Systemic Lupus Erythematosus Classification code 10042945
Conditions
Sponsors
Immunomedics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female, 18 years and older; -Signed written informed consent obtained prior to study entry; -Has SLE by American College of Rheumatology revised criteria (meets at least 4 criteria); -Has a positive ANA at study entry; -Has new onset of BILAG index A level activity in at least one body/organ system outside the renal and CNS systems; -If initiated corticosteroids for the current flare, any increase of more than 10 - 15 mg/day prednisone (or equivalent) must occur no more than 14 days prior to the anticipated date to begin first infusion of study drug; -If on immunosuppressives, must have been receiving immunosuppressives for at least 8 weeks, with a stable dose regimen for at least 4 weeks prior to study entry; and -If on antimalarials, must have been receiving antimalarials for at least 12 weeks, with a stable dose regimen for at least 4 weeks prior to study entry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test; -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 6 months after the completion of the study; -Active severe CNS disease; -Active severe renal disease; -Treatment with Lymphostat B, or CTLA4-Ig within 6 months, or with rituximab or other anti-B-cell ABs within 12 months; -Allergy to murine or human ABs; -Experimental therapy or any therapy with human or murine ABs within 3 months; Cyclophosphamide, cyclosporin, intravenous, joint or IM injections of corticosteroids exceeding 120 mg methylprednisolone, 60 mg triamcinolone, or equivalent; IV immunoglobulins, or any IMPs within 4 weeks; -Thrombosis, spontaneous or induced abortion, stillbirth or live birth, within 4 weeks; -Patients with antiphospholipid ABs AND a history of thromboembolic events; -On oral anticoagulants within 4 weeks; -History of malignancy (except basal or squamous cell carcinoma, cervical CIS); -Active infection receiving antibiotics within 7 days of screening or infection requiring hospitalization or herpes zoster treatment within 4 weeks; long-term infectious diseases (tuberculosis, fungal infections) active within 2 years; -Known HIV, hepatitis B or C infection, or other immunosuppressive states; -Live vaccine within 4 weeks; -Hematological abnormalities not attributed to lupus; -Liver transaminases or alkaline phosphatase > 3X upper limit of normal and not attributed to SLE; -Serum creatinine > 2.5 mg/dL or clinically significant increases within 4 weeks, or proteinuria > 3.5 mg/day; and -Substance abuse or other concurrent medical conditions that, in the investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to demonstrate that epratuzumab is effective in the treatment of acute lupus flare. ;Secondary Objective: -To evaluate the effectiveness of epratuzumab in treating severe disease activity (acute flare) and in maintaining disease control -To evaluate the ability of epratuzumab to reduce the use of corticosteroids and other lupus medications. -To demonstrate the safety of epratuzumab in patients with SLE. -To assess the effect of adding epratuzumab to standard care on the quality of life of patients with SLE. Supplemental endpoints: -Time-to-reflare (new/recurrent BILAG A or B) among patients with no BILAG index B (or A) scores in any body/organ system at 4 weeks as well as the proportion of patients with these reflares. -Proportion of patients able to maintain successful steroid-tapering from week 24 to 48.;Primary end point(s): The primary efficacy endpoint evaluated at 24 weeks is a patient response variable with three ordered categories; complete response (CR), partial response (PR) and non-response (NR). In order to be given a response status of CR or PR, a patient must meet two minimum conditions: (i) not be considered a treatment failure and (ii) not have any BILAG Index A score in any body/organ system at any post-treatment evaluation time-point from weeks 4 to 24. In addition, if the patient also satisfies the protocol-defined steroid-tapering criterion at 24 weeks and does not have any BILAG Index B score, in any body/organ system at any post-treatment evaluation time-point from weeks 4 to 24, the patient will be assigned a CR status. Otherwise, the patient will be assigned a PR status provided the two minimum conditions are satisfied. Requirements for CR and PR are summarized in the protocol (page 22). A patient who fails to meet the two minimum conditions will be assigned a NR status. | — |
Countries
Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed