Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)
- Conditions
- Systemic Lupus Erythematosus (SLE)MedDRA version: 17.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2013-002773-21-DE
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 279
- Male or female of =18 years of age, who provide written informed consent at screening
- SLEDAI-2K score =6 at screening
- Diagnosis of SLE satisfying at least 4 out of the 11 ACR classification criteria for SLE during the course of their illness at screening
- Disease duration of at least 6 months from the time of diagnosis (when the subject met at least 4 of the ACR criteria) at screening
- Positive test results for ANA (human epithelial cell [Hep]-2 ANA = or >1:80) and/or anti-dsDNA antibody (=30 IU/mL) at screening
- Other protocol defined inclusion criteria may apply
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 265
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
- History or current diagnosis of any demyelinating disease
- Active central nervous system SLE deemed to be severe or progressive
- Use of cyclophosphamide within 3 months before or during SV
- Active, moderate to severe glomerulonephritis and/or severe renal impairment (spot urine protein:creatinine ratio [UPCr] =2 mg/mg
-Other protocol defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method