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NCT04139954: BioSTaR
Observational Registry of Patients With Rheumatoid Arthritis /Spondyloarthritis Using Biological or Targeted Synthetic DMARDs
trial testing There is no intervention in the study in Rheumatoid Arthritis in 1,400 participants. Status unknown.
1 March 2020
Quick facts
| Lead sponsor | Turkish League Against Rheumatism |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,400 |
| Start date | 1 February 2019 |
| Primary completion | 1 March 2020 |
| Estimated completion | 1 March 2024 |
| Sites | 14 locations across Turkey (Türkiye) |
Drugs / interventions tested
- There is no intervention in the study
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Spondyloarthritis — all drugs for Spondyloarthritis →
Sponsor
Turkish League Against Rheumatism
Who can join
18 and older, any sex, with Rheumatoid Arthritis or Spondyloarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. The study is observational and there is no expected risk since no intervention is planned.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Bodur H, Yurdakul FG, Ataman S, Cay HF, et al · · 2022 · cited 3× · PMID 35353263 · DOI 10.1007/s10067-022-06145-8
Verify or expand the search:
- PubMed search for NCT04139954
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Turkish League Against Rheumatism trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04139954 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Turkish League Against Rheumatism
- Last refreshed: 29 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04139954.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing