Rheumatoid Arthritis, Spondyloarthritis
Conditions
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.
Interventions
There is no intervention in the study
Sponsors
Turkish League Against Rheumatism
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Disease activity-SpA2 | 24 weeks | BASDAI score will be calculated |
Other
| Measure | Time frame | Description |
|---|---|---|
| PSAID (Psoriatic Arthritis Impact of Disease Questionnaire) | an average of 1 year | Psoriatic Arthritis Impact of Disease Questionnaire |
| DN-4 (Douleur Neuropathic 4 Questionnaire) questions) | an average of 1 year | Neuropathic pain questionnaire |
| Cardiovascular disease risk | 1 year | HDL and LDL cholesterol (mg/dl) levels from records , hypertension and diabetes history will be evaluated |
| SF-36 (Short form 36) | an average of 1 year | Quality of life questionnaire |
| HAQ (Health assessment questionnaire) | an average of 1 year | Functional assessment, Questionnaire |
| ASAS-HI (ASAS Health Index) | an average of 1 year | ASAS Health Index |
| Fibromyalgia and central sensitization | an average of 2 year | Fibromyalgia criteria and central sensitization will be questioned |
| Demographic characteristics -Age | It will be evaluated at the beginning of the study | Age, years |
| Demographic characteristics -Gender | It will be evaluated at the beginning of the study | female/ male |
| Demographic characteristics- smoking | It will be evaluated at the beginning of the study | Amount of smoking (packet-year) |
| Demographic characteristics- alcohol use | It will be evaluated at the beginning of the study | How much and how often drink |
| Demographic characteristics- education | It will be evaluated at the beginning of the study | Illiterate, literate, years of training |
| Demographic characteristics- fertility and pregnancy history | It will be evaluated at the beginning of the study | In her history; pregnancy, abortus, stillbirth, live birth, anomalies number |
| Demographic characteristics, body mass index (kg/m2) | an average of 2 year | Height (cm) |
| Physical examination hand deformities, | It will be evaluated at the beginning of the study | subluxation, deviation, swan neck, button marrow deformities in hand examination |
| Lung involvement | an average of 2 year | Known pulmonary involvement, pulmonary function test and computed tomography results |
| Neurological involvement | an average of 2 year | Existing entrapment neuropathy, central involvement will be recorded |
| Laboratory- Urea | an average of 1 year | Urea levels from records |
| Laboratory- creatinine | an average of 1 year | Creatinine levels from records |
| Laboratory- liver function tests | an average of 1 year | Liver function tests from records |
| Laboratory-vitamin D | an average of 1 year | Vitamin D levels from records |
| Laboratory-hemoglobin | an average of 1 year | hemoglobin levels from records |
| Laboratory-leukocyte | an average of 1 year | leukocyte levels from records |
| Laboratory-platelet | an average of 1 year | platelet levels from records |
| Laboratory-Rheumatoid factor (RF) | It will be evaluated at the beginning | Rheumatoid factor (RF) levels from records |
| Laboratory-anticyclic citrullinated peptide (Anti CCP) | It will be evaluated at the beginning | Anti CCP levels from records |
| Laboratory-Lipid profile | an average of 2 year | LDL, HDL, Triglycerin, Cholesterol levels from records |
| Laboratory-hepatitis serology | an average of 2 year | HBs Ag, Anti HBs, HBc Ag, HBe Ag, Anti HBC levels from records, receiving antiviral treatment for hepatitis, hepatitis reactivation history will be questioned |
| Laboratory-HIV serology | an average of 2 year | Anti HIV levels from records |
| Imaging findings- X Ray | It will be evaluated at the beginning | Hand wrist and pelvis X ray from records |
| Imaging findings- magnetic resonance imaging | It will be evaluated at the beginning | Sacroiliac joint MRI from records |
| Imaging findings- Ultrasound | It will be evaluated at the beginning | Hand ultrasound from records |
| Imaging findings- Bone Mineral density | an average of 2 year | Bone Mineral density from records |
| Comorbidity | It will be evaluated at the beginning | Presence of hypertension, diabetes, autoimmune thyroiditis, metabolic syndrome, coronary artery disease, chronic renal failure,pulmonary dieses, gastric ulcer, anxiety, depression, surgeries, cancer from patient records |
| Fall risk | It will be evaluated at the beginning | The number of falls in the last year, the feeling of walking imbalance and the fear of falling and fracture history |
| Evaluation of tuberculosis | It will be evaluated at the beginning | PPD / quantiferon result and INH use before drug initiation |
| Vaccination program | It will be evaluated at the beginning | Applied hepatitis, tuberculosis, pneumonia, influenza vaccination programme |
| Drugs | an average of 1 year | All drugs and doses previously used in relation to rheumatic disease will be questioned. Side effects, autoimmune/ paradoxic reactions and switching of drugs from records will be checked |
| Demographic characteristics, menopause | It will be evaluated at the beginning of the study | presence of menopause |
| MASES | an average of 1 year | Maastricht Ankylosing Spondylitis Enthesitis Score |
| PASI | an average of 1 year | The Psoriasis Area Severity Index |
| BASMI | an average of 2 year | Bath Ankylosing Spondylitis Metrology Index |
| WPAI (Work Productivity and Activity Impairment Questionnaire) | an average of 1 year | Work Productivity and Activity Impairment Questionnaire: |
| RAID (Rheumatoid Arthritis Impact of Disease Questionnaire) | an average of 1 year | Rheumatoid Arthritis Impact of Disease Questionnaire |
Countries
Turkey (Türkiye)
Contacts
Primary ContactFatma G Yurdakul, MD
Backup ContactHatice Bodur, Prof Dr
Outcome results
None listed