Giant Cell ArteritisPhase 3NCT03202368
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
A Phase 3 study testing Tocilizumab in people with Giant Cell Arteritis, run by Hoffmann-La Roche at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Oct 2017to 21 Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who have prematurely withdrawn from the WA28119 core study for any reason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
Show all 28Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital La Cavale Blanche; Rhumatologie
Brest, 29609
Hopital Claude Huriez; Internal Medicine
Lille, 59037
Hopital Emile Muller; Medecine Interne
Mulhouse, 68070
About this study
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.
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
- Being tested
- Tocilizumab
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RO4877533
162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with Adverse Events
Measured: Baseline up to 160 weeks
Secondary outcomes (10)
Baseline up to 160 weeks
Measured: Baseline (Week 0), Weeks 48, 96, 156
Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score
Measured: Baseline (Week 0), Weeks 48, 96, 156
Change from Baseline in Erythrocyte Sedimentation Rate Values
Measured: Baseline (Week 0), Weeks 48, 96, 156
Change from Baseline in C-Reactive Protein Values
Measured: Baseline (Week 0), Weeks 48, 96, 156
Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab
Measured: Baseline up to 156 weeks
Number of SC Tocilizumab Injections Administered
Measured: Baseline up to 156 weeks
Total SC Tocilizumab Dose Administered
Measured: Baseline up to 156 weeks
Duration of SC Tocilizumab Treatment
Measured: Baseline up to 156 weeks
Duration of SC Tocilizumab Interruption
Measured: Baseline up to 156 weeks
Duration Between Last Tocilizumab Administration in Study WA28119 and First Tocilizumab Administration in Current Study
Measured: From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start25 Oct 2017
- Primary completion21 Aug 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202368
- Sponsor's protocol ID
- ML39425
- Other IDs
- 2016-002716-41, 2016
- Status last verified
- Sep 2020
- First submitted
- 27 Jun 2017
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03202368
- Acronym / sponsor ID
- ML39425
- Conditions
- Giant Cell Arteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab: GCA Flare or Persistent Disease Activity | Experimental | Drug: TocilizumabParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: RO4877533162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first | Drug | Tocilizumab: GCA Flare or Persistent Disease Activity |
Primary outcome
Percentage of subjects with Adverse Events
Time frame: Baseline up to 160 weeks
10 secondary outcomes
Baseline up to 160 weeks
Time frame: Baseline (Week 0), Weeks 48, 96, 156
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
Change from Baseline in Erythrocyte Sedimentation Rate Values
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Change from Baseline in C-Reactive Protein Values
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab
Time frame: Baseline up to 156 weeks
Number of SC Tocilizumab Injections Administered
Time frame: Baseline up to 156 weeks
Total SC Tocilizumab Dose Administered
Time frame: Baseline up to 156 weeks
Duration of SC Tocilizumab Treatment
Time frame: Baseline up to 156 weeks
Duration of SC Tocilizumab Interruption
Time frame: Baseline up to 156 weeks
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; assessed retrospectively at Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
Related trials for Giant Cell Arteritis
Recruiting
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica (PMR)
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
RecruitingPhase 3
Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Polymyalgia Rheumatica
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab in people with Giant Cell Arteritis, run by Hoffmann-La Roche at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with Adverse Events (time frame: Baseline up to 160 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.