Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis

Completed · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).

Key facts

Study ID

NCT03156023

Run by

Amgen

People needed

34

Starts

2017-08-14

Expected to finish

2020-06-12

Last updated by the study team

2024-05-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body Mass Index: 18-35 kg/m\^2
• Diagnosed with RA (disease duration of at least 6 months)
• Stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks)
• Immunizations up to date
• Willing to use highly effective contraception during treatment and through end-of-study

You may not qualify if…

• 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 according to American College of Rheumatology/ (ACR) revised response criteria
• 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

Where it is running

• Pinnacle Research Group LLC — Anniston, Alabama, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Charite Research Organisation GmbH — Berlin, Germany

Full record on ClinicalTrials.gov

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