Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2020-06-12
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the safety and tolerability of AMG 570 following multiple dose administration in subjects with rheumatoid arthritis (RA).

A study to characterize the pharmacokinetic profile of AMG 570 following multiple dose administration in subjects with RA.

Hypothesis: Multiple dose administration of AMG 570 will have acceptable safety and tolerability profiles in RA subjects within the proposed dose range.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Body Mass Index: 18-35 kg/m2

• Diagnosed with RA (disease duration of at least 6 months)

• Stable dose of methotrexate (5-25 mg weekly)

• Immunizations up to date

• Willing to use highly effective contraception during treatment and through end-of-study

Exclusion Criteria:

• Uncontrolled, clinically significant systemic disease other than RA (i.e., diabetes mellitus, liver disease, asthma, cardiovascular disease, hypertension)

• Malignancy within 5 years

• Presence of serious infection, recurrent/chronic infections

• Class IV RA

• Diagnosed with Felty's syndrome

• Known or suspected sensitivity to mammalian cell-derived products

• History of alcohol and/or substance abuse within the last 12 months

• Receipt of rituximab at any time in the past

• Evidence of renal disease