- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03202368
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
September 2, 2020 updated by: Hoffmann-La Roche
An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Patients With Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently Having Flare or Persisting Disease Activity.
This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who subsequently have flare or persisting disease activity.
A maximum of 11 participants from six centers in France that participated in the WA28119 study will be enrolled.
The entire study duration is anticipated to be approximately 160 weeks.
Study Overview
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brest, France, 29609
- Hopital La Cavale Blanche; Rhumatologie
-
Lille, France, 59037
- Hopital Claude Huriez; Internal Medicine
-
Mulhouse, France, 68070
- Hopital Emile Muller; Medecine Interne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants who completed the 156-week WA28119 core study in France
- Participants who experienced at any time during the WA28119 core study a clinical improvement based on the Investigator's judgment and may continue to benefit from SC tocilizumab in this study
- Participants whom the investigator wants to treat with SC tocilizumab due to persistent active GCA at the time of completion of the 156-week WA28119 core study and/or new flare occurring within 3 years after completion of the 156-week WA28119 core study
Exclusion Criteria:
- Participants who have prematurely withdrawn from the WA28119 core study for any reason
- Participants who had major surgery within 8 weeks prior to screening or planned major surgery within the next 12 months
- Major ischemic event, unrelated to GCA, within 12 weeks of inclusion
- Transplanted organs (except corneal transplant performed more than 3 months prior to inclusion)
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, or gastrointestinal (GI) disease
- Current liver disease, as determined by the investigator (positive hepatitis B surface antigen or hepatitis C antibody)
- History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a participant to perforations
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
- Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of inclusion or oral antibiotics within 2 weeks of inclusion
- Active TB requiring treatment within the previous 3 years
- Primary or secondary immunodeficiency (history of or currently active)
- Evidence of malignant disease or malignancies diagnosed since last WA28119 study visit (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
- Female participants of childbearing potential and female participants who are breastfeeding
- Male participants of reproductive potential who are not willing to use an effective method of contraception, such as condom, sterilization, or true abstinence throughout study and for a minimum of 6 months after study drug therapy
- History of alcohol, drug, or chemical abuse within 1 year prior to inclusion
- Body weight of more than (>) 150 kilograms
- Treatment with any investigational agent within 12 weeks (or five half-lives of the investigational drug, whichever is longer) of inclusion (except tocilizumab)
- Previous treatment with cell-depleting therapies including investigational agents, including but not limited to Campath (alemtuzumab), anti-cluster of differentiation (CD) 4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20
- Treatment with IV gamma globulin or plasmapheresis within 6 months of inclusion
- Previous treatment with alkylating agents such as chlorambucil or with total lymphoid irradiation
- Immunization with a live/attenuated vaccine within less than or equal to (≤) 4 weeks prior to inclusion
- Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or mycophenolate mofetil within 4 weeks of inclusion
- Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of inclusion
- Previous treatment with tofacitinib
- Treatment with cyclophosphamide within 6 months of inclusion
- Participants requiring systemic corticosteroids for other conditions other than GCA, which, in the opinion of the Investigator, would interfere with the assessments of the protocol
- Receipt of more than (>) 100 mg daily intravenous methylprednisolone within 6 weeks of inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tocilizumab: GCA Flare or Persistent Disease Activity
Participants who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119, will receive SC tocilizumab in this study.
|
162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects with Adverse Events
Time Frame: Baseline up to 160 weeks
|
Baseline up to 160 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Baseline up to 160 weeks
Time Frame: Baseline (Week 0), Weeks 48, 96, 156
|
Baseline (Week 0), Weeks 48, 96, 156
|
Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score
Time Frame: Baseline (Week 0), Weeks 48, 96, 156
|
Baseline (Week 0), Weeks 48, 96, 156
|
Change from Baseline in Erythrocyte Sedimentation Rate Values
Time Frame: Baseline (Week 0), Weeks 48, 96, 156
|
Baseline (Week 0), Weeks 48, 96, 156
|
Change from Baseline in C-Reactive Protein Values
Time Frame: Baseline (Week 0), Weeks 48, 96, 156
|
Baseline (Week 0), Weeks 48, 96, 156
|
Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab
Time Frame: Baseline up to 156 weeks
|
Baseline up to 156 weeks
|
Number of SC Tocilizumab Injections Administered
Time Frame: Baseline up to 156 weeks
|
Baseline up to 156 weeks
|
Total SC Tocilizumab Dose Administered
Time Frame: Baseline up to 156 weeks
|
Baseline up to 156 weeks
|
Duration of SC Tocilizumab Treatment
Time Frame: Baseline up to 156 weeks
|
Baseline up to 156 weeks
|
Duration of SC Tocilizumab Interruption
Time Frame: Baseline up to 156 weeks
|
Baseline up to 156 weeks
|
Duration Between Last Tocilizumab Administration in Study WA28119 and First Tocilizumab Administration in Current Study
Time Frame: From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline)
|
From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 25, 2017
Primary Completion (ACTUAL)
August 21, 2019
Study Completion (ACTUAL)
August 21, 2019
Study Registration Dates
First Submitted
June 27, 2017
First Submitted That Met QC Criteria
June 27, 2017
First Posted (ACTUAL)
June 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 4, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Vasculitis
- Skin Diseases, Vascular
- Vasculitis, Central Nervous System
- Polymyalgia Rheumatica
- Giant Cell Arteritis
- Arteritis
Other Study ID Numbers
- ML39425
- 2016-002716-41 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Giant Cell Arteritis
-
Matthew J KosterEli Lilly and CompanyCompleted
-
AbbVieActive, not recruitingGiant Cell Arteritis (GCA)United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, United...
-
University Hospital, Basel, SwitzerlandNovartis; Schweizerische Stiftung für die Erforschung der MuskelkrankheitenRecruitingPolymyalgia Rheumatica (PMR) | Giant Cell Arteritis (GCA)Switzerland
-
Centre Hospitalier Universitaire DijonRecruitingPatients Relapsing Refractory Giant Cell ArteritisFrance
-
Novartis PharmaceuticalsActive, not recruitingGiant Cell Arteritis (GCA)United States, Belgium, Hungary, Italy, Turkey, Austria, Spain, Switzerland, France, Germany, Israel, Australia, Denmark, Greece, United Kingdom, Guatemala, Bulgaria, Czechia, Estonia, Argentina, Canada, Brazil, Sweden, Finland, Poland, P... and more
-
University Hospital, LimogesTerminatedGiant Cell Arteritis in Dependency of ElderlyFrance
-
University Hospital, GrenobleTerminated
-
University Health Network, TorontoCompleted
-
University of OxfordUniversity of LeedsWithdrawnTemporal Arteritis
Clinical Trials on Tocilizumab
-
University of ChicagoActive, not recruiting
-
CelltrionNot yet recruiting
-
Hoffmann-La RocheCompletedCOVID-19Spain, Germany, United States, Brazil, Italy, France, Greece, Croatia, Poland, South Africa, United Kingdom
-
Sun Yat-sen UniversityWithdrawn
-
Fundacion SEIMC-GESIDARoche Pharma AG; Dynamic Science S.L.Completed
-
Hoffmann-La RocheCompleted
-
Hoffmann-La RocheCompletedRheumatoid ArthritisIndonesia
-
University of OklahomaHoffmann-La RocheNo longer availableJuvenile Idiopathic ArthritisUnited States
-
University of ChicagoRecruiting
-
Reade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingRheumatoid ArthritisNetherlands