This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with giant cell
arteritis. Patients will be randomized to receive either RoActemra/Actemra 162 mg
subcutaneously weekly or every 2 weeks or placebo for 52 weeks, with tapering oral daily
doses of prednisone. After Week 52, patients in remission will stop study treatment and
enter long-term follow-up, whereas patients with disease activity or flares will receive
open-label RoActemra/Actemra 162 mg subcutaneously weekly for a maximum period of 104 weeks
at the discretion of the investigator. Anticipated time on study is 39 months.
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Diagnosis of giant cell arteritis classified according to the following criteria:
- Age >/= 50 years
- History of ESR >/= 50 mm/hour
- and at least one of the following:
- Unequivocal cranial symptoms of giant cell arteritis
- Symptoms of polymyalgia rheumatica
- and at least one of the following
- Temporal artery biopsy revealing features of giant cell arteritis
- Evidence of large-vessel vasculitis
- New onset active disease (diagnosis within 6 weeks of baseline) or refractory active
disease (diagnosis > 6 weeks before baseline and previous treatment with >/= 40
mg/day prednisone (or equivalent) for at least 2 consecutive weeks at any time);
active disease defined as presence of clinical signs and symptoms and ESR >/= 30
mm/hour or CRP >/= 1 mg/dl within 6 weeks of baseline
Exclusion Criteria:
- Recent or incoming major surgery
- Organ transplantation recipient (except corneas within 3 months prior to baseline
visit)
- Major ischemic event, unrelated to giant cell arteritis, within 12 weeks of screening
- Prior treatment with any of the following:
- Investigational agent within 12 weeks (or 5 half-lives of the investigational
drug, whichever is longer) of screening visit
- Cell-depleting agents (e. g. anti CD 20)
- Tocilizumab
- Tofacitinib
- Alkylating agents including CYC within 6 months of baseline
- HCQ, CsA, AZA, or MMF within 4 weeks of baseline
- Tumor necrosis factor inhibitors within 2-8 weeks of baseline
- Anakinra within 1 week of baseline
- Corticosteroids for conditions other than GCA
- IV corticosteroids within 6 weeks of baseline
- History of severe allergic reactions to monoclonal antibodies
- Evidence of serious uncontrolled concomitant disease (e. g. cardiovascular,
respiratory, renal, endocrine)
- Current liver disease that could interfere with the trial as determined by the
investigator
- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract
condition that might predispose to bowel perforation
- Infections:
- Active current or history of recurrent bacterial, viral fungal, mycobacterial,
or other infection
- Prior episode of major infection
- Active TB requiring treatment within the previous 3 years
- Untreated latent TB infection (LTBI)
- Primary or secondary immunodeficiency
- Malignancy (except for basal and squamous cell carcinoma of the skin or carcinoma in
situ of the cervix uteri that has been excised and cured)
- Inadequate hematologic, renal or liver function
- Positive for hepatitis B or hepatitis C infection
Reference Study ID Number: WA28119 www.roche.com/about_roche/roche_worldwide.htm, Phone: 888-662-6728 (U.S. Only), Email: global.rochegenentechtrials@roche.com
Graz 8036, Austria; Terminated
Bruxelles 1070, Belgium; Active, not recruiting
Leuven 3000, Belgium; Active, not recruiting
Liège 4000, Belgium; Terminated
Hillerod 3400, Denmark; Terminated
Odense C 5000, Denmark; Terminated
Bobigny 93009, France; Active, not recruiting
Bondy 93143, France; Terminated
Brest 29609, France; Active, not recruiting
Lille 59037, France; Active, not recruiting
Marseille 13000, France; Active, not recruiting
Mulhouse 68070, France; Active, not recruiting
Paris 75571, France; Terminated
Paris 75679, France; Active, not recruiting
Bad Abbach 93077, Germany; Active, not recruiting
Bad Bramstedt 24576, Germany; Active, not recruiting
Baden-Baden 76530, Germany; Terminated
Berlin 10117, Germany; Active, not recruiting
Berlin 14059, Germany; Active, not recruiting
Dresden 01307, Germany; Active, not recruiting
Erlangen 91054, Germany; Active, not recruiting
Frankfurt 60596, Germany; Terminated
Freiburg 79106, Germany; Active, not recruiting
Hannover 30625, Germany; Active, not recruiting
Herne 44652, Germany; Completed
Jena 07747, Germany; Active, not recruiting
Kiel 24105, Germany; Active, not recruiting
Mainz 55131, Germany; Active, not recruiting
Muenchen 80336, Germany; Active, not recruiting
Plochingen 73207, Germany; Active, not recruiting
Stuttgart 70376, Germany; Terminated
Tübingen 72076, Germany; Active, not recruiting
Amsterdam 1081 HV, Netherlands; Active, not recruiting
Arnhem 6815 AD, Netherlands; Active, not recruiting
Groningen 9700 RB, Netherlands; Active, not recruiting
Hengelo 7555 DL, Netherlands; Active, not recruiting
Nijmegen 6525 GA, Netherlands; Active, not recruiting
Førde 6800, Norway; Terminated
Kristiansand 4604, Norway; Active, not recruiting
Oslo 0027, Norway; Active, not recruiting
Trondheim 7006, Norway; Recruiting
Ålesund N-6026, Norway; Active, not recruiting
Bydgoszcz 85-168, Poland; Active, not recruiting
Szczecin 71-252, Poland; Active, not recruiting
Lisboa 1050-34, Portugal; Terminated
Porto 4099-001, Portugal; Active, not recruiting
Barcelona 08907, Spain; Active, not recruiting
Barcelona 8036, Spain; Active, not recruiting
Goteborg 413 45, Sweden; Active, not recruiting
Lund 221 85, Sweden; Active, not recruiting
Malmo 205 02, Sweden; Active, not recruiting
Stockholm 171 76, Sweden; Active, not recruiting
Uppsala 751 85, Sweden; Active, not recruiting
Aberdeen AB25 2ZN, United Kingdom; Active, not recruiting
Barnsley S75 2EP, United Kingdom; Active, not recruiting
Birmingham B15 2TH, United Kingdom; Active, not recruiting
Colchester, Essex CO4 5JL, United Kingdom; Recruiting
Edinburgh EH16 4TJ, United Kingdom; Active, not recruiting
Ipswich IP4 5PD, United Kingdom; Terminated
Kirkcaldy KY1 2ND, United Kingdom; Terminated
Leeds LS7 4SA, United Kingdom; Active, not recruiting
London EC1V 2PD, United Kingdom; Active, not recruiting
Newcastle Upon Tyne NE7 7DN, United Kingdom; Active, not recruiting
Romford RM7 0AG, United Kingdom; Active, not recruiting
Stoke-on-trent ST6 7AG, United Kingdom; Completed
Truro TR1 3LJ, United Kingdom; Active, not recruiting
Westcliffe-on-sea SS0 0RY, United Kingdom; Active, not recruiting
Paradise Valley, Arizona 85253, United States; Active, not recruiting
Los Angeles, California 90025, United States; Active, not recruiting
Los Angeles, California 90048, United States; Active, not recruiting
Reggio Emilia, Emilia-Romagna 42100, Italy; Active, not recruiting
Boca Raton, Florida 33486, United States; Active, not recruiting
Sarasota, Florida 34239, United States; Active, not recruiting
Tampa, Florida 33612-4799, United States; Recruiting
Udine, Friuli-Venezia Giulia 33100, Italy; Active, not recruiting
Gainesville, Georgia 30501, United States; Terminated
Chicago, Illinois 60612, United States; Recruiting
Wichita, Kansas 67207, United States; Terminated
Paducah, Kentucky 42003, United States; Active, not recruiting
A Coruna, La Coruña 15006, Spain; Active, not recruiting
Santiago de Compostela, La Coruña 15706, Spain; Terminated
Genova, Liguria 16132, Italy; Active, not recruiting
Milano, Lombardia 20132, Italy; Active, not recruiting
Pavia, Lombardia 27100, Italy; Terminated
Portland, Maine 04102, United States; Active, not recruiting
Baltimore, Maryland 21224, United States; Not yet recruiting
Boston, Massachusetts 02114, United States; Active, not recruiting
St. Claire Shores, Michigan 48081, United States; Active, not recruiting
Minneapolis, Minnesota 55455, United States; Terminated
Rochester, Minnesota 55905, United States; Active, not recruiting
Lake Success, New York 11042, United States; Terminated
New York, New York 10016, United States; Terminated
New York, New York 10021, United States; Active, not recruiting
Asheville, North Carolina 28803, United States; Active, not recruiting
Hamilton, Ontario L8N 2B6, Canada; Not yet recruiting
Toronto, Ontario M5G 1X5, Canada; Terminated
Philadelphia, Pennsylvania 19104, United States; Active, not recruiting
Trois-rivieres, Quebec G8Z 1Y2, Canada; Active, not recruiting
La Laguna, Tenerife 38320, Spain; Active, not recruiting
Austin, Texas 78758, United States; Recruiting
Houston, Texas 77004, United States; Recruiting
Firenze, Toscana 50141, Italy; Terminated
Pisa, Toscana 56126, Italy; Active, not recruiting
Prato, Toscana 59100, Italy; Active, not recruiting
Salt Lake City, Utah 84132, United States; Active, not recruiting
Padova, Veneto 35128, Italy; Active, not recruiting
Verona, Veneto 37126, Italy; Active, not recruiting
Bilbao, Vizcaya 48013, Spain; Active, not recruiting
Vancouver, Washington 98604, United States; Active, not recruiting
Wausau, Wisconsin 54401, United States; Active, not recruiting