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Ustekinumab for the Treatment of Giant Cell Arteritis (UGCA)

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ClinicalTrials.gov Identifier: NCT02955147
Recruitment Status : Terminated (Inefficacy)
First Posted : November 4, 2016
Results First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Sebastian H Unizony, MD, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Temporal Arteritis Horton's Disease Drug: Ustekinumab Drug: Prednisone Phase 1 Phase 2

Detailed Description:

The objective of this study is to evaluate the efficacy and safety of ustekinumab, an interleukin (IL)-12/23 inhibitor, in patients with GCA

Hypothesis IL-12/23 pathway blockade may maintain disease remission in patients with GCA

Specific Aims

  • To evaluate the safety and tolerability of ustekinumab administration in 20 patients with GCA
  • To evaluate the efficacy of ustekinumab for remission maintenance and glucocorticoid sparing in 20 patients with GCA

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : September 19, 2019


Arm Intervention/treatment
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.
Drug: Ustekinumab
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
Other Name: Stelara

Drug: Prednisone
Prednisone is an anti-inflammatory medication




Primary Outcome Measures :
  1. Percentage of Patients in Glucocorticoid-free Remission [ Time Frame: 52 weeks ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Disease Flare [ Time Frame: 52 weeks ]
    Disease relapse was defined as the recurrence of signs or symptoms of GCA (e.g., cranial or PMR) that required treatment intensification, regardless of the ESR and CRP levels.

  2. Cumulative Prednisone Dose [ Time Frame: 52 weeks ]

Other Outcome Measures:
  1. Number of Participants With at Least One Adverse Event [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Subjects must meet the following criteria

  1. Able and willing to provide written informed consent and to comply with the study protocol
  2. 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
  3. Active new-onset or relapsing active disease

Exclusion Criteria:

  1. Allergies: Subjects who have history of previous severe allergic or anaphylactic reaction associated with the administration of monoclonal antibodies or antibody fragments.
  2. Systemic infection: Subjects who have an active systemic infection.
  3. 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.
  4. Chronic or recurrent infection: Subjects who have chronic or recurrent bacterial, viral, fungal, mycobacterial, or protozoan infection.
  5. Opportunistic infection: Subjects who have, or have had, an opportunistic infection within 6 months prior to enrollment.
  6. Subjects who have active hepatitis B or active hepatitis C or a documented history of HIV
  7. Latent tuberculosis infection
  8. Malignancy
  9. 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.
  10. Subjects with transplanted organs (with the exception of a corneal transplant > 3 months prior to screening)
  11. Major surgery within 8 weeks prior to Screening or planned major surgery within 12 months after Baseline
  12. Pregnancy
  13. The following laboratory abnormalities

    • Hemoglobin < 8 gr/dL
    • Platelets < 100/mm3
    • White blood cell count (WBC) < 3000/mm3
    • Absolute neutrophil count < 2000/mm3
    • Absolute lymphocyte count < 500/mm3
    • Serum creatinine > 1.4 mg/dL in female subjects and > 1.6 mg/dL in male subjects
    • Total bilirubin > 2 mg/dL
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 X upper limit of normal
    • Positive hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody
  14. Prohibited medications:

    • Subjects who received methotrexate (MTX) > 30 mg weekly, azathioprine, mycophenolate mofetil, cyclophosphamide, chlorambucil, tacrolimus, leflunomide, canakinumab, belimumab, abatacept, tocilizumab, secukinumab, infliximab, etanercept, adalimumab, golimumab, or certolizumab within the 3-month period prior to enrollment.
    • Subjects who had treatment with any anti-cluster designation antigen (CD)20 agent (e.g., rituximab) within the 9-month period prior to enrolment
    • Subjects who used any investigational drug within 1 month prior to enrollment or within 5 half-lives of the investigational agent, whichever is longer.
    • Low dose MTX: Patients on < 30 mg of MTX weekly will be eligible for enrollment after a 2-week washout interval before receiving ustekinumab
    • Vaccines: Subjects who received any live virus or bacterial vaccinations other than bacille Calmette-Guerin (BCG) within the 3 months before the first administration of the study agent, or are expected to receive any live virus or live bacterial vaccinations during the study, or up to 3 month after the last administration of ustekinumab are not eligible. Subjects who received BCG vaccines within the 12 months before the first administration of the study agent, or are expected to receive BCG vaccines during the study, or up to 12 month after the last administration of ustekinumab are also not eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955147


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Sebastian H Unizony, MD, Massachusetts General Hospital:
Informed Consent Form  [PDF] June 14, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sebastian H Unizony, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02955147    
Other Study ID Numbers: 2016P000932
First Posted: November 4, 2016    Key Record Dates
Results First Posted: June 12, 2020
Last Update Posted: June 12, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Prednisone
Ustekinumab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Dermatologic Agents