Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis

NCT02277574 | Completed Phase 1

• 1 other identifier: AMP-110-02
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Arthritis; Joint diseases; Musculoskeletal diseases

Outcome Measures

Primary Outcomes (2)

• Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo

  Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations

  From start of study drug administration through Day 112

• Repeat dose pharmacokinetic parameters of AMP-110 in serum

  Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life

  From start of study drug administration through Day 112

Secondary Outcomes (1)

• Optimal dose for repeat dosing of AMP-110

  From start of study drug administration through Day 112

Other Outcomes (1)

• Clinical responses via RA disease scoring systems

  From start of study drug administration through Day 112

Study Arms (2)

Crossover Group 1

EXPERIMENTAL

Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo

Biological: AMP-110

Crossover Group 2

EXPERIMENTAL

Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week

Other: Placebo

Interventions

AMP-110 BIOLOGICAL

2, 5, or 10 mg/kg

Crossover Group 1

Placebo OTHER

Placebo

Crossover Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to provide written informed consent
• Body mass index 18.5 to 35.0 kg/m2
• Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
• Global Functional Class I, II, or III according to ACR 1991 revised criteria
• Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)
• Use of \>/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for \>/= 2 weeks prior to randomization
• Use of \>/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for \>/= 3 months and a stable dose for \>/= 6 weeks prior to randomization
• Stable use of low dose oral corticosteroids (\</= 10 mg prednisone per day or equivalent) is allowed; subjects must be on a stable dose for \>/= 4 weeks prior to randomization

You may not qualify if:

• Prior to Day 0, use of:
• Rituximab within 6 months
• Abatacept within 3 months
• Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
• Etanercept, Anakinra, immunoglobulin or blood products within 28 days
• Prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, Janus kinase (JAK) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer
• Prior exposure to T cell depleting agents such as Campath (alemtuzumab)
• Evidence of any active or recent infection
• History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed
• History of allergic reactions
• History of anaphylaxis or allergic diathesis
• Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
• Evidence of active or latent tuberculosis
• Vaccination with live attenuated viruses within the 2 weeks prior to Day 0
• Pregnant or breastfeeding women

Sponsors & Collaborators

• MedImmune LLC: lead
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (7)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Omega Research Consultants, LLC.

Orlando, Florida, 32804, United States

Location

Arthritis Center, Inc.

Palm Harbor, Florida, 34684, United States

Location

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: October 29, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

US (7)