An Efficacy and Safety Study of Tocilizumab (RoActemra/Ac... | NCT01791153 | Trialant
NCT01791153
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Feb 6, 2020Actual
Enrollment
251Actual
Phase
Phase 3
Conditions
Giant Cell Arteritis
Interventions
Tocilizumab
Prednisone
Tocilizumab Placebo
Prednisone Placebo
Corticosteroids
Methotrexate
Countries
United States
Belgium
Canada
Denmark
France
Germany
Italy
Netherlands
Norway
Poland
Portugal
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01791153
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
WA28119
Secondary IDs
ID
Type
Description
Link
2011-006022-25
EudraCT Number
Brief Title
An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
Official Title
A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Feb 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 22, 2013Actual
Primary Completion Date
Apr 11, 2016Actual
Completion Date
Jun 4, 2018Actual
First Submitted Date
Feb 12, 2013
First Submission Date that Met QC Criteria
Feb 12, 2013
First Posted Date
Feb 13, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 10, 2017
Results First Submitted that Met QC Criteria
Apr 10, 2017
Results First Posted Date
May 18, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 4, 2020
Last Update Posted Date
Feb 6, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
Not provided
Conditions Module
Conditions
Giant Cell Arteritis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
251Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Tocilizumab qw + 26 weeks prednisone taper
Experimental
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
Drug: Prednisone
Drug: Prednisone Placebo
Part 1: Tocilizumab q2w + 26 weeks prednisone taper
Experimental
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
Drug: Prednisone
Drug: Tocilizumab Placebo
Drug: Prednisone Placebo
Part 1: Placebo + 26 weeks prednisone taper
Placebo Comparator
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
Drug: Tocilizumab Placebo
Drug: Prednisone Placebo
Part 1: Placebo + 52 weeks prednisone taper
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tocilizumab
Drug
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.
Outcomes Module
Primary Outcomes
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 Outcomes
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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)
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.
Of the 363 participants screened, a total of 251 participants were randomized into the study. One participant who was randomized to the "Tocilizumab q2w + 26 weeks prednisone taper" group withdrew on the same day of randomization and did not receive any study treatment. This participant was not included in any of the study analyses.
Recruitment Details
The study consists 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).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection every week (qw) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Periods
Title
Milestones
Reasons Not Completed
Part 1: Blinded Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo Comparator
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
Drug: Tocilizumab Placebo
Drug: Prednisone Placebo
Part 2: Open-Label Tocilizumab qw
Experimental
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
Drug: Corticosteroids
Drug: Methotrexate
Part 1: Tocilizumab q2w + 26 weeks prednisone taper
Part 1: Tocilizumab qw + 26 weeks prednisone taper
Part 2: Open-Label Tocilizumab qw
RoActemra, Actemra, RO4877533
Prednisone
Drug
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.
Part 1: Placebo + 26 weeks prednisone taper
Part 1: Placebo + 52 weeks prednisone taper
Part 1: Tocilizumab q2w + 26 weeks prednisone taper
Part 1: Tocilizumab qw + 26 weeks prednisone taper
Tocilizumab Placebo
Drug
Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
Part 1: Placebo + 26 weeks prednisone taper
Part 1: Placebo + 52 weeks prednisone taper
Part 1: Tocilizumab q2w + 26 weeks prednisone taper
Prednisone Placebo
Drug
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
Part 1: Placebo + 52 weeks prednisone taper
Part 1: Tocilizumab q2w + 26 weeks prednisone taper
Part 1: Tocilizumab qw + 26 weeks prednisone taper
Corticosteroids
Drug
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.
Part 2: Open-Label Tocilizumab qw
Methotrexate
Drug
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.
Part 2: Open-Label Tocilizumab qw
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
Los Angeles
California
90048
United States
Rheumatology Assoc. of S. Florida - Clinical Research Center
Boca Raton
Florida
33486
United States
Sarasota Arthritis Res Center
Sarasota
Florida
34239
United States
Four Rivers Clinical Research Inc.
Paducah
Kentucky
42003
United States
Rheumatology Associates
Portland
Maine
04102
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Shores Rheumatology
Saint Clair Shores
Michigan
48081
United States
Mayo Clinic Rochester
Rochester
Minnesota
55902
United States
Hospital For Special Surgery; Dept of Medicine - Rheumatology
New York
New York
10021
United States
Asheville Arthritis & Osteoporosis Center, PA
Asheville
North Carolina
28803
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
University of Utah; Division of Rheumatology
Salt Lake City
Utah
84132
United States
Marshfield Clinic Wausau Ctr
Wausau
Wisconsin
54401
United States
Hospital Erasme
Brussels
1070
Belgium
UZ Leuven Gasthuisberg
Leuven
3000
Belgium
Clin. de Rhumatologie
Trois-Rivières
Quebec
G8Z 1Y2
Canada
Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731
Hillerød
3400
Denmark
Hopital Avicenne; Medecine Interne H5
Bobigny
93009
France
Hopital La Cavale Blanche; Rhumatologie
Brest
29609
France
Hopital Claude Huriez; Internal Medicine
Lille
59037
France
Hôpital de la Conception
Marseille
13000
France
Hopital Emile Muller; Medecine Interne
Mulhouse
68070
France
Hopital Cochin; Medecine Interne
Paris
75679
France
Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie
Bad Abbach
93077
Germany
Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie
Bad Bramstedt
24576
Germany
Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
Berlin
10117
Germany
Schlosspark Klinik; Abt. Rheumatologie
Berlin
14059
Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
Dresden
01307
Germany
Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie
Erlangen
91054
Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau
79106
Germany
Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie
Hanover
30625
Germany
Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie
Herne
44652
Germany
Universitätsklinikum Jena; Klinik für Innere Medizin III
Jena
07747
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
Mainz
55131
Germany
Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV
Old Queen Elizabeth Hospital; Pharmacy Building;Clinical Research offices
Birmingham
B15 2TH
United Kingdom
Colchester General Hospital; Aseptic Dept, Pharmacy Support Unit
Colchester, Essex
CO4 5JL
United Kingdom
University of Edinburgh; The Queens Medical Research Institute
Edinburgh
EH16 4TJ
United Kingdom
CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease
Leeds
LS7 4SA
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom
Freeman Hospital; Dept of Rheumatology
Newcastle upon Tyne
NE7 7DN
United Kingdom
Queen's Hospital
Romford
RM7 0AG
United Kingdom
Haywood Hospital; Staffordshire Rheumatology Centre
Stoke-on-Trent
ST6 7AG
United Kingdom
Royal Cornwall Hospital; Rhuematololgy Dept
Truro
TR1 3LJ
United Kingdom
Southend Hospital; Rheumatology Department
Westcliffe-on-sea
SS0 0RY
United Kingdom
Derived
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.
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.
FG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection every 2 weeks (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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
FG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
FG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
FG004
Part 2: No Tocilizumab (Placebo in Part 1)
Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received placebo during Part 1 (Weeks 1 to 52).
FG005
Part 2: No Tocilizumab (Tocilizumab in Part 1)
Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received tocilizumab during Part 1 (Weeks 1 to 52).
FG006
Part 2: Tocilizumab (Placebo in Part 1)
Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received placebo during Part 1 (Weeks 1 to 52).
FG007
Part 2: Tocilizumab (Tocilizumab in Part 1)
Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received tocilizumab during Part 1 (Weeks 1 to 52).
FG000100 subjects
FG00149 subjects
FG00250 subjects
FG00351 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00085 subjectsCompleted Study to Week 52
FG00141 subjectsCompleted Study to Week 52
FG00244 subjectsCompleted Study to Week 52
FG00346 subjectsCompleted Study to Week 52
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00015 subjects
FG0018 subjects
FG0026 subjects
FG0035 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lack of Efficacy
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG004
Non-Compliance
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Part 2: Open-label Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00440 subjects
FG00558 subjects
FG00650 subjects
FG00767 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety Population included all participants who received at least one administration of study drug and provided at least one post-dose safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
BG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
BG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
BG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000100
BG00149
BG00250
BG00351
BG004250
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00069.5± 8.50
BG00169.4± 8.29
BG00269.3± 8.14
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00078
BG00134
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Intent-to-treat (ITT) population included all participants randomized into the study who received at least one administration of study drug.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Units
Counts
Participants
OG000100
OG00149
OG00250
Title
Denominators
Categories
Title
Measurements
OG00056.0
OG00153.1
OG00214.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (less than or equal to [</=] 30 mg/day, greater than [>] 30 mg/day).
Cochran-Mantel-Haenszel
<0.0001
Difference in Response Rates
42.00
2-Sided
99.5
18.00
66.00
Superiority or Other (legacy)
OG001
Secondary
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.
ITT population
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
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.
ITT population
Posted
Median
99% Confidence Interval
days
Up to 52 weeks
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Secondary
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.
ITT Population
Posted
Median
95% Confidence Interval
milligrams (mg)
Up to 52 weeks
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
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.
ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Secondary
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.
ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
Posted
Mean
Standard Deviation
mm
Baseline, Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
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).
Pharmacokinetics (PK)-evaluable population included all participants who received at least one tocilizumab injection and had at least one PK sample with detectable results taken at any time during the study.
Posted
Mean
Standard Deviation
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])
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
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).
PK-evaluable population
Posted
Mean
Standard Deviation
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])
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
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.
PK-evaluable population
Posted
Mean
Standard Deviation
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])
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Units
Secondary
Minimum Observed Serum Concentration (Ctrough) of Tocilizumab
Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL.
PK-evaluable population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
Posted
Mean
Standard Deviation
mcg/mL
Predose (Hour 0) at Baseline and Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
Serum Interleukin-6 (IL-6) Level
Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
Posted
Mean
Standard Deviation
picograms per milliliter (pg/mL)
Baseline and Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
Serum Soluble IL-6 Receptor (sIL-6R) Level
Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Baseline and Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Secondary
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.
Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
Posted
Median
Inter-Quartile Range
mm/hr
Baseline and Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Secondary
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.
Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
Posted
Median
Inter-Quartile Range
milligrams per liter (mg/L)
Baseline and Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Secondary
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.
Safety population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline up to Week 52
ID
Title
Description
OG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
Time Frame
Up to 156 weeks
Description
Safety population
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper
Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
15
100
87
100
EG001
Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
7
49
44
49
EG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
11
50
47
50
EG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
13
51
44
51
EG004
Part 2: No Tocilizumab (Placebo in Part 1)
Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received placebo during Part 1 (Weeks 1 to 52).
7
40
33
40
EG005
Part 2: No Tocilizumab (Tocilizumab in Part 1)
Participants did not receive tocilizumab in Part 2 from Week 52 up to Week 156. These participants received tocilizumab during Part 1 (Weeks 1 to 52).
11
58
50
58
EG006
Part 2: Tocilizumab (Placebo in Part 1)
Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received placebo during Part 1 (Weeks 1 to 52).
18
50
44
50
EG007
Part 2: Tocilizumab (Tocilizumab in Part 1)
Participants received open-label tocilizumab as determined by the investigator during Part 2 of the study (from Week 52 up to Week 156). These participants received tocilizumab during Part 1 (Weeks 1 to 52).
23
67
61
67
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Glaucoma
Eye disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG0030 affected51 at risk
EG0041 affected40 at risk
EG0050 affected58 at risk
EG0060 affected50 at risk
EG0070 affected67 at risk
Gastritis erosive
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Erysipelas
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Syncope
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Hypertension
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Temporal arteritis
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected49 at risk
EG0021 affected50 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cataract
Eye disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Genital herpes zoster
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Tachyarrhythmia
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Headache
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Stress
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Cholangitis infective
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Thrombotic stroke
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Dry gangrene
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0020 affected50 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
White blood cell disorder
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Visual acuity reduced transiently
Eye disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Incarcerated inguinal hernia
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Chest pain
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Impaired healing
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Device related infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Troponin increased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Chondropathy
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Squamous cell carcinoma of the vulva
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Presyncope
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Cancer surgery
Surgical and medical procedures
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Haematoma
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Aortic aneurysm rupture
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0012 affected49 at risk
EG0024 affected50 at risk
EG0032 affected51 at risk
EG0040 affected40 at risk
EG0050 affected58 at risk
EG0060 affected50 at risk
EG0070 affected67 at risk
Vertigo
Ear and labyrinth disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0011 affected49 at risk
EG0023 affected50 at risk
EG003
Cataract
Eye disorders
MedDRA v19.0
Non-systematic Assessment
EG0005 affected100 at risk
EG0011 affected49 at risk
EG0023 affected50 at risk
EG003
Dry eye
Eye disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0013 affected49 at risk
EG0021 affected50 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0013 affected49 at risk
EG0023 affected50 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0011 affected49 at risk
EG0023 affected50 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG00012 affected100 at risk
EG0013 affected49 at risk
EG0028 affected50 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0024 affected50 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0008 affected100 at risk
EG0012 affected49 at risk
EG0025 affected50 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0012 affected49 at risk
EG0022 affected50 at risk
EG003
Asthenia
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0005 affected100 at risk
EG0013 affected49 at risk
EG0025 affected50 at risk
EG003
Fatigue
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0008 affected100 at risk
EG0015 affected49 at risk
EG0028 affected50 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0012 affected49 at risk
EG0021 affected50 at risk
EG003
Oedema peripheral
General disorders
MedDRA v19.0
Non-systematic Assessment
EG00016 affected100 at risk
EG00112 affected49 at risk
EG0028 affected50 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0008 affected100 at risk
EG0014 affected49 at risk
EG0025 affected50 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0004 affected100 at risk
EG0011 affected49 at risk
EG0024 affected50 at risk
EG003
Cystitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0007 affected100 at risk
EG0010 affected49 at risk
EG0022 affected50 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0014 affected49 at risk
EG0024 affected50 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG00029 affected100 at risk
EG00112 affected49 at risk
EG0029 affected50 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0004 affected100 at risk
EG0015 affected49 at risk
EG0023 affected50 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0004 affected100 at risk
EG0010 affected49 at risk
EG0021 affected50 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0006 affected100 at risk
EG0014 affected49 at risk
EG0022 affected50 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0014 affected49 at risk
EG0021 affected50 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG00010 affected100 at risk
EG0016 affected49 at risk
EG0025 affected50 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG00010 affected100 at risk
EG0014 affected49 at risk
EG0022 affected50 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0007 affected100 at risk
EG0012 affected49 at risk
EG0022 affected50 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0005 affected100 at risk
EG0012 affected49 at risk
EG0022 affected50 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0013 affected49 at risk
EG0020 affected50 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG00013 affected100 at risk
EG0018 affected49 at risk
EG00210 affected50 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG00014 affected100 at risk
EG0017 affected49 at risk
EG0027 affected50 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0014 affected49 at risk
EG0022 affected50 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0004 affected100 at risk
EG0016 affected49 at risk
EG0026 affected50 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG00012 affected100 at risk
EG0016 affected49 at risk
EG0025 affected50 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0009 affected100 at risk
EG0014 affected49 at risk
EG0024 affected50 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0006 affected100 at risk
EG0011 affected49 at risk
EG0022 affected50 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0007 affected100 at risk
EG0012 affected49 at risk
EG0023 affected50 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0008 affected100 at risk
EG0015 affected49 at risk
EG0025 affected50 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0006 affected100 at risk
EG00110 affected49 at risk
EG0026 affected50 at risk
EG003
Headache
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG00027 affected100 at risk
EG00110 affected49 at risk
EG00216 affected50 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0004 affected100 at risk
EG0012 affected49 at risk
EG0024 affected50 at risk
EG003
Tremor
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0023 affected50 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0011 affected49 at risk
EG0026 affected50 at risk
EG003
Depression
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0012 affected49 at risk
EG0023 affected50 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0004 affected100 at risk
EG0011 affected49 at risk
EG0024 affected50 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0013 affected49 at risk
EG0021 affected50 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0006 affected100 at risk
EG0013 affected49 at risk
EG0027 affected50 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0013 affected49 at risk
EG0021 affected50 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0010 affected49 at risk
EG0023 affected50 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0003 affected100 at risk
EG0011 affected49 at risk
EG0024 affected50 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0007 affected100 at risk
EG0014 affected49 at risk
EG0024 affected50 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0005 affected100 at risk
EG0017 affected49 at risk
EG0023 affected50 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0013 affected49 at risk
EG0020 affected50 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0012 affected49 at risk
EG0021 affected50 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 affected100 at risk
EG0013 affected49 at risk
EG0021 affected50 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 affected100 at risk
EG0014 affected49 at risk
EG0021 affected50 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0007 affected100 at risk
EG0015 affected49 at risk
EG0024 affected50 at risk
EG003
Haematoma
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0005 affected100 at risk
EG0013 affected49 at risk
EG0023 affected50 at risk
EG003
Hypertension
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG00012 affected100 at risk
EG0016 affected49 at risk
EG0024 affected50 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Discomfort
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Gait disturbance
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Influenza
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Complement factor C3 decreased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Complement factor C4 decreased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Syncope
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 affected100 at risk
EG0010 affected49 at risk
EG0020 affected50 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Hoffmann-La Roche
800-821-8590
genentech@druginfo.com
ID
Term
D013700
Giant Cell Arteritis
Ancestor Terms
ID
Term
D020293
Vasculitis, Central Nervous System
D020274
Autoimmune Diseases of the Nervous System
D009422
Nervous System Diseases
D002561
Cerebrovascular Disorders
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D001167
Arteritis
D014657
Vasculitis
D017445
Skin Diseases, Vascular
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C502936
tocilizumab
D011241
Prednisone
D000305
Adrenal Cortex Hormones
D008727
Methotrexate
Ancestor Terms
ID
Term
D011244
Pregnadienediols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
38 subjects
FG00554 subjects
FG00644 subjects
FG00761 subjects
2 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0063 subjects
FG0072 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
67.8
± 7.70
BG00469.1± 8.21
38
BG00337
BG004187
Male
BG00022
BG00115
BG00212
BG00314
BG00463
OG002
The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Cochran-Mantel-Haenszel
< 0.0001
Difference in Response Rates
39.06
2-Sided
99.5
12.46
65.66
Superiority or Other (legacy)
OG002
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00251
Title
Denominators
Categories
Title
Measurements
OG00056.0
OG00153.1
OG00217.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Cochran-Mantel-Haenszel
< 0.0001
Superiority or Other (legacy)
OG000
OG002
The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Difference in Response Rates
38.35
2-Sided
99.5
17.89
58.81
Non-Inferiority or Equivalence (legacy)
The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was >/= -22.5%.
OG001
OG002
The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Cochran-Mantel-Haenszel
0.0002
Superiority or Other (legacy)
OG001
OG002
The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Difference in Response Rates
35.41
2-Sided
99.5
10.41
60.41
Non-Inferiority or Equivalence (legacy)
The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was >/= -22.5%.
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00250
OG00351
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data could not be calculated due to low number of participants who had an event.
OG001NA(NA to NA)Data could not be calculated due to low number of participants who had an event.
OG002165.0(120.0 to 260.0)
OG003295.0(168.0 to NA)Data could not be calculated due to low number of participants who had an event.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Cox proportional hazards model
<0.0001
Hazard Ratio (HR)
0.23
2-Sided
99
0.11
0.46
Superiority or Other (legacy)
OG000
OG003
The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Cox proportional hazards model
0.0011
Hazard Ratio (HR)
0.39
2-Sided
99
0.18
0.82
Superiority or Other (legacy)
OG001
OG002
The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Cox proportional hazards model
0.0001
Hazard Ratio (HR)
0.28
2-Sided
99
0.12
0.66
Superiority or Other (legacy)
OG001
OG003
The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).
Cox proportional hazards model
0.0316
Hazard Ratio (HR)
0.48
2-Sided
99
0.20
1.16
Superiority or Other (legacy)
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00250
OG00351
Title
Denominators
Categories
Title
Measurements
OG0001862.00(1582.0 to 1942.0)
OG0011862.00(1568.0 to 2239.5)
OG0023296.00(2729.5 to 4023.5)
OG0033817.50(2817.5 to 4425.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30 mg/day, > 30 mg/day).
Van Elteren's test
<0.0001
Superiority or Other (legacy)
OG000
OG003
The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30 mg/day, > 30 mg/day).
Van Elteren's test
<0.0001
Superiority or Other (legacy)
OG001
OG002
The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30mg/day, >30mg/day).
Van Elteren's test
0.0003
Superiority or Other (legacy)
OG001
OG003
The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30 mg/day, > 30 mg/day).
Van Elteren's test
<0.0001
Superiority or Other (legacy)
Participants received 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 received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG00097
OG00149
OG00248
OG00349
Title
Denominators
Categories
PCS: Baseline (n=97,49,48,49)
Title
Measurements
OG00043.10± 9.43
OG00140.62± 8.00
OG00242.65± 10.87
OG00341.12± 9.97
PCS: Change at Week 52 (n=59,26,9,18)
Title
Measurements
OG0005.37± 7.38
OG0012.71± 8.86
OG0022.08± 12.11
OG003
MCS: Baseline (n=97,49,48,49)
Title
Measurements
OG00042.77± 12.43
OG00147.67± 12.59
OG00242.73± 12.13
OG003
MCS: Change at Week 52 (n=59,26,9,18)
Title
Measurements
OG0008.21± 10.35
OG0011.98± 7.17
OG0024.99± 7.54
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.8067
Difference in Least Square Means
0.61
2-Sided
99
-5.86
7.07
Superiority or Other (legacy)
OG000
OG003
MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0252
Difference in Least Square Means
4.44
2-Sided
99
-0.69
9.56
Superiority or Other (legacy)
OG001
OG002
MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.8374
Difference in Least Square Means
-0.56
2-Sided
99
-7.64
6.53
Superiority or Other (legacy)
OG001
OG003
MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.1468
Difference in Least Square Means
3.27
2-Sided
99
-2.59
9.14
Superiority or Other (legacy)
OG000
OG002
PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0570
Difference in Least Square Means
4.38
2-Sided
99
-1.58
10.34
Superiority or Other (legacy)
OG000
OG003
PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0024
Difference in Least Square Means
5.59
2-Sided
99
0.86
10.32
Superiority or Other (legacy)
OG001
OG002
PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.2218
Difference in Least Square Means
3.04
2-Sided
99
-3.43
9.51
Superiority or Other (legacy)
OG001
OG003
PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0412
Difference in Least Square Means
4.25
2-Sided
99
-1.14
9.64
Superiority or Other (legacy)
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00249
OG00351
Title
Denominators
Categories
Baseline (n=100,49,49,51)
Title
Measurements
OG00043.61± 25.66
OG00146.65± 25.60
OG00235.73± 28.15
OG00347.78± 27.80
Change at Week 52 (n=60,26,11,18)
Title
Measurements
OG000-19.68± 33.64
OG001-22.69± 22.41
OG002-8.45± 24.81
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0312
Difference in Least Square Means
-15.6
2-Sided
99
-34.3
3.1
Superiority or Other (legacy)
OG000
OG003
Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0476
Difference in Least Square Means
-11.8
2-Sided
99
-27.2
3.6
Superiority or Other (legacy)
OG001
OG002
Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0059
Difference in Least Square Means
-21.9
2-Sided
99
-42.4
-1.4
Superiority or Other (legacy)
OG001
OG003
Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.
Repeated measures model
0.0081
Difference in Least Square Means
-18.2
2-Sided
99
-35.8
-0.5
Superiority or Other (legacy)
Units
Counts
Participants
OG000100
OG00149
Title
Denominators
Categories
Title
Measurements
OG000499.2± 210.4
OG001227.2± 165.4
Units
Counts
Participants
OG000100
OG00149
Title
Denominators
Categories
Title
Measurements
OG00073± 30.4
OG00119.3± 12.8
Counts
Participants
OG000100
OG00149
Title
Denominators
Categories
Title
Measurements
OG00068.1± 29.5
OG00111.1± 10.3
Units
Counts
Participants
OG00099
OG00148
Title
Denominators
Categories
Baseline (n= 99, 48)
Title
Measurements
OG0000.07± 0.72
OG0010.00± 0.02
Week 52 (n= 72, 33)
Title
Measurements
OG00067.93± 34.40
OG00112.22± 10.02
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00250
OG00351
Title
Denominators
Categories
Baseline (n=91,44,50,47)
Title
Measurements
OG0008.79± 10.01
OG00116.29± 31.23
OG00212.73± 18.04
OG0038.31± 9.47
Week 52 (n=69,32,28,30)
Title
Measurements
OG00065.99± 84.92
OG00152.70± 33.10
OG00235.96± 149.65
OG003
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00250
OG00351
Title
Denominators
Categories
Baseline (n=99,48,50,50)
Title
Measurements
OG00051.34± 61.98
OG00150.82± 63.51
OG00242.07± 11.32
OG00340.37± 10.84
Week 52 (n=73,33,33,31)
Title
Measurements
OG000600.53± 217.52
OG001464.30± 153.64
OG00276.44± 149.20
OG003
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00250
OG00351
Title
Denominators
Categories
Baseline (n=99,49,50,51)
Title
Measurements
OG00019.00± 61.98(10.00 to 35.00)
OG00115.00± 63.51(10.00 to 30.00)
OG00223.00± 11.32(9.00 to 36.00)
OG00320.00± 10.84(8.00 to 38.00)
Week 52 (n=76,35,35,33)
Title
Measurements
OG0003.00(2.00 to 5.00)
OG0015.00(2.00 to 7.00)
OG00220.00(11.00 to 36.00)
OG003
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
Units
Counts
Participants
OG000100
OG00149
OG00250
OG00351
Title
Denominators
Categories
Baseline (n=100,49,50,51)
Title
Measurements
OG0003.67± 61.98(1.02 to 9.26)
OG0014.52± 63.51(1.55 to 9.75)
OG0023.64± 11.32(1.20 to 9.59)
OG0033.56± 10.84(1.17 to 7.24)
Week 52 (n=76,35,35,33)
Title
Measurements
OG0000.30(0.20 to 0.59)
OG0010.33(0.20 to 0.72)
OG0024.90(2.25 to 9.25)
OG003
OG002
Part 1: Placebo + 26 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
OG003
Part 1: Placebo + 52 Weeks Prednisone Taper
Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.