An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
NCT ID: NCT01791153
Last Updated: 2020-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
251 participants
INTERVENTIONAL
2013-07-22
2018-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1: Tocilizumab qw + 26 weeks prednisone taper
Participants will receive tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants will receive prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Tocilizumab
Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.
Prednisone
Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
Prednisone Placebo
Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
Part 1: Tocilizumab q2w + 26 weeks prednisone taper
Participants will receive tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants will receive prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Tocilizumab
Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.
Prednisone
Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
Tocilizumab Placebo
Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
Prednisone Placebo
Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
Part 1: Placebo + 26 weeks prednisone taper
Participants will receive tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants will receive prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Prednisone
Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
Tocilizumab Placebo
Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
Prednisone Placebo
Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
Part 1: Placebo + 52 weeks prednisone taper
Participants will receive tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to a protocol-defined schedule. Participants will receive prednisone tapering oral daily doses for 52 weeks.
Prednisone
Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
Tocilizumab Placebo
Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
Prednisone Placebo
Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
Part 2: Open-Label Tocilizumab qw
Participants without sustained remission at Week 52 will receive open-label tocilizumab at a dose of 162 mg as SC injection qw and/or corticosteroids and/or methotrexate at the discretion of the investigator for a maximum of 104 weeks.
Tocilizumab
Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.
Corticosteroids
Participants without sustained remission at Week 52 will receive corticosteroids at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
Methotrexate
Participants without sustained remission at Week 52 will receive methotrexate at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
Interventions
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Tocilizumab
Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.
Prednisone
Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
Tocilizumab Placebo
Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
Prednisone Placebo
Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
Corticosteroids
Participants without sustained remission at Week 52 will receive corticosteroids at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
Methotrexate
Participants without sustained remission at Week 52 will receive methotrexate at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than \[\>\] 6 weeks before baseline and previous treatment with \>/= 40 milligrams per day prednisone \[or equivalent\] for at least 2 consecutive weeks at any time) GCA
* Active disease (presence of clinical signs and symptoms \[cranial or PMR\] and ESR \>/=30 mm/hour or CRP \>/=1 mg/dL) within 6 weeks of baseline visit
Exclusion Criteria
* Transplanted organs (except corneas with transplant performed \>3 months prior to screening)
* Major ischemic event, unrelated to GCA, 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; cell-depleting therapies including investigational agent; intravenous (IV) gamma globulin or plasmapheresis within 6 months of baseline; alkylating agents or with total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2 weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib; cyclophosphamide within 6 months of baseline; \>100 milligrams of daily IV methylprednisolone within 6 weeks of baseline
* Participants requiring systemic glucocorticoids for conditions other than GCA, which, in the opinion of the investigator, would interfere with adherence to the fixed glucocorticoid taper regimen and/or to assessment of efficacy in response to the test article
* History of severe allergic reactions to monoclonal antibodies or to prednisone
* Evidence of serious uncontrolled concomitant disease (for example, cardiovascular, respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or gastrointestinal \[GI\] disease)
* Current liver disease, as determined by the investigator
* History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation
* Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other infection
* Primary or secondary immunodeficiency
* Evidence of malignancies diagnosed within previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
* Inadequate hematologic, renal or liver function
* Positive for hepatitis B or hepatitis C infection
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Univ of Calif., Los Angeles; Rheumatology
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Rheumatology Assoc. of S. Florida - Clinical Research Center
Boca Raton, Florida, United States
Sarasota Arthritis Res Center
Sarasota, Florida, United States
Four Rivers Clinical Research Inc.
Paducah, Kentucky, United States
Rheumatology Associates
Portland, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Shores Rheumatology
Saint Clair Shores, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hospital For Special Surgery; Dept of Medicine - Rheumatology
New York, New York, United States
Asheville Arthritis & Osteoporosis Center, PA
Asheville, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Utah; Division of Rheumatology
Salt Lake City, Utah, United States
Marshfield Clinic Wausau Ctr
Wausau, Wisconsin, United States
Hospital Erasme
Brussels, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Clin. de Rhumatologie
Trois-Rivières, Quebec, Canada
Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731
Hillerød, , Denmark
Hopital Avicenne; Medecine Interne H5
Bobigny, , France
Hopital La Cavale Blanche; Rhumatologie
Brest, , France
Hopital Claude Huriez; Internal Medicine
Lille, , France
Hôpital de la Conception
Marseille, , France
Hopital Emile Muller; Medecine Interne
Mulhouse, , France
Hopital Cochin; Medecine Interne
Paris, , France
Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie
Bad Abbach, , Germany
Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie
Bad Bramstedt, , Germany
Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
Berlin, , Germany
Schlosspark Klinik; Abt. Rheumatologie
Berlin, , Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
Dresden, , Germany
Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie
Erlangen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
Hanover, , Germany
Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
Herne, , Germany
Universitätsklinikum Jena; Klinik für Innere Medizin III
Jena, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz, , Germany
Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
München, , Germany
Kreiskliniken Esslingen gGmbH Klinik Plochingen Medizinische Klinik
Plochingen, , Germany
Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
Tübingen, , Germany
Arcispedale Santa Maria Nuova; Reumatologia
Reggio Emilia, Emilia-Romagna, Italy
Policlinico Univ. Uni Degli Sudi Di Udine; Clinica Di Reumatologia
Udine, Friuli Venezia Giulia, Italy
Università Degli Studi Di Genova - Dimi; Reumatologia
Genoa, Liguria, Italy
Irccs San Raffele; Div Med Gen Immunologia Clinica
Milan, Lombardy, Italy
A.O. Universitaria Pisana; Psichiatria
Pisa, Tuscany, Italy
Azienda Ospedaliera di Padova; Cattedra e Divisione di Reumatologia
Padua, Veneto, Italy
Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
Verona, Veneto, Italy
VU Medisch Centrum; Reumatologie 4-A-A2
Amsterdam, , Netherlands
Ziekenhuis Rijnstate
Arnhem, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Ziekenhuisgroep Twente, Hengelo
Hengelo, , Netherlands
Akademisch Ziekenhuis St. Radboud; Rheumatology
Nijmegen, , Netherlands
Ålesund sjukehus
Ålesund, , Norway
Sørlandet Sykehus Kristiansand
Kristiansand, , Norway
Rikshospitalet; Revmatologisk Avd Seksjon Barnerevmatologi
Oslo, , Norway
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
Bydgoszcz, , Poland
Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
Szczecin, , Poland
Hospital Geral de Santo Antonio; Servico de Imunologia Clinica
Porto, , Portugal
Hospital Univ A Coruna; Rheumatology
A Coruña, LA Coruña, Spain
Hospital Universitario de Canarias;servicio de Reumatologia
San Cristóbal de La Laguna, Tenerife, Spain
Hospital de Basurto; Servicio de Reumatologia
Bilbao, Vizcaya, Spain
Hospital Universitari de Bellvitge; Servicio de Reumatologia
Barcelona, , Spain
University of Barcelona; Dept. of Internal Medicine,
Barcelona, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Skånes Universitetssjukhus
Lund, , Sweden
Skånes Universitetssjukhus Malmö; Reumatologkliniken
Malmo, , Sweden
Karolinska Sjukhuset; Reumatologkliniken D2-1
Stockholm, , Sweden
Akademiska Sjukhuset; Lungmedicinska Kliniken
Uppsala, , Sweden
Aberdeen Royal Infirmary; Medical Oncology Dept
Aberdeen, , United Kingdom
Barnsley General Hospital; Rheumatology
Barnsley, , United Kingdom
Old Queen Elizabeth Hospital; Pharmacy Building;Clinical Research offices
Birmingham, , United Kingdom
Colchester General Hospital; Aseptic Dept, Pharmacy Support Unit
Colchester, Essex, , United Kingdom
University of Edinburgh; The Queens Medical Research Institute
Edinburgh, , United Kingdom
CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease
Leeds, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Freeman Hospital; Dept of Rheumatology
Newcastle upon Tyne, , United Kingdom
Queen's Hospital
Romford, , United Kingdom
Haywood Hospital; Staffordshire Rheumatology Centre
Stoke-on-Trent, , United Kingdom
Royal Cornwall Hospital; Rhuematololgy Dept
Truro, , United Kingdom
Southend Hospital; Rheumatology Department
Westcliffe-on-sea, , United Kingdom
Countries
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References
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Stone JH, Han J, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Spiera R, Unizony SH, Bao M; GiACTA investigators. Long-term effect of tocilizumab in patients with giant cell arteritis: open-label extension phase of the Giant Cell Arteritis Actemra (GiACTA) trial. Lancet Rheumatol. 2021 May;3(5):e328-e336. doi: 10.1016/S2665-9913(21)00038-2. Epub 2021 Mar 19.
Stone JH, Spotswood H, Unizony SH, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Spiera R, Bao M. New-onset versus relapsing giant cell arteritis treated with tocilizumab: 3-year results from a randomized controlled trial and extension. Rheumatology (Oxford). 2022 Jul 6;61(7):2915-2922. doi: 10.1093/rheumatology/keab780.
Unizony SH, Bao M, Han J, Luder Y, Pavlov A, Stone JH. Treatment failure in giant cell arteritis. Ann Rheum Dis. 2021 Nov;80(11):1467-1474. doi: 10.1136/annrheumdis-2021-220347. Epub 2021 May 28.
Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schulze-Koops H, Schett G, Spiera R, Unizony SH, Collinson N. Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab. Arthritis Rheumatol. 2019 Aug;71(8):1329-1338. doi: 10.1002/art.40876. Epub 2019 Jul 3.
Strand V, Dimonaco S, Tuckwell K, Klearman M, Collinson N, Stone JH. Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial. Arthritis Res Ther. 2019 Feb 20;21(1):64. doi: 10.1186/s13075-019-1837-7.
Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.
Other Identifiers
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2011-006022-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA28119
Identifier Type: -
Identifier Source: org_study_id
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