Rheumatoid ArthritisBioSTaRNCT04139954
Observational Registry of Patients With Rheumatoid Arthritis /Spondyloarthritis Using Biological or Targeted Synthetic DMARDs
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Turkish League Against Rheumatism at 14 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis
- How many people
- 1,400 participants
- Where
- 14 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients followed in rheumatology and physical medicine and rehabilitation clinics in tertiary hospitals.
Who may be able to join
- Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment
Who cannot join
- Aged under 18 years old
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Turkey (Türkiye)14 sites, 14 recruiting
- Recruiting
Ankara Numune Training and Education Hospital, Department of Physical Medicine and Rehabilitation
Ankara
Hatice Bodur, Prof Dr, +905054848496, haticebodur@gmail.com
Fatma G Yurdakul, MD
- Recruiting
Ankara University, Faculty of Medicine, Department of Rheumatology
Ankara
Şebnem Ataman, Prof Dr, +905322711076, ataman.sebnem@gmail.com
İsmihan Sunar, MD
- Recruiting
Gazi University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Department of Rheumatology
Ankara
Feride Göğüş, Prof Dr, 05322501164, feride_g@yahoo.com
- Recruiting
Akdeniz University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Antalya
İlhan Sezer, 05055402273, drilhan@yahoo.com
- Recruiting
Antalya Training and Research Hospital Physical Medicine and Rehabilitation Clinic
Antalya
Fatih Çay, Assoc Prof, 05322509147, drfatihcay@gmail.com
- Recruiting
Adnan Menderes University, Faculty of Medicine, Department of Rheumatology
Aydin
Gülcan Gürer, Prof Dr, 05334595107, gurergulcan@yahoo.com.tr
- Recruiting
Dicle University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Diyarbakır
Remzi Çevik, Prof Dr, 05322282856, ftremzi@hotmail.com
- Recruiting
Istanbul Medipol University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Istanbul
Aylin Rezvani, Assoc Prof, 05336684078, rezvani.aylin@gmail.com
- Recruiting
Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Department of Rheumatology
Istanbul
Tuncay Duruöz, Prof Dr, 05335121548, tuncayduruoz@gmail.com
- Recruiting
Marmara University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Istanbul
İlker Yağcı, Prof Dr, 05334597155, drilkery@yahoo.com
- Recruiting
Celal Bayar University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Manisa
Özgür Akgül, Assoc Prof, 05515986299, ozgur.akgul.md@gmail.com
- Recruiting
Sakarya University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Sakarya
Ayhan Kamanlı, Prof Dr, 05387046906, akamanli@hotmail.com
- Recruiting
Atatürk University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Sivas
Meltem Alkan Melikoğlu, Prof Dr, 05326934469, mamelikoglu@gmail.com
- Recruiting
Karadeniz Technical University Faculty of Medicine Department of Physical Medicine and Rehabilitation
Trabzon
Erhan Çapkın, Prof Dr, 05052344258, drcapkin@yahoo.com
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis
- Being tested
- There is no intervention in the study
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in the studyOther
There is no intervention in the study
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis and Spondyloarthritis | Patients using Biological or Targeted Synthetic DMARDs Receives: Other: There is no intervention in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 24 weeks
Disease activity-SpA2
BASDAI score will be calculated
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Feb 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish League Against Rheumatism
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gül Yurdakul, Turkish League Against Rheumatism
- Investigators
- Hatice Bodur, Prof Dr, Study director, Turkish League Against RheumatismŞebnem Ataman, Prof Dr, Study director, Turkish League Against RheumatismFatma G Yurdakul, MD, Principal investigator, Turkish League Against RheumatismÖzgür Akgül, AssocProf Dr, Principal investigator, Turkish League Against RheumatismErhan Çapkın, Prof Dr, Principal investigator, Turkish League Against RheumatismFatih Çay, AssocProf Dr, Principal investigator, Turkish League Against RheumatismRemzi Çevik, Prof Dr, Principal investigator, Turkish League Against RheumatismTuncay Duruöz, Prof Dr, Principal investigator, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139954
- Sponsor's protocol ID
- TRASD
- Acronym
- BioSTaR
- Status last verified
- Oct 2019
- First submitted
- 1 Sep 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the collected data will be shared with investigators of the study
Publications
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.
PubMed 35353263
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04139954
- Acronym / sponsor ID
- BioSTaR / TRASD
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Turkish League Against RheumatismUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis and Spondyloarthritis | – | Other: There is no intervention in the studyPatients using Biological or Targeted Synthetic DMARDs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients followed in rheumatology and physical medicine and rehabilitation clinics in tertiary hospitals.
Key inclusion criteria (1 listed)
- Clinical diagnosis with rheumatoid arthritis or spondyloarthritis Receiving biological or targeted synthetic DMARD treatment
Key exclusion criteria (1 listed)
- Aged under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention in the studyThere is no intervention in the study | Other | Rheumatoid arthritis and Spondyloarthritis |
Primary outcome
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)
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)
Disease activity-SpA2
Time frame: 24 weeks
BASDAI score will be calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Derived from this study: PubMed 35353263Bodur 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.
- Individual participant dataSharing planned: Yes. All of the collected data will be shared with investigators of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice Bodur, Prof Dr study director
Turkish League Against Rheumatism
Şebnem Ataman, Prof Dr study director
Turkish League Against Rheumatism
Fatma G Yurdakul, MD principal investigator
Turkish League Against Rheumatism
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Turkish League Against Rheumatism at 14 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma G Yurdakul, MD (+905059254214, fatmagulonder@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity RA (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.