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.
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
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