systemic lupus erythematosus MedDRA version: 9.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus
Conditions
Interventions
Product Name: epratuzumab
Product Code: CDP3194
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: epratuzumab
CAS Number:
Sponsors
UCB Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. SL0007 patients completing week 12 and patients early terminating at study week 8 (Visit 8) or later due to treatment failure as described in the SL0007 protocol. 2. Patients who completed study SL0007 must have maintained eligibility requirements (including concomitant medication restrictions) throughout their participation in the SL0007 study. Patients who terminated study SL0007 early due to use of restricted concomitant Lupus medications (e.g. increased corticosteroid dose) resulting in treatment failure may be eligible to enter SL0008. These patients should be discussed with the medical monitor on a case by case basis. 3. Written informed consent signed prior to the initiation of any study-specific assessments at Visit 1 (patients who will be participating in SL0008 must sign informed consent for study SL0008 prior to receiving any assessments for the last visit of SL0007 as data from this visit will be used for both studies). 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: 1. Active, severe neuropsychiatric SLE including but not limited to BILAG A criteria as follows: existing aseptic meningitis, cerebral vasculitis, demyelination syndromes (including ascending or transverse myelitis and acute inflammatory demyelinating polyradiculoneuropathy), myelopathy, acute confusional state, impaired level of consciousness, psychosis, cranial neuropathy, plexopathy, grand mal seizure, status epilepticus, cerebellar ataxia, stroke or stroke syndrome, chorea or any other severe neurologic condition which, in the opinion of the investigator, would prevent the subject from completing protocol required procedures. Mononeuritis multiplex is NOT excluded provided it is not new (within the past 4 weeks). 2. Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine > 2.5mg/dL or clinically significant (per investigator judgment) serum creatinine increasde within the 4 weeks prior to Visit 1 or proteinuria > 3.5gm/day. 3. Female subjects who are pregnant or lactating. Women of childbearing potential are required to have a negative pregnancy test at Visit 1 prior to the first dose of study medication. A urine pregnancy test will be completed every 4 weeks for the duration of the trial and must be negative in order for the subject to continue in the trial. Women of childbearing potential must use an acceptable method of birth control during the study and for a period of 3 months after the last dose of study medication (oral contraceptives must be stable for at least one full month prior to Visit 1). Abstinence alone or condoms/diaphragm use without adjunct spermacide are not an acceptable method of contraception for the study. Use of barrier contraception is acceptable, including double barrier methods and the single-barrier methods of diaphragm with adjunct spermacide or condom with adjunct spermacide. Females not receiving birth control must be surgically sterile, postmenopausal for at least 2 years prior to Visit 1, or must have undergone tubal ligation. 4. Evidence of an immunosuppressive state including HIV infection, agammaglobulinemias, T-cell deficiencies or HTLV-1 infection at any time prior to or during the study. 5. Patients with a history of chronic infections including, but not limited to hepatitis B or C. Patients with a history of a recent, serious or life-threatening infection (e.g. pneumonia or herpes zoster) or any current sign or symptoms that may indicate a significant infection at Visit 1 as per the Investigator’s clinical judgment. Patients must have completed any antibiotics prior to the first dose of study medication. 6. Patients who in the opinion of the investigator are at a particularly increased risk of developing a serious infection due to their lifestyle, occupational or social contacts. 7. Substance abuse/dependence or other concurrent medical conditions that could confound study interpretation or affect the patient’s ability to tolerate or complete the study. 8. Patients may not receive any live (or live attenuated) vaccines during the course of the study. 9. Use of oral anticoagulants or anti-platelet treatment regardless of indication or route (not including NSAIDS) within the 4 weeks prior to Visit 1. 10. Patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: continue to assess the safety of epratuzumab dosed at 1200mg bi-weekly for a total of two doses in 12-week re-treatment cycles in moderate to severe systemic lupus patients.; Secondary Objective: - continue to assess the tolerability of epratuzumab. - continue to assess the efficacy of epratuzumab. - continue to assess the kinetics and attributes of B and T cells in circulation. - continue to assess the pharmacokinetics, pharmacodynamics and immunogenicity of epratuzumab. - continue to assess the health-related quality of life benefits of epratuzumab treatment. - continue to assess the utility benefits of epratuzumab treatment. ;Primary end point(s): Number and percent of patients with BILAG improvement defined as BILAG A’s at study baseline (SL0007 Visit 1) improved to B/C/D and BILAG B’s at study baseline (SL0007 Visit 1) improved to C/D and no BILAG Worsening in other BILAG organ systems such that there are no new BILAG A’s or two new BILAG B’s as compared to Visit 1 of SL0007. | — |
Countries
Belgium, Hungary, Lithuania, Spain, United Kingdom
Outcome results
None listed