Safety Study of AMG 557 in Subjects With Lupus Arthritis

Amgen

Status and phase: Completed; Phase 1

Conditions: Lupus Arthritis, Systemic Lupus Erythematosus

Treatments: Drug: Matching Placebo; Drug: AMG 557

Study type: Interventional

Funder types: Industry

Identifiers

NCT01683695

20101103

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
• Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;
• Other inclusion criteria may apply.

Exclusion criteria

• Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
• Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
• Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
• Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
• Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
• Other exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

AMG 557

Active Comparator group

Description:

All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.

Treatment:

Drug: AMG 557

AMG 557 Matching Placebo

Placebo Comparator group

Description:

All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.

Treatment:

Drug: Matching Placebo