The main purpose of this study was to evaluate the safety and pharmacokinetics (PK, the action of a drug in the body over a period of time) of multiple intravenous (IV) administrations of CNTO 136 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). The secondary goal of this study was to assess the pharmacodynamics (biochemical and physiological effects of a drug and the mechanisms of action), immune response, and clinical response.
In Part A of this study, patients with CLE were randomly assigned (like flipping a coin) to receive multiple IV doses of CNTO 136, a human anti-IL 6 monoclonal antibody (an immune protein that binds to interleukin 6) or placebo (a substance that appears identical to the treatment and has no active ingredients). Patients and study personnel did not know the identity of the administered treatments (double-blind study). Increasing doses were given, based on safety data collected during the initial weeks of treatment. In Part B, which was also double-blind, patients with SLE were randomly assigned to receive multiple IV doses of the highest well-tolerated dose, as determined in Part A, of CNTO 136, or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
Type=exact number, unit=mg, number=1, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Type=exact number, unit=mg, number=4, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Form=liquid for infusion, route=intravenous use, every 2 weeks for 6 weeks.
Number of participants with adverse events
Time frame: Up to 26 weeks
Pharmacokinetic profile of CNTO 136
Blood serum concentration over time
Time frame: Up to 22 weeks
Physical examinations
Assessment of head, eyes, ears, nose and throat, skin and neck, lungs, heart, abdomen, extremities, general neurologic status, and oral examination
Time frame: Up to 26 weeks
Electrocardiograms (ECGs)
Time frame: Up to 26 weeks
Sitting blood pressure
Time frame: Up to 26 weeks
Heart rate
Time frame: Up to 26 weeks
Respiration rate
Time frame: Up to 26 weeks
Oral temperature
Time frame: Up to 26 weeks
Hemoglobin
Time frame: Up to 26 weeks
Hematocrit
Time frame: Up to 26 weeks
Platelets and total white blood cells (WBC)
Time frame: Up to 26 weeks
Albumin and total protein
Time frame: Up to 26 weeks
Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST)
Time frame: Up to 26 weeks
Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin
Time frame: Up to 26 weeks
Chloride, potassium, and sodium
Time frame: Up to 26 weeks
Bicarbonate
Time frame: Up to 26 weeks
Creatine kinase
Time frame: Up to 26 weeks
Gamma-glutamyl-transferase
Time frame: Up to 26 weeks
Glucose
Time frame: Up to 26 weeks
Lymphocytes and neutrophils
Time frame: Up to 26 weeks
Inorganic phosphate
Time frame: Up to 26 weeks
Fasting Lipid Panel
Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very low-density lipoprotein (VLDL), and triglycerides.
Time frame: Up to 8 weeks
Pharmacodynamics evaluations
Percentage change from baseline in serum and plasma biomarker data
Time frame: Up to 22 weeks
Immune response
The formation of antibodies to CNTO 136
Time frame: Up to 22 weeks
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Measurement of disease activity, scored from 0 (absent) to 70 (severe), and damage, scored from 0 (absent) to 56 (severe)
Time frame: Up to 22 weeks
British Isles Lupus Assessment Group (BILAG) score
Measures the need for alterations or intensification of therapy. The assessing physician considers each item as to its presence in the past month, and answers 0 = not present, 1 = improving; 2 = same; 3 = worse; or 4 = new.
Time frame: Up to 22 weeks
SELENA-SLEDAI Flare Composite
Assesses the presence and severity of lupus flare. Scores range from 0 (mild) to 105 (severe).
Time frame: Up to 22 weeks
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