turkey

    Active - Recruiting

  • Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology

    Istanbul,
    Turkey

    Active - Recruiting

  • Celal Bayar University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Manisa,
    Turkey

    Active - Recruiting

  • Sakarya University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Sakarya,
    Turkey

    Active - Recruiting

  • Atatürk University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Sivas,
    Turkey

    Active - Recruiting

  • Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    Trabzon,
    Turkey

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.