Ustekinumab for the Treatment of Giant Cell Arteritis

NCT02955147 | Terminated Phase 1 Results

• 1 other identifier: 2016P000932
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Giant Cell Arteritis; Temporal Arteritis; Horton's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients in Glucocorticoid-free Remission

  The primary study endpoint, prednisone-free remission, was defined as: 1) absence of relapse from the time that remission was achieved through week 52; 2) normalization of ESR (\<40 mm/hour) and CRP (\<10 mg/L); and, 3) adherence to the protocol prednisone taper.

  52 weeks

Secondary Outcomes (2)

• Number of Participants With Disease Flare

  52 weeks

• Cumulative Prednisone Dose

  52 weeks

Other Outcomes (1)

• Number of Participants With at Least One Adverse Event

  52 weeks

Study Arms (1)

Ustekinumab plus prednisone

EXPERIMENTAL

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.

Drug: Ustekinumab; Drug: Prednisone

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

Also known as: Stelara

Ustekinumab plus prednisone

Prednisone DRUG

Prednisone is an anti-inflammatory medication

Ustekinumab plus prednisone

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the study protocol
• Diagnosis of GCA classified according to the following criteria:
• Age 50 years or older
• History of erythrosedimentation rate (ESR) ≥ 50 mm/hour or C-reactive protein (CRP) ≥ 10 mg/L
• AND at least one of the following:
• Cranial symptoms of GCA
• Symptoms of polymyalgia rheumatica (PMR)
• 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
• Active new-onset or relapsing active disease

You may not qualify if:

• Allergies: Subjects who have history of previous severe allergic or anaphylactic reaction associated with the administration of monoclonal antibodies or antibody fragments.
• Systemic infection: Subjects who have an active systemic infection.
• Serious infection: Subjects who have had serious infections, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of enrollment.
• Chronic or recurrent infection: Subjects who have chronic or recurrent bacterial, viral, fungal, mycobacterial, or protozoan infection.
• Opportunistic infection: Subjects who have, or have had, an opportunistic infection within 6 months prior to enrollment.
• Subjects who have active hepatitis B or active hepatitis C or a documented history of HIV
• Latent tuberculosis infection
• Malignancy
• Subjects with evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, immunologic, psychiatric or gastrointestinal disease that could interfere with participation in the trial according to the protocol.
• Subjects with transplanted organs (with the exception of a corneal transplant \> 3 months prior to screening)
• Major surgery within 8 weeks prior to Screening or planned major surgery within 12 months after Baseline
• Pregnancy
• The following laboratory abnormalities
• Hemoglobin \< 8 gr/dL
• Platelets \< 100/mm3

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Matza MA, Fernandes AD, Stone JH, Unizony SH. Ustekinumab for the Treatment of Giant Cell Arteritis. Arthritis Care Res (Hoboken). 2021 Jun;73(6):893-897. doi: 10.1002/acr.24200.

  PMID: 32248659 DERIVED

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Ustekinumab; Prednisone

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Sebastian Unizony
• Organization: Mass General Hospital

sunizony@mgh.harvard.edu

(617) 726-7938

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 4, 2016
• Study Start: December 1, 2016
• Primary Completion: July 25, 2019
• Study Completion: September 19, 2019
• Last Updated: June 12, 2020
• Results First Posted: June 12, 2020

Record last verified: 2020-06

Locations

US (1)