Observational Registry (BioSTaR) Including Demographic and Clinical Data of Patients Diagnosed With Rheumatoid Arthritis and Spondyloarthritis Using a Biological and Targeted Synthetic Disease Modifying Drug
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,400
- Locations
- 14
- Primary Endpoint
- Disease activity-SpA2
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment
Exclusion Criteria
- •Aged under 18 years old
Outcomes
Primary Outcomes
Disease activity-SpA2
Time Frame: 24 weeks
BASDAI score will be calculated
Disease activity RA
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Fatma Gül Yurdakul
Clinical Associate Professor (Fatma Gül Yurdakul)
Turkish League Against Rheumatism