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

September 2, 2020 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Hopital La Cavale Blanche; Rhumatologie
      • Lille, France, 59037
        • Hopital Claude Huriez; Internal Medicine
      • Mulhouse, France, 68070
        • Hopital Emile Muller; Medecine Interne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • RO4877533

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of subjects with Adverse Events
Time Frame: Baseline up to 160 weeks
Baseline up to 160 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Baseline up to 160 weeks
Time Frame: Baseline (Week 0), Weeks 48, 96, 156
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
Baseline (Week 0), Weeks 48, 96, 156
Change from Baseline in Erythrocyte Sedimentation Rate Values
Time Frame: Baseline (Week 0), Weeks 48, 96, 156
Baseline (Week 0), Weeks 48, 96, 156
Change from Baseline in C-Reactive Protein Values
Time Frame: Baseline (Week 0), Weeks 48, 96, 156
Baseline (Week 0), Weeks 48, 96, 156
Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab
Time Frame: Baseline up to 156 weeks
Baseline up to 156 weeks
Number of SC Tocilizumab Injections Administered
Time Frame: Baseline up to 156 weeks
Baseline up to 156 weeks
Total SC Tocilizumab Dose Administered
Time Frame: Baseline up to 156 weeks
Baseline up to 156 weeks
Duration of SC Tocilizumab Treatment
Time Frame: Baseline up to 156 weeks
Baseline up to 156 weeks
Duration of SC Tocilizumab Interruption
Time Frame: Baseline up to 156 weeks
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)
From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML39425
  • 2016-002716-41 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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