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

NCT03202368 | Completed Phase 3

• 2 other identifiers: ML394252016-002716-41
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with Adverse Events

  Baseline up to 160 weeks

Secondary Outcomes (10)

• Baseline up to 160 weeks

  Baseline (Week 0), Weeks 48, 96, 156

• Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score

  Baseline (Week 0), Weeks 48, 96, 156

• Change from Baseline in Erythrocyte Sedimentation Rate Values

  Baseline (Week 0), Weeks 48, 96, 156

• Change from Baseline in C-Reactive Protein Values

  Baseline (Week 0), Weeks 48, 96, 156

• Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab

  Baseline up to 156 weeks

Study Arms (1)

Tocilizumab: GCA Flare or Persistent Disease Activity

EXPERIMENTAL

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

Interventions

Tocilizumab DRUG

162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first

Also known as: RO4877533

Tocilizumab: GCA Flare or Persistent Disease Activity

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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
• Body weight of more than (\>) 150 kilograms
• 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
• Previous treatment with alkylating agents such as chlorambucil or with total lymphoid irradiation

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Hopital La Cavale Blanche; Rhumatologie

Brest, 29609, France

Location

Hopital Claude Huriez; Internal Medicine

Lille, 59037, France

Location

Hopital Emile Muller; Medecine Interne

Mulhouse, 68070, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: October 25, 2017
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

FR (3)