Clinical Trials

"Please, for patient information and more details visit the study center iCCC Crohn Colitis Center"

Experience in Clinical Trials

Indication / EudraCT No. (if possible) / Comments Start (Year) End (Year) Phase AMG*
Crohn’s Disease
BI 695501 versus Humira® - Boehringer; BI 1297.4
EudraCT No. 2016-000612-14
2017 - III n
Crohn’s Disease
Filgotinib®, Gilead; GS-US-419-3895/6
EudraCT No. 2016-001415-20
2017 - III n
Ulcerative colitis
Filgotinib®, Gilead; GS-US-418-3898/9
EudraCT Nos. 2016-001392-78 and 2016-002765-58
2017 - IIb/3 n
Ulcerative colitis
Ozanimod®, Receptos/Celgene; RPC01-3101/2
EudraCT Nos. 2015-000319-41 and 2015-001600-64
2017 - III n
Crohn’s Disease
Mongersen (anti-SMAD7), Celgene; GED-0301;
EudraCT No. 2015-001963-37
2016 2017 III n
Ulcerative Colitis
Apremilast (CC10004) Celgene
EudraCT No. 2014-002981-64
2015 - II n
Non-interventional trial - Crohn’s & Ulcerative Colitis
Entyvio (vedolizumab); MLN-002-401; Takeda
2015 - - n
Crohn’s Disease
Galapagos NV/Belgium, specific JAK-1 Inhibitor; filgotinib GLPG0634-CL-211
EudraCT No. 2013-002857-32
2015 2015 II n
Ulcerative Colitis
Dr. Falk Pharma (PC complex) PCG4/UCR
EudraCT No. 2013-001205-84
2014 - III n
Ulcerative Colitis
Dr. Falk Pharma (PC complex) PCG2/UCA
EudraCT No. 2012-003702-27
2014 2017 III n
Crohn’s Disease
Parexel, Centocor, Stellara/Ustekinumab 3003
EudraCT No. 2010-022760-12
2013 - III n
Ulcerative Colitis
Parexel, OLOKIZUMAB
EudraCT No. 2011-002517-11
2011 - II n
Crohn’s Disease
Parexel, Centocor, Stellara/Ustekinumab 3002
EudraCT No. 2010-022759-42
2011 - III n
Crohn’s Disease
Parexel, Centocor, Stellara/Ustekinumab 3001
EudraCT No. 2010-022758-18
2010 2012 III n
Crohn’s Disease
SHIELD (Iron Therapeutics) - AEGIS Prot.No. ST-10-01-301/2
EudraCT No. 2010-023589-39
2011 2014 III n
Ulcerative Colitis
Novartis CKRP203 A2201
EudraCT No. 2010-019970-33
2010 2013 II n
Rheumatoid Arthritis
Research Study with 50 Patients (Ann Rheum Dis. 2007; 66(9):1151), Frankfurt
2004 2007 (IV) n
Kidney Transplantation
FK506 (Sandoz) (was retracted), Frankfurt, Nürnberg
2003 2004 IV n
Kidney Transplantation
Research Study with 69 patients (J Am Soc Nephrol. 2005;16(6):1849-58), Frankfurt
2002 2005 (IV) a
Osteoporosis
1-38 Parathyroid Hormone, Bissendorf Peptides, Hannover
1987 1987 II a
* a = Initiation of trial BEFORE "12. AMG Novelle" (Change of German Law) August 2004
   n = Initiation of trial AFTER "12. AMG Novelle"

Relevant Qualification/Training

Title / Training Provider Date
Klinischer Prüfarzt, GCP Certificate, GCP-Service Int. Bremen
Dec 2017
Klinischer Prüfarzt, GCP Certificate, GCP-Service Int. Bremen Jan, 2015
Klinischer Prüfarzt, GCP Certificate, DGPharMed, Berlin Apr, 2011
Facharzt Klinische Pharmakologie 2004
Statistische Auswertung Klinischer Prüfungen – Prof. Zepp, KKS, Mainz Feb, 2002

Membership in Medical/Scientific Societies

Society Since
Deutsche Gesellschaft für Klinische und Allgemeine Pharmakologie und Toxikologie (DGPT) 1991
Deutsche / Amerikanische Gesellschaft für Nephrologie (GfN, ASN) 1991-2005
Deutsche / American Gesellschaft für Immunologie (DGfI; AAI) 1988

H. H. Radeke - Copyright 2017