A STUDY TO EVALUATE LONG TERM SAFETY OF TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE
- Conditions
- Giant cell arteritis (GCA)MedDRA version: 19.1Level: LLTClassification code 10018250Term: Giant cell arteritisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-002716-41-FR
- Lead Sponsor
- ROCHE SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
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
1.Patients who have prematurely withdrawn from the WA28119 core study for any reason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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>•To describe acute phase reactants erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values from inclusion.<br>•To describe the concomitant treatments with SC TCZ for GCA.<br>•To describe the administration of SC TCZ.<br>•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.<br>;Primary end point(s): Incidence, nature, and severity of adverse events<br><br>;Timepoint(s) of evaluation of this end point: Follow and assess during all the course of the study.
- Secondary Outcome Measures
Name Time Method