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Trial record 1 of 1 for:    03600805
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Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

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ClinicalTrials.gov Identifier: NCT03600805
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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

Detailed Description:
Study duration per participant is approximately 82 weeks, including an up to 6-week screening period, 52-week treatment period, and 24-week follow-up period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 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
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
Experimental: Group A
Sarilumab dose 1, 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

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
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




Primary Outcome Measures :
  1. Proportion of patients with sustained remission [ Time Frame: At Week 52 ]
    Proportion of patients achieving sustained remission at Week 52.


Secondary Outcome Measures :
  1. Components of sustained remission (composite measure) [ Time Frame: At Week 52 ]
    Summary of the components of the sustained remission composite measure at Week 52

  2. Cumulative corticosteroid dose [ Time Frame: Up to Week 52 ]
    Total cumulative corticosteroid (including prednisone) dose over 52 weeks

  3. Time to first GCA flare [ Time Frame: Up to Week 52 ]
    Duration of first GCA flare from clinical remission up to Week 52

  4. 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

  5. Adverse events [ Time Frame: Up to Week 76 ]
    Number of adverse events

  6. Pharmacokinetic [ Time Frame: Up to Week 58 ]
    Serum concentrations of sarilumab



Information from the National Library of Medicine

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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 :

  • 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.


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): NCT03600805


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03600805     History of Changes
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: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
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