Bewertung der Wirksamkeit und Sicherheit von Sarilumab bei Patienten mit Riesenzellarteriitis (RZA).

Trade Name: Kevzara ®
Product Name: NA
Product Code: [NA]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SARILUMAB
Current Sponsor code: SAR153191
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Kevzara ®
Product Name: na
Product Code: [na]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SARILUMAB
Current Sponsor code: SAR153191
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Cortancyl ® 5 mg
Product Name: NA
Product Code: [NA]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREDNISONE
Current Sponsor code: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Cortancyl ® 1 mg
Product Name: na
Product Code: [na]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREDNISONE
Current Sponsor code: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Cortancyl ® 20 mg
Product Name: NA
Product Code: [NA]
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
Current Sponsor code: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Cortancyl ® 5 mg
Product Name: NA
Product Code: [NA]
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
Curr

Inclusion criteria:
-Diagnosis of giant cell arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 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 (ESR) >/=30 mm/hour or C-reactive protein (CRP) >/=10 mg/L within 6 weeks of baseline.
-Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 127
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 381

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.