An observational study in Rheumatoid Arthritis and Spondyloarthritis, sponsored by Turkish League Against Rheumatism. Status unknown at 14 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Turkish League Against Rheumatism · Observational
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
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Turkish League Against Rheumatism is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of patients followed in rheumatology and physical medicine and rehabilitation clinics in tertiary hospitals.
Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment
Exclusion Criteria:
Aged under 18 years old
Patients using Biological or Targeted Synthetic DMARDs
Other: There is no intervention in the study
There is no intervention in the study
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)
Time frame: 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)
Time frame: 24 weeks
Disease activity-SpA2
BASDAI score will be calculated
Time frame: 24 weeks
WPAI (Work Productivity and Activity Impairment Questionnaire)
Work Productivity and Activity Impairment Questionnaire:
Time frame: an average of 1 year
RAID (Rheumatoid Arthritis Impact of Disease Questionnaire)
Rheumatoid Arthritis Impact of Disease Questionnaire
Time frame: an average of 1 year
PSAID (Psoriatic Arthritis Impact of Disease Questionnaire)
Psoriatic Arthritis Impact of Disease Questionnaire
Time frame: an average of 1 year
DN-4 (Douleur Neuropathic 4 Questionnaire) questions)
Neuropathic pain questionnaire
Time frame: an average of 1 year
Cardiovascular disease risk
HDL and LDL cholesterol (mg/dl) levels from records , hypertension and diabetes history will be evaluated
Time frame: 1 year
SF-36 (Short form 36)
Quality of life questionnaire
Time frame: an average of 1 year
HAQ (Health assessment questionnaire)
Functional assessment, Questionnaire
Time frame: an average of 1 year
ASAS-HI (ASAS Health Index)
ASAS Health Index
Time frame: an average of 1 year
Fibromyalgia and central sensitization
Fibromyalgia criteria and central sensitization will be questioned
Time frame: an average of 2 year
Demographic characteristics -Age
Age, years
Time frame: It will be evaluated at the beginning of the study
Demographic characteristics -Gender
female/ male
Time frame: It will be evaluated at the beginning of the study
Demographic characteristics- smoking
Amount of smoking (packet-year)
Time frame: It will be evaluated at the beginning of the study
Demographic characteristics- alcohol use
How much and how often drink
Time frame: It will be evaluated at the beginning of the study
Demographic characteristics- education
Illiterate, literate, years of training
Time frame: 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
Time frame: It will be evaluated at the beginning of the study
Demographic characteristics, body mass index (kg/m2)
Height (cm)
Time frame: an average of 2 year
Demographic characteristics, body mass index (kg/m2)
Weight (kg)
Time frame: an average of 2 year
Demographic characteristics, menopause
presence of menopause
Time frame: It will be evaluated at the beginning of the study
Physical examination hand deformities,
subluxation, deviation, swan neck, button marrow deformities in hand examination
Time frame: It will be evaluated at the beginning of the study
Physical examination hand deformities,
Subcutanea nodules
Time frame: It will be evaluated at the beginning of the study
Lung involvement
Known pulmonary involvement, pulmonary function test and computed tomography results
Time frame: an average of 2 year
Neurological involvement
Existing entrapment neuropathy, central involvement will be recorded
Time frame: an average of 2 year
Laboratory- Urea
Urea levels from records
Time frame: an average of 1 year
Laboratory- creatinine
Creatinine levels from records
Time frame: an average of 1 year
Laboratory- liver function tests
Liver function tests from records
Time frame: an average of 1 year
Laboratory-vitamin D
Vitamin D levels from records
Time frame: an average of 1 year
Laboratory-hemoglobin
hemoglobin levels from records
Time frame: an average of 1 year
Laboratory-leukocyte
leukocyte levels from records
Time frame: an average of 1 year
Laboratory-platelet
platelet levels from records
Time frame: an average of 1 year
Laboratory-Rheumatoid factor (RF)
Rheumatoid factor (RF) levels from records
Time frame: It will be evaluated at the beginning
Laboratory-anticyclic citrullinated peptide (Anti CCP)
Anti CCP levels from records
Time frame: It will be evaluated at the beginning
Laboratory-Lipid profile
LDL, HDL, Triglycerin, Cholesterol levels from records
Time frame: 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
Time frame: an average of 2 year
Laboratory-HIV serology
Anti HIV levels from records
Time frame: an average of 2 year
Imaging findings- X Ray
Hand wrist and pelvis X ray from records
Time frame: It will be evaluated at the beginning
Imaging findings- magnetic resonance imaging
Sacroiliac joint MRI from records
Time frame: It will be evaluated at the beginning
Imaging findings- Ultrasound
Hand ultrasound from records
Time frame: It will be evaluated at the beginning
Imaging findings- Bone Mineral density
Bone Mineral density from records
Time frame: 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
Time frame: 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
Time frame: It will be evaluated at the beginning
Evaluation of tuberculosis
PPD / quantiferon result and INH use before drug initiation
Time frame: It will be evaluated at the beginning
Vaccination program
Applied hepatitis, tuberculosis, pneumonia, influenza vaccination programme
Time frame: 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
Time frame: an average of 1 year
BASMI
Bath Ankylosing Spondylitis Metrology Index
Time frame: an average of 2 year
MASES
Maastricht Ankylosing Spondylitis Enthesitis Score
Time frame: an average of 1 year
PASI
The Psoriasis Area Severity Index
Time frame: an average of 1 year
Plan to share: Yes — All of the collected data will be shared with investigators of the study
Supporting information: Study protocol, Icf
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Turkish League Against Rheumatism