Clinical Trials
Experience in Clinical Trials |
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| Indication / EudraCT No. (if possible) / Comments | Start (Year) | End (Year) | Phase | AMG* |
|---|---|---|---|---|
| ANAEMIA in IBD Hypophosphatemia in relation to repeated treatment courses of iron isomaltoside and ferric carboxymaltose - Pharmacosmos Protocol No. P-Monofer-IBD-03 EudraCT No. 2017-002452-87 |
2018 | - | III | n |
| CROHN’S DISEASE Ustekinumab®, Induction and Maintenance of Mucosal Healing (MUCUS) - Charité – Universitätsmedizin Berlin, Gastroenterologie, Protocol No. MUCUS EudraCT No. 2017-005151-83 |
2018 | - | III | n |
| CROHN’S DISEASE Oral OZANIMOD®, Open Label Extension study (Yellowstone) - Celgene Protocol No. RPC01-3204 EudraCT No. 2017-004295-55 |
2018 | - | III | n |
| CROHN’S DISEASE Oral OZANIMOD®, Maintenance Therapy study (Yellowstone) - Celgene Protocol No. RPC01-3203 EudraCT No. 2017-004294-14 |
2018 | - | III | n |
| CROHN’S DISEASE Oral OZANIMOD®, Induction study (Yellowstone) - Celgene Protocol No. RPC01-3201 EudraCT No. 2017-004292-31 |
2018 | - | III | n |
| Ulcerative Colitis Filgotinib®, Gilead-Fertility Study (MANTA) GS-US-418-4279 EudraCT No. 2017-000402-38 |
2018 | - | III | n |
| 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 |
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* a = Initiation of trial BEFORE "12. AMG Novelle" (Change of German Law) August 2004 n = Initiation of trial AFTER "12. AMG Novelle" |
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Relevant Qualification/Training |
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| Title / Training Provider | Date | |||
|---|---|---|---|---|
| Klinischer Prüfarzt, GCP Certificate, GCP-Service Int. Bremen | Dec 2017 |
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| 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 |
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| 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 | |||