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An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)

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ClinicalTrials.gov Identifier: NCT03202368
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: Tocilizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2018


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.
Drug: Tocilizumab
162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first
Other Name: RO4877533




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 160 weeks ]

Secondary Outcome Measures :
  1. GCA Disease Activity, as Assessed by the Investigator Based on Visual Analogue Scale Score [ Time Frame: Baseline (Week 0), Weeks 48, 96, 156 ]
  2. 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 ]
  3. Change from Baseline in Erythrocyte Sedimentation Rate Values [ Time Frame: Baseline (Week 0), Weeks 48, 96, 156 ]
  4. Change from Baseline in C-Reactive Protein Values [ Time Frame: Baseline (Week 0), Weeks 48, 96, 156 ]
  5. Number of Participants Who Receive Concomitant Medications With SC Tocilizumab [ Time Frame: Baseline up to 156 weeks ]
  6. Number of SC Tocilizumab Injections Administered [ Time Frame: Baseline up to 156 weeks ]
  7. Total SC Tocilizumab Dose Administered [ Time Frame: Baseline up to 156 weeks ]
  8. Duration of SC Tocilizumab Treatment [ Time Frame: Baseline up to 156 weeks ]
  9. Duration of SC Tocilizumab Interruption [ Time Frame: Baseline up to 156 weeks ]
  10. 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; will be assessed retrospectively at Baseline) ]
    Only participants who received SC tocilizumab in Part 1 or Part 2 of Study WA28119 will be analyzed.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202368


Contacts
Contact: Reference Study ID Number: ML39425 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
France
Hopital Avicenne; Medecine Interne H5 Not yet recruiting
Bobigny, France, 93009
Hopital La Cavale Blanche; Rhumatologie Active, not recruiting
Brest, France, 29609
Hopital Claude Huriez; Internal Medicine Active, not recruiting
Lille, France, 59037
Hopital Emile Muller; Medecine Interne Recruiting
Mulhouse, France, 68070
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03202368     History of Changes
Other Study ID Numbers: ML39425
2016-002716-41 ( EudraCT Number )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Giant Cell Arteritis
Polymyalgia Rheumatica
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases