Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus Erythematosus
Brief Summary: 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.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: MEDI 545 | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: MEDI-545 | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Biological: MEDI-545 | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Biological: MEDI-545 | Arm Label: 5; Type: ACTIVE_COMPARATOR; Interventions: Biological: MEDI-545 | Intervention Type: BIOLOGICAL; Name: MEDI-545; Assigned to Arm(s): 2 | Intervention Type: BIOLOGICAL; Name: MEDI 545; Assigned to Arm(s): 1 | Intervention Type: BIOLOGICAL; Name: MEDI-545; Assigned to Arm(s): 3 | Intervention Type: BIOLOGICAL; Name: MEDI-545; Assigned to Arm(s): 4 | Intervention Type: BIOLOGICAL; Name: MEDI-545; Assigned to Arm(s): 5
B: Arm Label: A-623 high dose weekly; Type: EXPERIMENTAL; Interventions: Drug: A-623 | Arm Label: A-623 low dose weekly; Type: EXPERIMENTAL; Interventions: Drug: A-623 | Arm Label: A-623 high dose every 4 weeks; Type: EXPERIMENTAL; Interventions: Drug: A-623 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo Comparator | Intervention Type: DRUG; Name: A-623; Assigned to Arm(s): A-623 high dose weekly | Intervention Type: DRUG; Name: A-623; Assigned to Arm(s): A-623 low dose weekly | Intervention Type: DRUG; Name: A-623; Assigned to Arm(s): A-623 high dose every 4 weeks | Intervention Type: OTHER; Name: Placebo Comparator; Assigned to Arm(s): Placebo
C: Arm Label: Part A, 1 mg/kg CNTO 136; Type: EXPERIMENTAL; Interventions: Drug: 1 mg/kg CNTO 136 | Arm Label: Part A, 4 mg/kg CNTO 136; Type: EXPERIMENTAL; Interventions: Drug: 4 mg/kg CNTO 136 | Arm Label: Part A, 10 mg/kg CNTO 136; Type: EXPERIMENTAL; Interventions: Drug: 10 mg/kg CNTO 136 | Arm Label: Part B, 10 mg/kg CNTO 136/placebo; Type: EXPERIMENTAL; Interventions: Drug: 10 mg/kg CNTO 136, Drug: Placebo | Intervention Type: DRUG; Name: 1 mg/kg CNTO 136; Assigned to Arm(s): Part A, 1 mg/kg CNTO 136 | Intervention Type: DRUG; Name: 4 mg/kg CNTO 136; Assigned to Arm(s): Part A, 4 mg/kg CNTO 136 | Intervention Type: DRUG; Name: 10 mg/kg CNTO 136; Assigned to Arm(s): Part A, 10 mg/kg CNTO 136, Part B, 10 mg/kg CNTO 136/placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part B, 10 mg/kg CNTO 136/placebo
D: Arm Label: HCQ; Type: ACTIVE_COMPARATOR; Interventions: Drug: hydroxychloroquine (Z0188) | Arm Label: Placebo; Type: OTHER; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: hydroxychloroquine (Z0188); Assigned to Arm(s): HCQ | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C