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

Rheumatoid Arthritis Clinical Trial

— BioSTaR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139954
• Other study ID #: TRASD
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2019
• Source: Turkish League Against Rheumatism
• Contact: Fatma G Yurdakul, MD
• Phone: +905059254214
• Email: fatmagulonder[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Aged under 18 years old

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

Intervention

Other:
• There is no intervention in the study
There is no intervention in the study

Locations

Country	Name	City	State
Turkey	Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation	Ankara
Turkey	Ankara University, Faculty of Medicine, Department of Rheumatology	Ankara
Turkey	Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology	Ankara
Turkey	Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation	Antalya
Turkey	Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic	Antalya
Turkey	Adnan Menderes University, Faculty of Medicine, Department of Rheumatology	Aydin
Turkey	Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation	Diyarbakir
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	Istanbul
Turkey	Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology	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	Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Turkish League Against Rheumatism

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WPAI (Work Productivity and Activity Impairment Questionnaire)	Work Productivity and Activity Impairment Questionnaire:	an average of 1 year
Other	RAID (Rheumatoid Arthritis Impact of Disease Questionnaire)	Rheumatoid Arthritis Impact of Disease Questionnaire	an average of 1 year
Other	PSAID (Psoriatic Arthritis Impact of Disease Questionnaire)	Psoriatic Arthritis Impact of Disease Questionnaire	an average of 1 year
Other	DN-4 (Douleur Neuropathic 4 Questionnaire) questions)	Neuropathic pain questionnaire	an average of 1 year
Other	Cardiovascular disease risk	HDL and LDL cholesterol (mg/dl) levels from records , hypertension and diabetes history will be evaluated	1 year
Other	SF-36 (Short form 36)	Quality of life questionnaire	an average of 1 year
Other	HAQ (Health assessment questionnaire)	Functional assessment, Questionnaire	an average of 1 year
Other	ASAS-HI (ASAS Health Index)	ASAS Health Index	an average of 1 year
Other	Fibromyalgia and central sensitization	Fibromyalgia criteria and central sensitization will be questioned	an average of 2 year
Other	Demographic characteristics -Age	Age, years	It will be evaluated at the beginning of the study
Other	Demographic characteristics -Gender	female/ male	It will be evaluated at the beginning of the study
Other	Demographic characteristics- smoking	Amount of smoking (packet-year)	It will be evaluated at the beginning of the study
Other	Demographic characteristics- alcohol use	How much and how often drink	It will be evaluated at the beginning of the study
Other	Demographic characteristics- education	Illiterate, literate, years of training	It will be evaluated at the beginning of the study
Other	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
Other	Demographic characteristics, body mass index (kg/m2)	Height (cm)	an average of 2 year
Other	Demographic characteristics, body mass index (kg/m2)	Weight (kg)	an average of 2 year
Other	Demographic characteristics, menopause	presence of menopause	It will be evaluated at the beginning of the study
Other	Physical examination hand deformities,	subluxation, deviation, swan neck, button marrow deformities in hand examination	It will be evaluated at the beginning of the study
Other	Physical examination hand deformities,	Subcutanea nodules	It will be evaluated at the beginning of the study
Other	Lung involvement	Known pulmonary involvement, pulmonary function test and computed tomography results	an average of 2 year
Other	Neurological involvement	Existing entrapment neuropathy, central involvement will be recorded	an average of 2 year
Other	Laboratory- Urea	Urea levels from records	an average of 1 year
Other	Laboratory- creatinine	Creatinine levels from records	an average of 1 year
Other	Laboratory- liver function tests	Liver function tests from records	an average of 1 year
Other	Laboratory-vitamin D	Vitamin D levels from records	an average of 1 year
Other	Laboratory-hemoglobin	hemoglobin levels from records	an average of 1 year
Other	Laboratory-leukocyte	leukocyte levels from records	an average of 1 year
Other	Laboratory-platelet	platelet levels from records	an average of 1 year
Other	Laboratory-Rheumatoid factor (RF)	Rheumatoid factor (RF) levels from records	It will be evaluated at the beginning
Other	Laboratory-anticyclic citrullinated peptide (Anti CCP)	Anti CCP levels from records	It will be evaluated at the beginning
Other	Laboratory-Lipid profile	LDL, HDL, Triglycerin, Cholesterol levels from records	an average of 2 year
Other	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
Other	Laboratory-HIV serology	Anti HIV levels from records	an average of 2 year
Other	Imaging findings- X Ray	Hand wrist and pelvis X ray from records	It will be evaluated at the beginning
Other	Imaging findings- magnetic resonance imaging	Sacroiliac joint MRI from records	It will be evaluated at the beginning
Other	Imaging findings- Ultrasound	Hand ultrasound from records	It will be evaluated at the beginning
Other	Imaging findings- Bone Mineral density	Bone Mineral density from records	an average of 2 year
Other	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
Other	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
Other	Evaluation of tuberculosis	PPD / quantiferon result and INH use before drug initiation	It will be evaluated at the beginning
Other	Vaccination program	Applied hepatitis, tuberculosis, pneumonia, influenza vaccination programme	It will be evaluated at the beginning
Other	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
Other	BASMI	Bath Ankylosing Spondylitis Metrology Index	an average of 2 year
Other	MASES	Maastricht Ankylosing Spondylitis Enthesitis Score	an average of 1 year
Other	PASI	The Psoriasis Area Severity Index	an average of 1 year
Primary	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
Primary	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
Primary	Disease activity-SpA2	BASDAI score will be calculated	24 weeks