a study of rhumab ifnalpha in adults with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this is a phase i, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhumab ifnalpha, administered through the sc or iv route, in adults with systemic lupus erythematosus.


Eligibility criteria:
inclusion criteria: * for patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study * diagnosis of sle according to current american college of rheumatology (acr) criteria * disease duration of ≥ 1 year (after first diagnosis by a physician) * current immunity to measles, mumps, rubella, and varicella, as evidenced by positive igg titers at the time of screening * current vaccination against influenza unless contraindicated in the investigator's judgment * normal pap smear within the applicable time interval recommended by current american cancer society guidelines exclusion criteria: * presence of active lupus nephritis * presence of active central nervous system (cns) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents * presence of active vasculitis requiring treatment * history of arterial or venous thromboses within 12 months of screening * moderate to severe anemia, thrombocytopenia, or neutropenia * any manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial * pregnancy or lactation * lack of peripheral venous access * history of alcohol or substance abuse within 6 months of screening * history of severe allergic or anaphylactic reactions to antibodies or fusion proteins * evidence of significant uncontrolled concomitant diseases * significant laboratory or electrocardiogram (ecg) abnormalities * evidence of any clinically significant abnormality on a chest x-ray * severly impaired renal function * impaired hepatic function * poorly controlled diabetes * conditions other than sle that could require treatment with corticosteroids * history of malignancy except completely excised basal cell carcinoma * congenital immune deficiency * positive tests for antibodies to hiv, hepatitis b (hbs antigen, anti-hbc) or c * positive igm antibody titers in the presence of negative igg titers to epstein-barr virus (ebv) or cytomegalovirus (cmv) * frequent recurrence of herpes lesions * episode of shingles within one year of screening * positive screening test for latent mycobacterium tuberculosis infection * history of severe systemic bacterial, fungal, viral, or parasitic infections within the year prior to screening * any current or recent signs or symptoms of infection * received antibiotics orally (po) during the 30 days prior to screening or iv antibiotics during the 60 days prior to screening * received a live vaccine within the 30 days prior to screening * has been hospitalized within the 30 days prior to screening * received \> 20 mg/day prednisone for \> 3 days during the 30 days prior to screening * received azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, pulse dose corticosteroids, intravenous immunoglobulin (ivig), or transfusions within 6 months prior to screening * received cyclophosphamide within 2 years prior to screening * received a monoclonal antibody during the 12 months prior to screening * previously received an investigational treatment directed against interferon alpha * received b-cell depleting therapy (e.g., anti-cd20, anti-cd22) * received investigational treatment during the 30 days prior to screening

Keywords: sle