Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT03156023
• Recruitment Status: Completed
• First Posted: May 16, 2017
• Last Update Posted: July 7, 2020
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: AMG 570; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 14, 2017
• Actual Primary Completion Date: October 17, 2019
• Actual Study Completion Date: June 12, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active; Receive active investigational product (AMG 570).	Drug: AMG 570; Investigational product solution in vial
Placebo Comparator: Placebo; Receive placebo investigational product	Drug: Placebo; Placebo investigational product in vial

Outcome Measures

Primary Outcome Measures :

1. Number of participants with treatment-emergent adverse events [ Time Frame: 34 weeks ]
2. Number of participants with clinically significant changes in physical examinations [ Time Frame: 34 weeks ]
3. Number of participants with clinically significant changes in vital signs [ Time Frame: 34 weeks ]
4. Number of participants with clinically significant changes in laboratory safety tests [ Time Frame: 34 weeks ]
5. Number of participants with clinically significant changes in electrocardiograms (ECGs) [ Time Frame: 34 weeks ]

Secondary Outcome Measures :

1. Serum PK parameter of maximum-observed concentration (Cmax) [ Time Frame: 34 weeks ]
2. Serum PK parameter of time at Cmax [tmax] [ Time Frame: 34 weeks ]
3. Serum PK parameter of area under the curve (AUC) [ Time Frame: 34 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Research Site

Anniston, Alabama, United States, 36207

United States, Pennsylvania

Research Site

Duncansville, Pennsylvania, United States, 16635

United States, Texas

Research Site

Dallas, Texas, United States, 75231

Germany

Research Site

Berlin, Germany, 10117

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT03156023
• Other Study ID Numbers: 20150196
• First Posted: May 16, 2017
• Last Update Posted: July 7, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• URL: https://www.amgen.com/datasharing

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases