Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03156023
• Collaborator: (none)
• Enrollment: 34
• Locations: 4
• Arms: 2
• Actual Duration (Months): 33.9
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.3

Study Details

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
• 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: Aug 14, 2017
• Actual Primary Completion Date: Oct 17, 2019
• Actual Study Completion Date: Jun 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 [34 weeks]

2. Number of participants with clinically significant changes in physical examinations [34 weeks]

3. Number of participants with clinically significant changes in vital signs [34 weeks]

4. Number of participants with clinically significant changes in laboratory safety tests [34 weeks]

5. Number of participants with clinically significant changes in electrocardiograms (ECGs) [34 weeks]

Secondary Outcome Measures

1. Serum PK parameter of maximum-observed concentration (Cmax) [34 weeks]

2. Serum PK parameter of time at Cmax [tmax] [34 weeks]

3. Serum PK parameter of area under the curve (AUC) [34 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group LLC	Anniston	Alabama	United States	36207
2	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
3	Metroplex Clinical Research Center	Dallas	Texas	United States	75231
4	Charite Research Organisation GmbH	Berlin		Germany	10117

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT03156023
• Other Study ID Numbers: 20150196
• First Posted: May 16, 2017
• Last Update Posted: Oct 11, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

No Results Posted as of Oct 11, 2021