Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis

Status:	Active, not recruiting
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - 75
Updated:	3/9/2019
Start Date:	August 14, 2017
End Date:	October 18, 2019

A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis

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.

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

We found this trial at

sites

Clinical Trial Facility in Berlin

Berlin, 10707

from

Berlin,