Back to resultsStudy to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMP-110
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthritis, Rheumatoid Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases, Antirheumatic agents
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Sites / Locations
- Pinnacle Research Group, LLC
- Altoona Center for Clinical Research
- Metroplex Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMP-110
Placebo
Arm Description
Escalating doses of AMP-110
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Evaluate pharmacokinetic profile of a single dose of AMP-110
Pharmacokinetics evaluated by area under the serum concentration versus time curve (AUC), peak serum concentration (Cmax), and clearance (Cl) of AMP-110
Full Information
NCT ID
NCT01878123
First Posted
May 22, 2013
Last Updated
September 29, 2016
Sponsor
MedImmune LLC
Collaborators
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01878123
Brief Title
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
Official Title
A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
Collaborators
Daiichi Sankyo Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Arthritis, Rheumatoid Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases, Antirheumatic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMP-110
Arm Type
Experimental
Arm Description
Escalating doses of AMP-110
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
AMP-110
Intervention Description
Dose levels 1 through 7: Single intravenous infusion on Day 0
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Dose levels 4 through 7: Single intravenous infusion on Day 0
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo
Description
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)
Time Frame
From start of study drug administration through Day 56
Title
Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials
Description
Based on the occurrence of dose-limiting toxicities (through Day 14)
Time Frame
From start of study drug administration through Day 56
Secondary Outcome Measure Information:
Title
Evaluate pharmacokinetic profile of a single dose of AMP-110
Description
Pharmacokinetics evaluated by area under the serum concentration versus time curve (AUC), peak serum concentration (Cmax), and clearance (Cl) of AMP-110
Time Frame
From Day 0 pre-dose through Day 28
Other Pre-specified Outcome Measures:
Title
Assess pharmacokinetic and pharmacodynamic relationships
Description
Determine if pharmacodynamics effects of AMP-110 on certain cytokine levels and T cell subsets are dependent on serum drug concentrations
Time Frame
From Day 0 pre-dose through Day 56
Title
Evaluate exploratory biomarkers
Description
Blood samples will be analyzed throughout the study to characterize the physiological effects of AMP-110 treatment and to determine markers that correlate with response to treatment
Time Frame
From start of study drug administration through Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
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