EUCTR2017-001944-36-ES
Active, not recruiting
Phase 1
A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Amgen Inc
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Subject has provided informed consent prior to initiation of any study specific
- •activities/procedures.
- •\- Age \= 18 to \= 70 years of age at screening
- •\- A diagnosis of RA consistent with the 1987 or 2010 American College of
- •Rheumatology (ACR)/European League Against Rheumatism classification
- •\- Active RA defined as:
- •Phase 1b: DAS\-28\-CRP \> 2\.6 at screening. The 28\-joint count consists of
- •the finger joints excluding the distal interphalangeal joints, the wrists, elbows,
- •shoulders, and knees.
- •Phase 2a: \= 6 swollen joints (based on 66\-joint count) and \= 6 tender joints
Exclusion Criteria
- •Disease Related:
- •\- Class IV RA according to ACR revised response criteria
- •\- Diagnosis of Felty’s Syndrome (RA, splenomegaly and granulocytopenia)
- •Other Medical Conditions
- •\- Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.
- •\- Active infection (including chronic or localized infections) for which anti\-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti\-infectives within 8 weeks prior to day 1\.
- •\- Known history of active tuberculosis
- •\- Positive test for tuberculosis during screening
- •\- Positive for hepatitis B surface antigen, hepatitis B core antibody .
- •\- Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or
Outcomes
Primary Outcomes
Not specified
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