Ustekinumab for the Treatment of Giant Cell Arteritis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02955147
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Giant Cell Arteritis
  • Horton's Disease
  • Temporal Arteritis

Eligibility Criteria

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

Interventions

  • Ustekinumab — DRUG
    Ustekinumab is a humanized monoclonal antibody that targets the p40 subunit of IL-12 and IL-23 and inhibits cytokine - cytokine receptor coupling and signaling
  • Prednisone — DRUG
    Prednisone is an anti-inflammatory medication

Study Details

The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)

Key Dates

Start date
Dec 1, 2016
Status verified
Jun 2020
Primary completion
Jul 25, 2019
Completion
Sep 19, 2019

Study Design

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

Arms

  • Experimental: Ustekinumab plus prednisone
    1. Ustekinumab: 90 mg of ustekinumab will be administered subcutaneously at baseline, week 4, week 12, week 20, week 28, week 36 and week 44. 2. Prednisone: All patients will receive a prednisone course tapered according to predefined schedules starting at either 60 mg, 40 mg or 20 mg. The initial dose of prednisone will be chosen by the investigators according to disease severity and comorbid medical conditions. The duration of the prednisone taper will be 6 months in all cases.

Primary Outcome Measure

Percentage of Patients in Glucocorticoid-free Remission [ Time Frame: 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies