Ustekinumab for the Treatment of Giant Cell Arteritis
Stopped early · Phase 1/Phase 2
Conditions studied: Giant Cell Arteritis, Temporal Arteritis, Horton's Disease
In brief
The purpose of this study is to determine whether ustekinumab is effective in the treatment of Giant Cell Arteritis (GCA)
Key facts
- Study ID
- NCT02955147
- Run by
- Massachusetts General Hospital
- People needed
- 13
- Starts
- 2016-12-01
- Expected to finish
- 2019-09-19
- Last updated by the study team
- 2020-06-12
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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