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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis and Spondyloarthritis | Patients using Biological or Targeted Synthetic DMARDs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no intervention in the study | Other | There is no intervention in the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity RA | 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) | 24 weeks |
| Disease activity- SpA1 | 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) | 24 weeks |
| Disease activity-SpA2 | BASDAI score will be calculated | 24 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| WPAI (Work Productivity and Activity Impairment Questionnaire) | Work Productivity and Activity Impairment Questionnaire: | an average of 1 year |
| RAID (Rheumatoid Arthritis Impact of Disease Questionnaire) |
Inclusion Criteria:
Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment
Exclusion Criteria:
Aged under 18 years old
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The study population will consist of patients followed in rheumatology and physical medicine and rehabilitation clinics in tertiary hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma G Yurdakul, MD | Contact | +905059254214 | fatmagulonder@gmail.com | |
| Hatice Bodur, Prof Dr | Contact | +905054848496 | haticebodur@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hatice Bodur, Prof Dr | Turkish League Against Rheumatism | Study Director |
| Şebnem Ataman, Prof Dr | Turkish League Against Rheumatism | Study Director |
| Fatma G Yurdakul, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation | Recruiting | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35353263 | Derived | Bodur H, Yurdakul FG, Ataman S, Cay HF, Gurer G, Capkin E, Sezer I, Duruoz MT, Melikoglu MA, Rezvani A, Yagci I, Gogus F, Kamanli A, Akgul O, Cevik R. Where we are in treat to target era? Predictive factors for remission and drug switching in patients with axial spondyloarthritis: a real-life evidence from BioStaR nationwide registry. Clin Rheumatol. 2022 Jul;41(7):2053-2063. doi: 10.1007/s10067-022-06145-8. Epub 2022 Mar 30. |
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All of the collected data will be shared with investigators of the study
After the end of the study
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Rheumatoid Arthritis Impact of Disease Questionnaire
| an average of 1 year |
| PSAID (Psoriatic Arthritis Impact of Disease Questionnaire) | Psoriatic Arthritis Impact of Disease Questionnaire | an average of 1 year |
| DN-4 (Douleur Neuropathic 4 Questionnaire) questions) | Neuropathic pain questionnaire | an average of 1 year |
| Cardiovascular disease risk | HDL and LDL cholesterol (mg/dl) levels from records , hypertension and diabetes history will be evaluated | 1 year |
| SF-36 (Short form 36) | Quality of life questionnaire | an average of 1 year |
| HAQ (Health assessment questionnaire) | Functional assessment, Questionnaire | an average of 1 year |
| ASAS-HI (ASAS Health Index) | ASAS Health Index | an average of 1 year |
| Fibromyalgia and central sensitization | Fibromyalgia criteria and central sensitization will be questioned | an average of 2 year |
| Demographic characteristics -Age | Age, years | It will be evaluated at the beginning of the study |
| Demographic characteristics -Gender | female/ male | It will be evaluated at the beginning of the study |
| Demographic characteristics- smoking | Amount of smoking (packet-year) | It will be evaluated at the beginning of the study |
| Demographic characteristics- alcohol use | How much and how often drink | It will be evaluated at the beginning of the study |
| Demographic characteristics- education | Illiterate, literate, years of training | It will be evaluated at the beginning of the study |
| Demographic characteristics- fertility and pregnancy history | In her history; pregnancy, abortus, stillbirth, live birth, anomalies number | It will be evaluated at the beginning of the study |
| Demographic characteristics, body mass index (kg/m2) | Height (cm) | an average of 2 year |
| Demographic characteristics, body mass index (kg/m2) | Weight (kg) | an average of 2 year |
| Demographic characteristics, menopause | presence of menopause | It will be evaluated at the beginning of the study |
| Physical examination hand deformities, | subluxation, deviation, swan neck, button marrow deformities in hand examination | It will be evaluated at the beginning of the study |
| Physical examination hand deformities, | Subcutanea nodules | It will be evaluated at the beginning of the study |
| Lung involvement | Known pulmonary involvement, pulmonary function test and computed tomography results | an average of 2 year |
| Neurological involvement | Existing entrapment neuropathy, central involvement will be recorded | an average of 2 year |
| Laboratory- Urea | Urea levels from records | an average of 1 year |
| Laboratory- creatinine | Creatinine levels from records | an average of 1 year |
| Laboratory- liver function tests | Liver function tests from records | an average of 1 year |
| Laboratory-vitamin D | Vitamin D levels from records | an average of 1 year |
| Laboratory-hemoglobin | hemoglobin levels from records | an average of 1 year |
| Laboratory-leukocyte | leukocyte levels from records | an average of 1 year |
| Laboratory-platelet | platelet levels from records | an average of 1 year |
| Laboratory-Rheumatoid factor (RF) | Rheumatoid factor (RF) levels from records | It will be evaluated at the beginning |
| Laboratory-anticyclic citrullinated peptide (Anti CCP) | Anti CCP levels from records | It will be evaluated at the beginning |
| Laboratory-Lipid profile | LDL, HDL, Triglycerin, Cholesterol levels from records | an average of 2 year |
| Laboratory-hepatitis serology | HBs Ag, Anti HBs, HBc Ag, HBe Ag, Anti HBC levels from records, receiving antiviral treatment for hepatitis, hepatitis reactivation history will be questioned | an average of 2 year |
| Laboratory-HIV serology | Anti HIV levels from records | an average of 2 year |
| Imaging findings- X Ray | Hand wrist and pelvis X ray from records | It will be evaluated at the beginning |
| Imaging findings- magnetic resonance imaging | Sacroiliac joint MRI from records | It will be evaluated at the beginning |
| Imaging findings- Ultrasound | Hand ultrasound from records | It will be evaluated at the beginning |
| Imaging findings- Bone Mineral density | Bone Mineral density from records | an average of 2 year |
| Comorbidity | 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 | It will be evaluated at the beginning |
| Fall risk | The number of falls in the last year, the feeling of walking imbalance and the fear of falling and fracture history | It will be evaluated at the beginning |
| Evaluation of tuberculosis | PPD / quantiferon result and INH use before drug initiation | It will be evaluated at the beginning |
| Vaccination program | Applied hepatitis, tuberculosis, pneumonia, influenza vaccination programme | It will be evaluated at the beginning |
| Drugs | 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 | an average of 1 year |
| BASMI | Bath Ankylosing Spondylitis Metrology Index | an average of 2 year |
| MASES | Maastricht Ankylosing Spondylitis Enthesitis Score | an average of 1 year |
| PASI | The Psoriasis Area Severity Index | an average of 1 year |
| Turkish League Against Rheumatism |
| Principal Investigator |
| Özgür Akgül, AssocProf Dr | Turkish League Against Rheumatism | Principal Investigator |
| Erhan Çapkın, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Fatih Çay, AssocProf Dr | Turkish League Against Rheumatism | Principal Investigator |
| Remzi Çevik, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Tuncay Duruöz, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Feride Göğüş, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Gülcan Gürer, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Ayhan Kamanlı, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Meltem Alkan Melikoğlu, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Aylin Rezvani, AssocProf | Turkish League Against Rheumatism | Principal Investigator |
| İlhan Sezer, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| İsmihan Sunar, MD | Turkish League Against Rheumatism | Principal Investigator |
| İlker Yağcı, Prof Dr | Turkish League Against Rheumatism | Principal Investigator |
| Ankara University, Faculty of Medicine, Department of Rheumatology | Recruiting | Ankara | Turkey (Türkiye) |
|
| Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology | Recruiting | Ankara | Turkey (Türkiye) |
|
| Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Antalya | Turkey (Türkiye) |
|
| Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic | Recruiting | Antalya | Turkey (Türkiye) |
|
| Adnan Menderes University, Faculty of Medicine, Department of Rheumatology | Recruiting | Aydin | Turkey (Türkiye) |
|
| Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Diyarbakır | Turkey (Türkiye) |
|
| Istanbul Medipol University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Celal Bayar University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Manisa | Turkey (Türkiye) |
|
| Sakarya University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Sakarya | Turkey (Türkiye) |
|
| Atatürk University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Sivas | Turkey (Türkiye) |
|
| Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation | Recruiting | Trabzon | Turkey (Türkiye) |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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