Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus
Phase 1
- Conditions
- Active Systemic Lupus ErythematosusMedDRA version: 18.0Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-002184-14-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Male or female aged between 18 to 70 (included)
Diagnosed with active systemic lupus erythomatosus by a doctor
Disease must be in patient’s joints or on the skin at a minimum
Taking other medications is allowed but some are excluded
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
Exclusion Criteria
Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
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