A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.

• Register: EUCTR
• Last refreshed on: 11 June 2018
• Main ID: EUCTR2011-006022-25-BE
• Date of registration: 17/06/2013
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.
• Scientific title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS
• Date of first enrolment: 30/09/2013
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006022-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Diagnosis of GCA classified according to the following criteria:
• Age greater than or equal to 50 years
• History of ESR (greater than 50 mm/hour)
• AND at least one of the following:
• Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
• Symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness
• AND at least one of the following:
• Temporal artery biopsy revealing features of GCA
• Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography computed tomography angiography (PET-CT)
New-onset or refractory active disease defined as follows:
• New onset: diagnosis of GCA within 6 weeks of baseline visit
• Refractory: diagnosis of GCA >6 weeks before baseline visit and previous treatment with =40 mg/day prednisone (or equivalent) for at least 2 consecutive weeks at any time
AND
Active GCA within 6 weeks of baseline visit (active disease defined as the presence of clinical signs and symptoms [cranial or PMR] and ESR greater than or equal to 30 mm/hour or CRP greater than or equal to 1 mg/dL)

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion criteria:
- Recent or incoming major surgery
- Organ transplantation recipient (except corneas within 3 months prior to baseline visit)
- Major ischemic event, unrelated to giant cell arteritis, within 12 weeks of screening
- Prior treatment with any of the following:
- Investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening visit
- Cell-depleting agents (e.g. anti CD 20)
- Tocilizumab
- Tofacitinib
- Alkylating agents including CYC within 6
months of baseline
- HCQ, CsA, AZA, or MMF within 4 weeks
of baseline
- Tumor necrosis factor inhibitors within 2-8 weeks of baseline
- Anakinra within 1 week of baseline
- Corticosteroids for conditions other than
GCA
- IV corticosteroids within 6 weeks of
baseline
- History of severe allergic reactions to
monoclonal antibodies
- Evidence of serious uncontrolled
concomitant disease (e.g. cardiovascular,
respiratory, renal, endocrine)
- Current liver disease that could interfere
with the trial as determined by the
investigator
- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation
- Infections:
- Active current or history of recurrent
bacterial, viral fungal, mycobacterial, or
other infection



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Giant cell arteritis (GCA)
MedDRA version: 20.0 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000013753

Intervention(s)

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: RO4877533
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: PredniSONE Tablets USP, 1 mg
Product Code: Ro 001-9265/F02
Pharmaceutical Form: Capsule
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: PredniSONE Tablets USP, 2.5 mg
Product Code: Ro 001-9265/F03
Pharmaceutical Form: Capsule
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: PredniSONE Tablets USP, 5 mg
Product Code: Ro 001-9265/F04
Pharmaceutical Form: Capsule
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Encorton
Product Code: Ro 001-9265
Pharmaceutical Form: Tablet
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Secondary Objective: To evaluate
•efficacy of TCZ in combination with a 26-wk prednisone taper regimen vs placebo in combination with the 52-wk prednisone taper regimen, in pts with GCA, as measured by the proportion of pts in sustained remission at Wk 52 following induction and adherence to the protocol-defined prednisone taper regimen
•efficacy of TCZ in combination with a 26-wk prednisone taper regimen vs both placebo groups, in pts with GCA, as measured by the following:
-Time to GCA disease flare after clinical remission
-Cumulative CS dose
•effect on pts QoL of TCZ in combination with a 26-wk prednisone taper regimen vs both placebo groups, in pts with GCA, based on the patient-reported outcome as measured by SF-36 and patient global assessment of disease activity on a visual analogue scale
•PK and PD of TCZ in combination with a 26-wk prednisone taper regimen in pts with GCA
•safety, tolerability, immunogenicity of TCZ in combination with a 26-wk prednisone taper regimen in pts with GCA

Main Objective: To evaluate the efficacy of tocilizumab (TCZ) compared to placebo, in combination with a 26 week prednisone taper regimen, in patients with giant cell arteritis (GCA), as measured by the proportion of patients in sustained remission at Week 52 following induction and adherence to the protocol-defined prednisone taper regimen

Primary end point(s): The primary efficacy endpoint is the proportion of patients in sustained remission at Week 52

Timepoint(s) of evaluation of this end point: 52 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 52 weeks

Secondary end point(s): - The proportion of patients in sustained remission at Week 52 in the TCZ treatment groups versus the placebo group with 52-week prednisone taper
- Time to first GCA disease flare after clinical remission (up to 52 weeks)
- Summary of total cumulative prednisone dose over 52 weeks
- Change from baseline in SF-36 (Physical and Mental Component Summaries) at 52 weeks
- Change from baseline in PGA of disease activity (VAS scale) at 52 weeks

Secondary ID(s)

WA28119

NCT01791153

2011-006022-25-IT

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.