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

October 25, 2019 updated by: Fatma Gül Yurdakul, Turkish League Against Rheumatism

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation
        • Contact:
        • Principal Investigator:
          • Fatma G Yurdakul, MD
      • Ankara, Turkey
        • Recruiting
        • Ankara University, Faculty of Medicine, Department of Rheumatology
        • Contact:
        • Principal Investigator:
          • İsmihan Sunar, MD
      • Ankara, Turkey
        • Recruiting
        • Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology
        • Contact:
      • Antalya, Turkey
        • Recruiting
        • Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
      • Antalya, Turkey
        • Recruiting
        • Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic
        • Contact:
      • Aydın, Turkey
        • Recruiting
        • Adnan Menderes University, Faculty of Medicine, Department of Rheumatology
        • Contact:
      • Diyarbakır, Turkey
        • Recruiting
        • Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
      • Istanbul, Turkey
        • Recruiting
        • Istanbul Medipol University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
      • Istanbul, Turkey
        • Recruiting
        • Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology
        • Contact:
      • Istanbul, Turkey
        • Recruiting
        • Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
      • Manisa, Turkey
        • Recruiting
        • Celal Bayar University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
      • Sakarya, Turkey
        • Recruiting
        • Sakarya University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
      • Sivas, Turkey
        • Recruiting
        • Atatürk University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
      • Trabzon, Turkey
        • Recruiting
        • Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Aged under 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid arthritis and Spondyloarthritis
Patients using Biological or Targeted Synthetic DMARDs
Other: There is no intervention in the study
There is no intervention in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity RA
Time Frame: 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)
24 weeks
Disease activity- SpA1
Time Frame: 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)
24 weeks
Disease activity-SpA2
Time Frame: 24 weeks
BASDAI score will be calculated
24 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish League Against Rheumatism

Investigators

  • Study Director: Hatice Bodur, Prof Dr, Turkish League Against Rheumatism
  • Study Director: Şebnem Ataman, Prof Dr, Turkish League Against Rheumatism
  • Principal Investigator: Fatma G Yurdakul, MD, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2024

Study Registration Dates

First Submitted

September 1, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (ACTUAL)

October 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRASD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the collected data will be shared with investigators of the study

IPD Sharing Time Frame

After the end of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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