Monoclonal Antibody Treatment for Systemic Lupus Erythematosus

Completed · Phase 1

Conditions studied: Systemic Lupus Erythematosus

In brief

This study will examine the safety and effects of the monoclonal antibody MRA in patients with systemic lupus erythematosus (SLE). Antibodies normally fight invading organisms. In autoimmune diseases, such as lupus, however, antibodies attack the body s own tissues. MRA is an antibody manufactured in the laboratory that blocks the action of interleukin-6 (IL-6), a substance that increases antibody production and is involved in inflammation that may cause organ damage in SLE. Patients 18 years of age and older with moderately active systemic lupus erythematosus may be eligible for this 6-month study. Candidates will be screened with blood and urine tests, chest X-ray, electrocardiogram (EKG), and screening tests for certain cancers. Participants will receive a total of up to seven infusions of MRA given every 2 weeks in the clinic. The MRA is infused over a period of about 1 hour through a catheter (thin plastic tube) inserted into an arm vein. Patients will be observed for 1 to 2 hours after each infusion for drug side effects. For the first and last infusions, patients will return to the clinic for blood tests 24 to 48 hours after the infusion. Additional tests may be done if medically indicated. Three different doses of MRA will be used in three groups of patients. The first group (4 patients) will receive the lowest dose. If this dose is well tolerated, a second group (6 patients) will receive a higher dose. If this dose is also well tolerated, a third group (6 patients) will receive the highest study dose. Patients will be evaluated at various intervals for up to 3 months after the last dose of MRA. The follow-up visits will include a review of the patient s medical history, a physical examination, blood and urine tests, and an EKG.

Key facts

Study ID

NCT00046774

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

23

Starts

2002-09-02

Expected to finish

2017-09-07

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test at screening.
• Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control during and for a period of three months after the completion of the study
• Any therapy with human or murine antibodies or any experimental therapy within 3 months
• Therapy with cyclophosphamide; pulse methylprednisolone or IV Ig within 4 weeks; or azathioprine, mycophenolate mofetil, cyclosporine or methotrexate within 2 weeks of first study treatment
• Initiation or a change in the dose of an ACE-inhibitor within 2 weeks of first study treatment
• Allergy to murine or human antibodies
• History of anaphylaxis
• Serum creatinine greater than 3.0 mg/dL
• Active severe CNS lupus (encephalopathy, cerebrovascular accident, transverse myelitis, severe depression, psychosis)
• Previous history of ischemic heart disease or evidence of ischemic heart disease on ECG
• Congestive heart failure or cardiomyopathy
• History of thrombosis or recurrent 2nd trimester abortions (3 or more) and elevated levels of anti-cardiolipin antibodies or lupus anticoagulant unless the patient is on anticoagulation
• History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix within the last 3 years
• Active infection that requires the use of intravenous antibiotics and does not resolve within 1 week of Day 1
• Any active viral infection that does not resolve within 10 days prior to Day 1
• History of reactivation on EB viral infection or greater than 1,000 EBV genome equivalent/10(6) cells in PBMC preparations
• Active hepatitis B, hepatitis C or HIV infection
• WBC less than 3500/microL or ANC less than 3000/microL or Hgb less than 8.0 g/dL or platelets less than 50,000/microL or absolute lymphocyte count less than or equal to 500/microL.
• ALT and/or AST greater than 2 times the upper limit of normal (ULN) or alkaline phosphatase greater than 1.5 times the ULN
• Significant concurrent medical condition that, in the opinion of the principal investigator, could affect the patient's ability to tolerate or complete the study
• Live vaccines within 4 weeks of first infusion

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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