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

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ClinicalTrials.gov Identifier: NCT01878123
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
MedImmune LLC

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: AMP-110 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
Study Start Date : April 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AMP-110
Escalating doses of AMP-110
Biological: AMP-110
Dose levels 1 through 7: Single intravenous infusion on Day 0

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




Primary Outcome Measures :
  1. Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo [ Time Frame: From start of study drug administration through Day 56 ]
    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)

  2. Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials [ Time Frame: From start of study drug administration through Day 56 ]
    Based on the occurrence of dose-limiting toxicities (through Day 14)


Secondary Outcome Measures :
  1. Evaluate pharmacokinetic profile of a single dose of AMP-110 [ Time Frame: From Day 0 pre-dose through Day 28 ]
    Pharmacokinetics evaluated by area under the serum concentration versus time curve (AUC), peak serum concentration (Cmax), and clearance (Cl) of AMP-110


Other Outcome Measures:
  1. Assess pharmacokinetic and pharmacodynamic relationships [ Time Frame: From Day 0 pre-dose through Day 56 ]
    Determine if pharmacodynamics effects of AMP-110 on certain cytokine levels and T cell subsets are dependent on serum drug concentrations

  2. Evaluate exploratory biomarkers [ Time Frame: From start of study drug administration through Day 56 ]
    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



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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:

  • 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:

    1. Methotrexate (MTX) 7.5 - 25 mg/week
    2. Hydroxychloroquine (HCQ) </= 400 mg/day
    3. Sulfasalazine (SSZ) 1,000 - 3,000 mg/day
    4. Leflunomide 5 - 20 mg/day
    5. Azathioprine 150 mg/day or 2 mg/kg/day
    6. Combinations of MTX, HCQ, and/or SSZ allowed

Exclusion Criteria:

  • Prior to Day 0, use of

    1. Abatacept
    2. Rituximab within 6 months
    3. Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months
    4. Etanercept or Anakinra within 28 days
    5. 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

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): NCT01878123


Locations
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United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Sponsors and Collaborators
MedImmune LLC
Daiichi Sankyo Co., Ltd.

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01878123     History of Changes
Other Study ID Numbers: AMP-110-01
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: August 2016

Keywords provided by MedImmune LLC:
Arthritis
Rheumatoid Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic agents

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