An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01791153
• Date of registration: 12/02/2013
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
• 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: July 22, 2013
• Target sample size: 251
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01791153
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of GCA classified according to age >/=50 years; history of ESR >/=50 mm/hr
or history of CRP >/=2.45 mg/dL; and at least one of the following: unequivocal
cranial symptoms of GCA or symptoms of polymyalgia rheumatica [PMR]; and at least one
of the following: temporal artery biopsy revealing features of GCA or evidence of
large-vessel vasculitis by angiography or cross-sectional imaging

- New onset (diagnosis within 6 weeks of baseline) or refractory (diagnosis greater than
[>] 6 weeks before baseline and previous treatment with >/= 40 milligrams per day
prednisone [or equivalent] for at least 2 consecutive weeks at any time) GCA

- Active disease (presence of clinical signs and symptoms [cranial or PMR] and ESR >/=30
mm/hour or CRP >/=1 mg/dL) within 6 weeks of baseline visit

Exclusion Criteria:

- Major surgery within 8 weeks prior to screening or planned within 12 months after
randomization

- Transplanted organs (except corneas with transplant performed >3 months prior to
screening)

- Major ischemic event, unrelated to GCA, 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;
cell-depleting therapies including investigational agent; intravenous (IV) gamma
globulin or plasmapheresis within 6 months of baseline; alkylating agents or with
total lymphoid irradiation; tocilizumab; hydroxychloroquine, cyclosporine A,
azathioprine, or mycophenolate mofetil within 4 weeks of baseline; etanercept within 2
weeks of baseline; infliximab, certolizumab, golimumab, abatacept, or adalimumab
within 8 weeks of baseline; anakinra within 1 week of baseline; tofacitinib;
cyclophosphamide within 6 months of baseline; >100 milligrams of daily IV
methylprednisolone within 6 weeks of baseline

- Participants requiring systemic glucocorticoids for conditions other than GCA, which,
in the opinion of the investigator, would interfere with adherence to the fixed
glucocorticoid taper regimen and/or to assessment of efficacy in response to the test
article

- History of severe allergic reactions to monoclonal antibodies or to prednisone

- Evidence of serious uncontrolled concomitant disease (for example, cardiovascular,
respiratory, renal, endocrine, psychiatric, corneal ulcers/injuries, or
gastrointestinal [GI] disease)

- Current liver disease, as determined by the investigator

- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract
condition that might predispose to bowel perforation

- Known active or history of recurrent bacterial, viral fungal, mycobacterial, or other
infection

- Primary or secondary immunodeficiency

- Evidence of malignancies diagnosed within previous 5 years (except basal and squamous
cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been
excised and cured)

- Inadequate hematologic, renal or liver function

- Positive for hepatitis B or hepatitis C infection



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Intervention(s)

Drug: Prednisone Placebo

Drug: Tocilizumab Placebo

Drug: Corticosteroids

Drug: Prednisone

Drug: Methotrexate

Drug: Tocilizumab

Primary Outcome(s)

Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) [Time Frame: Week 52]

Secondary Outcome(s)

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab [Time Frame: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])]

Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab [Time Frame: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])]

Total Cumulative Prednisone Dose [Time Frame: Up to 52 weeks]

Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52 [Time Frame: Baseline, Week 52]

Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper) [Time Frame: Week 52]

Percentage of Participants With Anti-Tocilizumab Antibodies [Time Frame: Baseline up to Week 52]

Serum Interleukin-6 (IL-6) Level [Time Frame: Baseline and Week 52]

C-Reactive Protein (CRP) Level [Time Frame: Baseline and Week 52]

Erythrocyte Sedimentation Rate (ESR) [Time Frame: Baseline and Week 52]

Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52 [Time Frame: Baseline, Week 52]

Minimum Observed Serum Concentration (Ctrough) of Tocilizumab [Time Frame: Predose (Hour 0) at Baseline and Week 52]

Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab [Time Frame: Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])]

Time to First GCA Disease Flare [Time Frame: Up to 52 weeks]

Serum Soluble IL-6 Receptor (sIL-6R) Level [Time Frame: Baseline and Week 52]

Secondary ID(s)

2011-006022-25

WA28119

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01791153