Wissenschaftliche Studien

Prof. Dr. med. Alexander Pfeil

Sektion Rheumatologie/Osteologie,
Facharzt für Innere Medizin/Rheumatologie; Osteologe DVO, Notfallmedizin, Fachkunde Leitender Notarzt, Immunologe,
Leiter Sektion und Rheumazentrum (nach GBA-Kriterien)

Web

Dr. med. Carolin Pflug

Sektion Rheumatologie/Osteologie,
Studienleiterin,
Oberärztin

*Indikationsbereich*	*EudraCT-Nr.*	*Phase*	*Studientitel*	*Protokollnummer*
Cutaneous Systemic Sclerosis	2022- 500332-11-00 NCT05559580	II	A Phase II, randomised, placebo-controlled, double-blind, parallel-group efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with early progressive diffuse cutaneous systemic sclerosis	1366-0031 (VITALISScE)
GCA	2021- 002622-24	IIIb	A randomized, parallel-group, double-blind, placebo-controlled, multicenter trial to investigate the efficacy and safety of subcutaneously administered secukinumab in patients with new-onset of giant cell arteritis (GCA) who are in clinical remission and eligible for treatment with glucocorticoid-monotheraphy (GigAINt)	CAIN457R1DE01 (GigAINt)
SLE	2017- 005026-37	III	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	I4V-MC-JAHZ
GCA	2018- 001003-36	II	A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis	KPL-301-C001
EGPA	2014- 003162-25	III	Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)	MEA116841
SLE	2014- 004632-19	III	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	D3461C00004 (Tulip II SLE)
GCA	2015- 001758-14	III	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis	201677 (Sirresta)
SLE	2016- 000625-39	III	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	D3461C00009 (Tulip SLE LTE)
GCA	2011- 006022-25	III	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	WA28119 (GiACTA)
Ankylosing Spondylitis	2013- 001090-24	III	A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis	CAIN457F2314
EPGA	2012- 004385-17	III	A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy.	MEA115921
Ankylosing Spondylitis	2010- 024529-18	III	A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis	CAIN457F2305 (MEASURE-1)