Last updated on: 16/08/2017
1. Contact details
Name of data sourceBiologika in der Kinderrheumatologie
Name under which the data source should be displayed in the inventory (e.g short name if one exists)BIKER
Name of organisation
1) Department/research group
2) Organisation/affiliationBIKER
Administrative Contact
Title Professor
Last name Horneff
First name Gerd
Address line 1Arnold-Janssen-Strasse 29
Address line 2
Address line 3
CitySankt Augustin
Postcode53757
CountryGermany
Scientific Contact
Title Mrs
Last name Eising
First name Kristina
Address line 1Arnold-Janssen-Strasse 29
Address line 2
Address line 3
CitySankt Augustin
Postcode53757
CountryGermany
Alternative Contact
Title Dr
Last name Klein
First name Ariane
Address line 1Arnold-Janssen-Strasse 29
Address line 2
Address line 3
CitySankt Augustin
Postcode53757
CountryGermany
2. Description/category
Disease/case registry
Exposure registry
Prospective studies database
3.1 Coverage of licensed medicinal products
Licensed Medicinal Product
Comments
Anti-rheumatic drugs
3.2 ATC code (5th level)
Yes
3.3 Other product dictionaries
No
3.4 Recording of indication for use
Yes
Is a coding dictionary being used? MedDra
4. Coverage of events
Event
Dictionary
Dictionary details
Adverse events (for pharmacovigilance databases)
Yes
MedDra
Symptoms/signs
No
Specialist diagnosis
Yes
MedDra
Discharge diagnosis
Yes
MedDra
Laboratory values
No
Death
No
Procedures
No
Overdoses
No
Teratogenic events
Yes
MedDra
5. Year of establishment
2001
6. Geographical origin of data
EEA/EFTA countries
Austria
Germany
7. Demographical extent of data collection
Nation-wide
8. Age groups
17 years and under [Paediatrics]
infants and toddlers (28 days to 23 months)
children (2 to 11 years)
adolescents (12 to 17 years)
9. Size of the source/catchment population
15,000
10 a. Total (cumulative) number of persons with actual data
5,000
10 b. Number of persons with active data collection in past calendar year
1,500
11. Possibility to obtain additional information on the patient
a) Clinical information from treating physician?
Yes
b) Questionnaire data from the patient?
Yes
c) Genetic information or samples?
No
12. Possibility of links to other sources of data
No
13. Written policy governing data access
Yes
14. Committee to evaluate requests for data access
Yes
15. Charge/fee for data access
No
16. Selected publications of the last 5 calendar years using data from this data source
ReferenceLink to web-publication
Comparison of treatment response, remission rate and drug adherence in polyarticular juvenile idiopathic arthritis patients treated with etanercept, adalimumab or tocilizumab.
Horneff G, Klein A, Klotsche J, Minden K, Huppertz HI, Weller-Heinemann F, Kuemmerle-Deschner J, Haas JP, Hospach A.
Arthritis Res Ther. 2016 Nov 24;18(1):272.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5122012/
Update on malignancies in children with juvenile idiopathic arthritis in the German BIKER Registry.
Horneff G, Klein A, Oommen PT, Hospach A, Foeldvari I, Feddersen I, Minden K.
Clin Exp Rheumatol. 2016 Sep 8https://www.ncbi.nlm.nih.gov/pubmed/27749226
Outcome and trends in treatment of systemic juvenile idiopathic arthritis in the German National Pediatric Rheumatological Database from 2000 to 2013.
Klotsche J, Raab A, Niewerth M, Sengler C, Ganser G, Kallinich T, Niehues T, Hufnagel M, Thon A, Hospach T, Horneff G, Minden K.
Arthritis Rheumatol. 2016 Jun 22. doi: 10.1002/art.39796.https://www.ncbi.nlm.nih.gov/pubmed/27332999
Safety of biologic therapies for the treatment of juvenile idiopathic arthritis.
Horneff G.
Expert Opin Drug Saf. 2015 Jul;14(7):1111-26. doi: 10.1517/14740338.2015.1042453. Reviewhttps://www.ncbi.nlm.nih.gov/pubmed/26084637
Long-term safety of etanercept and adalimumab compared to methotrexate in patients with juvenile idiopathic arthritis (JIA).
Klotsche J, Niewerth M, Haas JP, Huppertz HI, Zink A, Horneff G, Minden K.
Ann Rheum Dis. 2015 Apr 29. pii: annrheumdis-2014-206747. doi: 10.1136/annrheumdis-annrheumdis-2014-206747https://www.ncbi.nlm.nih.gov/pubmed/25926155
