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

• Conditions: Rheumatoid Arthritis; Spondyloarthritis
• Interventions: Other: There is no intervention in the study

• Registration Number: NCT04139954
• Lead Sponsor: Turkish League Against Rheumatism

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-09-01
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29
• Primary Completion: 2020-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment

Exclusion Criteria

Aged under 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis and Spondyloarthritis	There is no intervention in the study	Patients using Biological or Targeted Synthetic DMARDs

Primary Outcome Measures

Name	Time	Method
Disease activity-SpA2	24 weeks	BASDAI score will be calculated
Disease activity RA	24 weeks	DAS 28 score will be calculated (Sensitive and swollen joints, VAS pain score, patient's global assessment and CRP / ESH values will be used for scoring)
Disease activity- SpA1	24 weeks	ASDAS score will be calculated (Sensitive and swollen joints, VAS pain score, patient's global assessment and CRP / ESH values will be used for scoring)

Trial Locations

Locations (14)

Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation; 🇹🇷 Ankara, Turkey

Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology; 🇹🇷 Ankara, Turkey

Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic; 🇹🇷 Antalya, Turkey

Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Antalya, Turkey

Adnan Menderes University, Faculty of Medicine, Department of Rheumatology; 🇹🇷 Aydın, Turkey

Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Diyarbakır, Turkey

Istanbul Medipol University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Istanbul, Turkey

Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology; 🇹🇷 Istanbul, Turkey

Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Istanbul, Turkey

Celal Bayar University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Manisa, Turkey

Sakarya University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Sakarya, Turkey

Atatürk University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Sivas, Turkey

Ankara University, Faculty of Medicine, Department of Rheumatology; 🇹🇷 Ankara, Turkey

Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation; 🇹🇷 Trabzon, Turkey