Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

NCT01878123 | Completed Phase 1

• 1 other identifier: AMP-110-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo

  Evaluate number of subjects with dose-limiting toxicities (through Day 14), evaluate number of subjects wtih adverse events (through Day 56), and number of subjects wtih changes from baseline in laboratory values, vital signs, physical exam and electrocardiogram (through Day 56)

  From start of study drug administration through Day 56

• Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials

  Based on the occurrence of dose-limiting toxicities (through Day 14)

  From start of study drug administration through Day 56

Secondary Outcomes (1)

• Evaluate pharmacokinetic profile of a single dose of AMP-110

  From Day 0 pre-dose through Day 28

Other Outcomes (2)

• Assess pharmacokinetic and pharmacodynamic relationships

  From Day 0 pre-dose through Day 56

• Evaluate exploratory biomarkers

  From start of study drug administration through Day 56

Study Arms (2)

AMP-110

EXPERIMENTAL

Escalating doses of AMP-110

Biological: AMP-110

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

AMP-110 BIOLOGICAL

Dose levels 1 through 7: Single intravenous infusion on Day 0

AMP-110

Placebo OTHER

Dose levels 4 through 7: Single intravenous infusion on Day 0

Placebo

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
• Stable use of \>/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for \>/= 4 weeks prior to Day 0, including:
• Methotrexate (MTX) 7.5 - 25 mg/week
• Hydroxychloroquine (HCQ) \</= 400 mg/day
• Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
• Leflunomide 5 - 20 mg/day
• Azathioprine 150 mg/day or 2 mg/kg/day
• Combinations of MTX, HCQ, and/or SSZ allowed

You may not qualify if:

• Prior to Day 0, use of
• Abatacept
• Rituximab within 6 months
• Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
• Etanercept or Anakinra within 28 days
• Immunoglobulin or blood products within 28 days
• Evidence of any active or recent infection including ongoing, chronic infectious disease such as chronic renal infection or chronic chest infection with bronchiectasis or sinusitis
• History of systemic autoimmune disease other than Rheumatoid Arthritis
• History of allergic reactions to other protein therapeutics such as monoclonal antibodies or fusion proteins
• 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 wtih live attenuated viruses within the 2 weeks prior to Day 0
• Evidence of infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus 1 or 2, or active infection with hepatitis A
• Pregnant or breastfeeding women

Sponsors & Collaborators

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

Study Sites (3)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, 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; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: June 14, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 30, 2016

Record last verified: 2016-08

Locations

US (3)