E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Giant cell arteritis (GCA) |
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E.1.1.1 | Medical condition in easily understood language |
An inflammatory disease of the blood vessels that typically occurs in individuals over 50 years of age. It can cause fever, headache, jaw or mouth pain and can lead to irreversible vision loss |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018250 |
E.1.2 | Term | Giant cell arteritis |
E.1.2 | System Organ Class | 100000004866 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
•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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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 6 months of inclusion 27.Patients requiring systemic CS for other conditions other than GCA, which, in the opinion of the investigator, would interfere with the assessments of the protocol. 28.Receipt of > 100 mg daily intravenous methylprednisolone within 6 weeks of inclusion
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence, nature, and severity of adverse events
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Follow and assess during all the course of the study. |
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E.5.2 | 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
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E.5.2.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LPLV (160 weeks from inclusion in the extension study (including one follow-up call 4 weeks after last study drug administration) or when the SC formulation of TCZ becomes commercially available for GCA, whichever comes first)enter information in English and add any other language that is applicable |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |