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Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03156023
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

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

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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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156023


Locations
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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
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03156023    
Other Study ID Numbers: 20150196
First Posted: May 16, 2017    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases