A phase III, multicenter, randomized, double-blind placebo-controlled study to assess the efficacy and safety of Tocilizumab in subjects with giant cell arteritis.

Phase 3

Completed

Conditions: Giant Cell Arteritis
Temporal Arteritis
10027665

Registration Number: NL-OMON39663

Lead Sponsor: Hoffmann-La Roche

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- Able and willing to provide written informed consent and to comply with the study protocol
- Diagnosis of GCA
- New-onset or refractory active disease

Exclusion Criteria

- Major surgery within 8 weeks prior to screening or planned major surgery within 12 months after randomization
- Transplanted organs (except corneal transplant performed more than 3 months prior to screening)
- Major ischemic event, unrelated to GCA, within 12 weeks of screening
- Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20
- Treatment with IV gamma globulin or plasmapheresis within 6 months of baseline
- Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation
- Previous treatment with TCZ
- Immunization with a live/attenuated vaccine within <= 4 weeks prior to baseline
- Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or MMF within 4 weeks of
Baseline
- Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of baseline
- Previous treatment with tofacitinib
- Treatment with cyclophosphamide within 6 months of baseline
- Patients requiring systemic CS for other conditions other than GCA, which, in the opinion of the investigator, would interfere with adherence to the fixed CS taper regimen and/or to assessment of efficacy in response to the test article
- Chronic use of systemic CS for > 4 years or inability, in the opinion of the investigator, to withdraw CS treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency
- Receipt of > 100 mg daily intravenous methylprednisolone within 6 weeks of baseline
- Active TB requiring treatment within the previous 3 years
- Females of childbearing potential and females who are breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy Outcome Measures:<br /><br>1) Assessment of GCA disease activity based on the presence or absence of signs<br /><br>and symptoms<br /><br>2) Assessment of acute phase reactants ESR and CRP<br /><br>3) Assessment of prednisone dose and duration</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety Outcome Measures:<br /><br>1) Incidence, nature, and severity of adverse events<br /><br>2) Laboratory abnormalities including but not limited to neutropenia, liver<br /><br>function test abnormalities, thrombocytopenia, and lipid level abnormalities<br /><br>3) Incidence of anti-TCZ antibodies<br /><br><br /><br>Pharmacodynamic Outcome Measures:<br /><br>1) IL-6<br /><br>2) sIL-6R<br /><br>3) ESR and CRP<br /><br><br /><br>Pharmacokinetic Outcome Measures:<br /><br>1) TCZ concentration<br /><br>2) Derived PK parameters as follows:<br /><br>- AUC*, Cmax, and Cmin at steady state for 162 mg qw and 162 mg q2w for<br /><br>patients in the PK substudy<br /><br>- Predose TCZ concentration (Ctrough) for all patients<br /><br><br /><br>Patient-Reported Outcome Measures:<br /><br>1) PGA (VAS)<br /><br>2) SF-36<br /><br>3) EQ-5D<br /><br>4) FACIT-Fatigue</p><br>