An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)

A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.

Study Overview

• Status: Completed
• Conditions: Giant Cell Arteritis
• Intervention / Treatment: Drug: Tocilizumab; Drug: Prednisone; Drug: Prednisone Placebo; Drug: Tocilizumab Placebo; Drug: Corticosteroids; Drug: Methotrexate

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Hospital Erasme
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Canada
  • Quebec
    • Trois-rivieres, Quebec, Canada, G8Z 1Y2
      • Clin. de Rhumatologie
• Denmark
  • Hillerod, Denmark, 3400
    • Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731
• France
  • Bobigny, France, 93009
    • Hopital Avicenne; Medecine Interne H5
  • Brest, France, 29609
    • Hopital La Cavale Blanche; Rhumatologie
  • Lille, France, 59037
    • Hopital Claude Huriez; Internal Medicine
  • Marseille, France, 13000
    • Hôpital de la Conception
  • Mulhouse, France, 68070
    • Hopital Emile Muller; Medecine Interne
  • Paris, France, 75679
    • Hopital Cochin; Medecine Interne
• Germany
  • Bad Abbach, Germany, 93077
    • Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie
  • Bad Bramstedt, Germany, 24576
    • Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie
  • Berlin, Germany, 10117
    • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
  • Berlin, Germany, 14059
    • Schlosspark Klinik; Abt. Rheumatologie
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Hannover, Germany, 30625
    • Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
  • Herne, Germany, 44652
    • Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
  • Jena, Germany, 07747
    • Universitätsklinikum Jena; Klinik für Innere Medizin III
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
  • München, Germany, 80336
    • Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
  • Plochingen, Germany, 73207
    • Kreiskliniken Esslingen gGmbH Klinik Plochingen Medizinische Klinik
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II
• Italy
  • Emilia-Romagna
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • Arcispedale Santa Maria Nuova; Reumatologia
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Policlinico Univ. Uni Degli Sudi Di Udine; Clinica Di Reumatologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Università Degli Studi Di Genova - Dimi; Reumatologia
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • Irccs San Raffele; Div Med Gen Immunologia Clinica
  • Toscana
    • Pisa, Toscana, Italy, 56126
      • A.O. Universitaria Pisana; Psichiatria
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedaliera di Padova; Cattedra e Divisione di Reumatologia
    • Verona, Veneto, Italy, 37126
      • Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum; Reumatologie 4-A-A2
  • Arnhem, Netherlands, 6815 AD
    • Ziekenhuis Rijnstate
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Hengelo, Netherlands, 7555 DL
    • Ziekenhuisgroep Twente, Hengelo
  • Nijmegen, Netherlands, 6525 GA
    • Akademisch Ziekenhuis St. Radboud; Rheumatology
• Norway
  • Kristiansand, Norway, 4604
    • Sørlandet Sykehus Kristiansand
  • Oslo, Norway, 0027
    • Rikshospitalet; Revmatologisk Avd Seksjon Barnerevmatologi
  • Ålesund, Norway, N-6026
    • Alesund sjukehus
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
  • Szczecin, Poland, 71-252
    • Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1
• Portugal
  • Porto, Portugal, 4099-001
    • Hospital Geral de Santo Antonio; Servico de Imunologia Clinica
• Spain
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge; Servicio de Reumatologia
  • Barcelona, Spain, 8036
    • University of Barcelona; Dept. of Internal Medicine,
  • LA Coruña
    • A Coruna, LA Coruña, Spain, 15006
      • Hospital Univ A Coruna; Rheumatology
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias;servicio de Reumatologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto; Servicio de Reumatologia
• Sweden
  • Goteborg, Sweden, 413 45
    • Sahlgrenska Universitetssjukhuset
  • Lund, Sweden, 221 85
    • Skanes Universitetssjukhus
  • Malmo, Sweden, 205 02
    • Skånes Universitetssjukhus Malmö; Reumatologkliniken
  • Stockholm, Sweden, 171 76
    • Karolinska Sjukhuset; Reumatologkliniken D2-1
  • Uppsala, Sweden, 751 85
    • Akademiska Sjukhuset; Lungmedicinska Kliniken
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary; Medical Oncology Dept
  • Barnsley, United Kingdom, S75 2EP
    • Barnsley General Hospital; Rheumatology
  • Birmingham, United Kingdom, B15 2TH
    • Old Queen Elizabeth Hospital; Pharmacy Building;Clinical Research offices
  • Colchester, Essex, United Kingdom, CO4 5JL
    • Colchester General Hospital; Aseptic Dept, Pharmacy Support Unit
  • Edinburgh, United Kingdom, EH16 4TJ
    • University of Edinburgh; The Queens Medical Research Institute
  • Leeds, United Kingdom, LS7 4SA
    • CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital; Dept of Rheumatology
  • Romford, United Kingdom, RM7 0AG
    • Queen's Hospital
  • Stoke-on-trent, United Kingdom, ST6 7AG
    • Haywood Hospital; Staffordshire Rheumatology Centre
  • Truro, United Kingdom, TR1 3LJ
    • Royal Cornwall Hospital; Rhuematololgy Dept
  • Westcliffe-on-sea, United Kingdom, SS0 0RY
    • Southend Hospital; Rheumatology Department
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90025
      • Univ of Calif., Los Angeles; Rheumatology
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Rheumatology Assoc. of S. Florida - Clinical Research Center
    • Sarasota, Florida, United States, 34239
      • Sarasota Arthritis Res Center
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research Inc.
  • Maine
    • Portland, Maine, United States, 04102
      • Rheumatology Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48081
      • Shores Rheumatology
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Rochester
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery; Dept of Medicine - Rheumatology
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Arthritis & Osteoporosis Center, PA
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah; Division of Rheumatology
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Marshfield Clinic Wausau Ctr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of GCA classified according to age >/=50 years; history of ESR >/=50 mm/hr or history of CRP >/=2.45 mg/dL; and at least one of the following: unequivocal cranial symptoms of GCA or symptoms of polymyalgia rheumatica [PMR]; and at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large-vessel vasculitis by angiography or cross-sectional imaging
• 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:

• Major surgery within 8 weeks prior to screening or planned within 12 months after randomization
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: 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.; Other Names: RoActemra, Actemra, RO4877533; Drug: 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.; Drug: 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.
EXPERIMENTAL: 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.	Drug: 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.; Other Names: RoActemra, Actemra, RO4877533; Drug: 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.; Drug: 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.; Drug: Tocilizumab Placebo; Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
PLACEBO_COMPARATOR: 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.	Drug: 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.; Drug: 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.; Drug: Tocilizumab Placebo; Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
PLACEBO_COMPARATOR: 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.	Drug: 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.; Drug: 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.; Drug: Tocilizumab Placebo; Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
EXPERIMENTAL: 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.	Drug: 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.; Other Names: RoActemra, Actemra, RO4877533; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)	Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than [<] 1 milligram per deciliter [mg/dL]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)	Remission was defined as the absence of flare and normalization of the CRP (<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.	Week 52
Time to First GCA Disease Flare	Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal.	Up to 52 weeks
Total Cumulative Prednisone Dose	The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented.	Up to 52 weeks
Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52	The SF-36 is a standardized questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Score (PCS) and Mental Component Score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A positive change from baseline indicates improvement. No imputation was used for missing data. Data was set to missing for participants who received escape therapy.	Baseline, Week 52
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52	Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement.	Baseline, Week 52
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab	AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram*day per milliliter (mcg*day/mL).	Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])
Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab	Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL).	Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])
Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab	Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL.	Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])
Minimum Observed Serum Concentration (Ctrough) of Tocilizumab	Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL.	Predose (Hour 0) at Baseline and Week 52
Serum Interleukin-6 (IL-6) Level		Baseline and Week 52
Serum Soluble IL-6 Receptor (sIL-6R) Level		Baseline and Week 52
Erythrocyte Sedimentation Rate (ESR)	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.	Baseline and Week 52
C-Reactive Protein (CRP) Level	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Baseline and Week 52
Percentage of Participants With Anti-Tocilizumab Antibodies	All samples were tested by screening assay, and those samples that were positive were further analyzed by a confirmation assay to confirm specificity. Percentage of participants who has a positive confirmation assay result any time after the initial drug administration with a negative confirmation assay result at baseline was reported.	Baseline up to Week 52

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2013
• Primary Completion (ACTUAL): April 11, 2016
• Study Completion (ACTUAL): June 4, 2018

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Prednisone; Methotrexate
• Other Study ID Numbers: WA28119; 2011-006022-25 (EUDRACT_NUMBER)