Clinical trial NCT04139954: Observational Registry of Patients With Rheumatoid Arthritis /Spondyloarthritis Using Biological or Targeted Synthetic DMARDs
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Lead sponsor: Turkish League Against Rheumatism
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients followed in rheumatology and physical medicine and rehabilitation clinics in tertiary hospitals.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Aged under 18 years old

Primary outcomes:
measure: Disease activity RA
timeFrame: 24 weeks
measure: Disease activity- SpA1
timeFrame: 24 weeks
measure: Disease activity-SpA2
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
measure: WPAI (Work Productivity and Activity Impairment Questionnaire)
timeFrame: an average of 1 year
measure: RAID (Rheumatoid Arthritis Impact of Disease Questionnaire)
timeFrame: an average of 1 year
measure: PSAID (Psoriatic Arthritis Impact of Disease Questionnaire)
timeFrame: an average of 1 year
measure: DN-4 (Douleur Neuropathic 4 Questionnaire) questions)
timeFrame: an average of 1 year
measure: Cardiovascular disease risk
timeFrame: 1 year
measure: SF-36 (Short form 36)
timeFrame: an average of 1 year
measure: HAQ (Health assessment questionnaire)
timeFrame: an average of 1 year
measure: ASAS-HI (ASAS Health Index)
timeFrame: an average of 1 year
measure: Fibromyalgia and central sensitization
timeFrame: an average of 2 year
measure: Demographic characteristics -Age
timeFrame: It will be evaluated at the beginning of the study
measure: Demographic characteristics -Gender
timeFrame: It will be evaluated at the beginning of the study
measure: Demographic characteristics- smoking
timeFrame: It will be evaluated at the beginning of the study
measure: Demographic characteristics- alcohol use
timeFrame: It will be evaluated at the beginning of the study
measure: Demographic characteristics- education
timeFrame: It will be evaluated at the beginning of the study
measure: Demographic characteristics- fertility and pregnancy history
timeFrame: It will be evaluated at the beginning of the study
measure: Demographic characteristics, body mass index (kg/m2)
timeFrame: an average of 2 year
measure: Demographic characteristics, body mass index (kg/m2)
timeFrame: an average of 2 year
measure: Demographic characteristics, menopause
timeFrame: It will be evaluated at the beginning of the study
measure: Physical examination hand deformities,
timeFrame: It will be evaluated at the beginning of the study
measure: Physical examination hand deformities,
timeFrame: It will be evaluated at the beginning of the study
measure: Lung involvement
timeFrame: an average of 2 year
measure: Neurological involvement
timeFrame: an average of 2 year
measure: Laboratory- Urea
timeFrame: an average of 1 year
measure: Laboratory- creatinine
timeFrame: an average of 1 year
measure: Laboratory- liver function tests
timeFrame: an average of 1 year
measure: Laboratory-vitamin D
timeFrame: an average of 1 year
measure: Laboratory-hemoglobin
timeFrame: an average of 1 year
measure: Laboratory-leukocyte
timeFrame: an average of 1 year
measure: Laboratory-platelet
timeFrame: an average of 1 year
measure: Laboratory-Rheumatoid factor (RF)
timeFrame: It will be evaluated at the beginning
measure: Laboratory-anticyclic citrullinated peptide (Anti CCP)
timeFrame: It will be evaluated at the beginning
measure: Laboratory-Lipid profile
timeFrame: an average of 2 year
measure: Laboratory-hepatitis serology
timeFrame: an average of 2 year
measure: Laboratory-HIV serology
timeFrame: an average of 2 year
measure: Imaging findings- X Ray
timeFrame: It will be evaluated at the beginning
measure: Imaging findings- magnetic resonance imaging
timeFrame: It will be evaluated at the beginning
measure: Imaging findings- Ultrasound
timeFrame: It will be evaluated at the beginning
measure: Imaging findings- Bone Mineral density
timeFrame: an average of 2 year
measure: Comorbidity
timeFrame: It will be evaluated at the beginning
measure: Fall risk
timeFrame: It will be evaluated at the beginning
measure: Evaluation of tuberculosis
timeFrame: It will be evaluated at the beginning
measure: Vaccination program
timeFrame: It will be evaluated at the beginning
measure: Drugs
timeFrame: an average of 1 year
measure: BASMI
timeFrame: an average of 2 year
measure: MASES
timeFrame: an average of 1 year
measure: PASI
timeFrame: an average of 1 year
Locations:
city: Ankara
country: Turkey
facility: Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation
city: Ankara
country: Turkey
facility: Ankara University, Faculty of Medicine, Department of Rheumatology
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic
city: Aydın
country: Turkey
facility: Adnan Menderes University, Faculty of Medicine, Department of Rheumatology
city: Diyarbakır
country: Turkey
facility: Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Faculty of Medicine Department of Physical Medicine and Rehabilitation
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology
city: Istanbul
country: Turkey
facility: Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation
city: Manisa
country: Turkey
facility: Celal Bayar University Faculty of Medicine Department of Physical Medicine and Rehabilitation
city: Sakarya
country: Turkey
facility: Sakarya University Faculty of Medicine Department of Physical Medicine and Rehabilitation
city: Sivas
country: Turkey
facility: Atatürk University Faculty of Medicine Department of Physical Medicine and Rehabilitation
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Turkish League Against Rheumatism
name: Hatice Bodur, Prof Dr
role: STUDY_DIRECTOR
affiliation: Turkish League Against Rheumatism
name: Şebnem Ataman, Prof Dr
role: STUDY_DIRECTOR
affiliation: Turkish League Against Rheumatism
name: Fatma G Yurdakul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Özgür Akgül, AssocProf Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Erhan Çapkın, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Fatih Çay, AssocProf Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Remzi Çevik, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Tuncay Duruöz, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Feride Göğüş, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Gülcan Gürer, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Ayhan Kamanlı, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Meltem Alkan Melikoğlu, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: Aylin Rezvani, AssocProf
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: İlhan Sezer, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: İsmihan Sunar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkish League Against Rheumatism
name: İlker Yağcı, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.