Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)
Summary
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Conditions
Immune System Diseases
Intervention
CDP7657, Placebo
Location
Berlin
Germany
Status
Recruiting
Source
UCB, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01093911
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:14:58-0400
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Medical and Biotech [MESH] Definitions
Immune Complex Diseases
Group of diseases mediated by the deposition of large soluble complexes of antigen and antibody with resultant damage to tissue. Besides SERUM SICKNESS and the ARTHUS REACTION, evidence supports a pathogenic role for immune complexes in many other IMMUNE SYSTEM DISEASES including GLOMERULONEPHRITIS, systemic lupus erythematosus (LUPUS ERYTHEMATOSUS, SYSTEMIC) and POLYARTERITIS NODOSA.
Autoimmune Diseases Of The Nervous System
Disorders caused by cellular or humoral immune responses primarily directed towards nervous system autoantigens. The immune response may be directed towards specific tissue components (e.g., myelin) and may be limited to the central nervous system (e.g., MULTIPLE SCLEROSIS) or the peripheral nervous system (e.g., GUILLAIN-BARRE SYNDROME).
Neuroimmunomodulation
The biochemical and electrophysiological interactions between the NERVOUS SYSTEM and IMMUNE SYSTEM that result in regulation of the immune system by the nervous system.
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The theory that infectious agents, symbiotic microorganisms, and parasites are normal stimulants for the maturation of the immune system toward a balanced immune response. The theory predicts that lack of such stimulation leads to allergies and AUTOIMMUNE DISEASES.
Immunomodulation
Alteration of the immune system or of an immune response by agents that activate or suppress its function. This can include IMMUNIZATION or administration of immunomodulatory drugs. Immunomodulation can also encompass non-therapeutic alteration of the immune system effected by endogenous or exogenous substances.
