Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants

PHASE4CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

March 29, 2016

Primary Completion Date

February 9, 2018

Study Completion Date

February 9, 2018

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Placebo matched to prednisone

Participants will receive placebo matched to prednisone orally for 24 weeks.

DRUG

Prednisone

Participants will receive prednisone either at a constant dose of 5 mg/day, or 5 mg/day with 1 mg decrements every 4 weeks orally for 24 weeks.

BIOLOGICAL

Tocilizumab

Participants will receive tocilizumab at a dose of 162 mg once a week subcutaneously for 24 weeks.

Trial Locations (39)

4000

Hopital Farhat Hached; Service Rhumatologie, Sousse

10117

Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie, Berlin

11000

Institute of Rheumatology, Belgrade

Military Medical Academy; Clinic of Rheumatology, Belgrade

14059

SchlossPark-Klinik Berlin; Int. Med. II, Rheum. Osteo, Berlin

18205

Institute of Rheumatology and Cardiovascular Diseases; Rheumatology, Niška Banja

20246

Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Med.Klinik III, Hamburg

21000

Clinical Center of Vojvodina, Novi Sad

Special hospital for rheumatic diseases Novi Sad, Novi Sad

22147

Praxis Dr.med. Maria Höhle, Hamburg

27100

Irccs Policlinico San Matteo; Reumatologia Adulti, Pavia

31059

Hopital Purpan; Rhumatologie, Toulouse

33076

Hopital Pellegrin; Rhumatologie, Bordeaux

39104

Rheumatologische Facharztpraxis Maren Sieburg, Magdeburg

39120

SMO.MD GmbH, Zentrum für klinische Studien, Magdeburg

40878

Rheumazentrum Ratingen - Studienambulanz, Ratingen

42100

Arcispedale Santa Maria Nuova; Reumatologia, Reggio Emilia

45067

Hopital de La Source, Orléans

49074

Rheumapraxis an der Hase, Osnabrück

50139

Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia, Florence

50924

Klinik der Uni zu Köln; Klinik für Innere Medizin, Cologne

52064

Praxis Dr. med. Reiner Kurthen, Aachen

53474

Rheumatologische Gemeinschaftspraxis Grafschaft, Dr. med. Dorothea Pick, Dr. med. Christopher Amberg, Bad Neuenahr-Ahrweiler

67098

Hopital Hautepierre; Rhumatologie, Strasbourg

69120

Rheumapraxis PD Dr.med. Bernhard Heilig, Heidelberg

70178

Rheumatologische Schwerpunktpraxis am Feuersee, Stuttgart

75679

Hopital Cochin; Rhumatologie B, Paris

80336

Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV, München

81541

Praxiszentrum St. Bonifatius, München

91056

Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w., Erlangen

93077

Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie, Bad Abbach

97080

Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie, Würzburg

99096

MVZ Ambulantes Rheumazentrum, Erfurt

195067

"SBEI of HPE Northwestern State Medical University n.a. I.I.Mechnikov of MoH of RF", Saint Petersburg

450005

Republican clinical hospital named after G.G. Kuvatov, Ufa

614000

Perm Regional Clinical Hospital, Perm

630117

FSBI Scientific Research Institute of Clinical and Experimental Lymphology of SB of RAMS, Novosibirsk

690105

City Clinical Hospital # 2, Vladivostok

01109

Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi, Dresden

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02573012 - Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants | Biotech Hunter | Biotech Hunter