Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT03745586
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Day 3: Tocilizumab infusion (8mg/kg body-weight) Day 10- week 52: Tocilizumab s.c. injections (162mg) in weekly intervals
  • Glucocorticoids — DRUG
    Day0-day2: methylprednisolone 500mg i.v.

Study Details

Two recent RCTs showed the ability of tocilizumab to induce and maintain remission of giant cell arteritis. Both studies used the dosing schemes for Rheumatoid Arthritis (i.e. 8mg/kg bodyweight i.v. in 4-weekly intervals and 162mg weekly s.c., respectively). In both trials glucocorticoids (GC) were initially administrated at medium to high doses with subsequent rapid reduction and discontinuation over 24 weeks. In case of relapse, GC doses were re-increased. The results of both studies suggest that GC could be reduced more rapidly. This would further reduce GC-induced adverse effects. Thus, the investigators propose to perform an open label single arm study to assess the efficacy of ultra-short co-medication with GC, using Simon's minimax two-stage design.

Key Dates

Start date
Dec 1, 2018
Status verified
Jun 2021
Primary completion
Nov 30, 2020
Completion
Mar 1, 2021

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All study participants

Primary Outcome Measure

Remission [ Time Frame: Week 24 ]

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