Giant cell arteritis (GCA) MedDRA version: 19.1 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000004866
Conditions
Interventions
Trade Name: RoActemra 162 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: T
Sponsors
ROCHE SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Able and willing to provide written informed consent and to comply with the requirements of the study protocol. 2.Patient who completed the 156-week WA28119 core study in France. 3.Patient who experienced at any time during WA28119 core study a clinical improvement based on the investigator’s judgment, and may continue to benefit from SC TCZ in this study. 4.Patient whom the investigator wants to treat with SC TCZ for one of the following reasons: •Persistent active GCA at the time of completion of the 156-week WA28119 core study. •New flare occurring within 3 years after completion of the 156-week WA28119 core study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.Patients who have prematurely withdrawn from the WA28119 core study for any reason 2.Major surgery within 8 weeks prior to screening or planned major surgery within the next 12 months 3.Major ischemic event, unrelated to GCA, within 12 weeks of inclusion 4.Transplanted organs (except corneal transplant performed more than 3 months prior to inclusion) 5.History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone 6.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 7.Current liver disease, as determined by the investigator (ie. Positive hepatitis B surface antigen or hepatitis C antibody) 8.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 patient to perforations 9.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) 10.Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of inclusion or oral antibiotics within 2 weeks of inclusion. 11.Active TB requiring treatment within the previous 3 years. Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years are eligible. 12.Primary or secondary immunodeficiency (history of or currently active) 13.Evidence of malignant disease or malignancies diagnosed since last WA28119 visit (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured) 14.Females of childbearing potential and females who are breastfeeding 15.Males 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. 16.History of alcohol, drug, or chemical abuse within 1 year prior to inclusion 17.Body weight > 150 kg Exclusion Related to Previous or Concomitant Therapy 18.Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of inclusion (except TCZ) 19.Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20 20.Treatment with IV gamma globulin or plasmapheresis within 6 months of inclusion 21.Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation 22.Immunization with a live/attenuated vaccine within = 4 weeks prior to inclusion 23.Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or MMF within 4 weeks of inclusion 24.Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of inclusion 25.Previous treatment with tofacitinib 26.Treatment with cyclophosphamide within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety of SC TCZ in patients who have completed the 156-week WA28119 two-part study in France and require SC TCZ according Investigator’s Judgment.;Secondary Objective: •To describe GCA disease activity based on the presence or absence of signs and symptoms. •To describe acute phase reactants erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values from inclusion. •To describe the concomitant treatments with SC TCZ for GCA. •To describe the administration of SC TCZ. •To describe the duration between the date of last SC TCZ administration in study WA28119 and the date of first SC TCZ administration in the extension study. ;Primary end point(s): Incidence, nature, and severity of adverse events ;Timepoint(s) of evaluation of this end point: Follow and assess during all the course of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 / All patients ‘characteristics at inclusion of the extension study will be described 2/Investigator’s assessment for disease activity will be described Patient’s VAS scale for GCA activity will be described 3/ Change from inclusion of the extension study in ESR, CRP value will be described 4 / Concomitant treatments with SC TCZ for GCA will be described by number of patients with TCZ monotherapy, TCZ combined with corticosteroid or TCZ combined with others 5/ SC TCZ administration will be described with number of injection, dose administered, duration of treatment and period of interruption 6/ Duration between the date of last SC TCZ administration in study WA28119 and the date of first SC TCZ administration in the extension study ;Timepoint(s) of evaluation of this end point: 1 / V1 2 / Wk48, Wk96, Wk156 or early withdrawal 3/ Wk48, Wk96, Wk156 or early withdrawal 4/ Follow and assess during all the course of the study. Secondary end point: 5/ Follow and assess during all the course of the study. 6/ V1 | — |
Countries
France
Contacts
Public ContactOpérations Cliniques/ Direction Med
ROCHE SAS
Outcome results
None listed