Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
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ClinicalTrials.gov Identifier: NCT03600805 |
Recruitment Status :
Terminated
(Protracted recruitment timeline exacerbated by COVID-19 pandemic)
First Posted : July 26, 2018
Last Update Posted : December 28, 2020
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Primary Objective:
To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.
Secondary Objective:
- To demonstrate the efficacy of sarilumab in patients with GCA compared to placebo, in combination with CS taper with regards to:
- Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
- Cumulative CS (including prednisone) exposure.
- To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with GCA.
- To measure sarilumab serum concentrations in patients with GCA.
- To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Giant Cell Arteritis | Drug: Sarilumab SAR153191 Drug: Sarilumab matching placebo Drug: Prednisone Drug: Prednisone matching placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis |
Actual Study Start Date : | November 20, 2018 |
Actual Primary Completion Date : | November 24, 2020 |
Actual Study Completion Date : | November 24, 2020 |

Arm | Intervention/treatment |
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Experimental: Group A
Sarilumab dose 1, once every 2 weeks plus 26-week prednisone taper regimen
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Drug: Sarilumab SAR153191
Pharmaceutical form:solution for injection Route of administration: subcutaneous Drug: Prednisone Pharmaceutical form:tablets or capsules Route of administration: oral administration Drug: Prednisone matching placebo Pharmaceutical form:capsules Route of administration: oral administration |
Experimental: Group B
Sarilumab dose 2, once every 2 weeks plus 26-week prednisone taper regimen
|
Drug: Sarilumab SAR153191
Pharmaceutical form:solution for injection Route of administration: subcutaneous Drug: Prednisone Pharmaceutical form:tablets or capsules Route of administration: oral administration Drug: Prednisone matching placebo Pharmaceutical form:capsules Route of administration: oral administration |
Placebo Comparator: Group C
Sarilumab matching placebo once every 2 weeks plus prednisone regimen 26 weeks
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Drug: Sarilumab matching placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous Drug: Prednisone Pharmaceutical form:tablets or capsules Route of administration: oral administration Drug: Prednisone matching placebo Pharmaceutical form:capsules Route of administration: oral administration |
Placebo Comparator: Group D
Sarilumab matching placebo once every 2 weeks plus prednisone regimen 52 weeks
|
Drug: Sarilumab matching placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous Drug: Prednisone Pharmaceutical form:tablets or capsules Route of administration: oral administration Drug: Prednisone matching placebo Pharmaceutical form:capsules Route of administration: oral administration |
- Proportion of patients with sustained remission [ Time Frame: At Week 52 ]Proportion of patients achieving sustained remission at Week 52.
- Components of sustained remission (composite measure) [ Time Frame: At Week 52 ]Summary of the components of the sustained remission composite measure at Week 52
- Cumulative corticosteroid dose [ Time Frame: Up to Week 52 ]Total cumulative corticosteroid (including prednisone) dose over 52 weeks
- Time to first GCA flare [ Time Frame: Up to Week 52 ]Duration of first GCA flare from clinical remission up to Week 52
- Change in glucocorticoid toxicity index [ Time Frame: Up to Week 52 ]Changes from baseline in the glucocorticoid toxicity index and its components up to Week 52
- Adverse events [ Time Frame: Up to Week 76 ]Number of adverse events
- Pharmacokinetic [ Time Frame: Up to Week 58 ]Serum concentrations of sarilumab

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- Diagnosis of giant cell arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology classification criteria.
- New onset active disease or refractory active disease.
- At least one of the symptoms of GCA within 6 weeks of baseline.
- Either erythrocyte sedimentation rate ≥30 mm/hour or C-reactive protein ≥10 mg/L within 6 weeks of baseline.
- Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
Exclusion criteria:
- Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).
- Major ischemic event, unrelated to GCA, within 12 weeks of screening.
- Any prior use of the following therapies, for the treatment of GCA:
- Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
- Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to baseline level.
- Abatacept within 8 weeks of baseline.
- Anakinra within 1 week of baseline.
- Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half-lives have elapsed prior to baseline, whichever is longer.
- Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6/(R) antagonist (prior experience with IL-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
- Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
- Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine, mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and have been stable for at least 3 months prior to baseline is not exclusionary).
- Concurrent use of systemic corticosteroids (CS) for conditions other than GCA.
- Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.
- Pregnant or breastfeeding woman.
- Patients with active or untreated latent tuberculosis.
- Patients with history of invasive opportunistic infections.
- Patients with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
- Patients with uncontrolled diabetes mellitus.
- Patients with non-healed or healing skin ulcers.
- Patients who received any live, attenuated vaccine within 3 months of baseline.
- Patients who are positive for hepatitis B, hepatitis C and/or HIV.
- Patients with a history of active or recurrent herpes zoster.
- Patients with a history of or prior articular or prosthetic joint infection.
- Prior or current history of malignancy.
- Patients who have had surgery within 4 weeks of screening or planned surgery during study.
- Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation..
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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): NCT03600805

Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT03600805 |
Other Study ID Numbers: |
EFC15068 2017-002988-18 ( EudraCT Number ) U1111-1200-2184 ( Other Identifier: UTN ) |
First Posted: | July 26, 2018 Key Record Dates |
Last Update Posted: | December 28, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Polymyalgia Rheumatica Giant Cell Arteritis 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 Prednisone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |