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

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ClinicalTrials.gov Identifier: NCT02277574
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : November 21, 2016
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
MedImmune LLC

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.

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 : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crossover Group 1
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
2, 5, or 10 mg/kg

Experimental: Crossover Group 2
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
Placebo




Primary Outcome Measures :
  1. Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo [ Time Frame: From start of study drug administration through Day 112 ]
    Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations

  2. Repeat dose pharmacokinetic parameters of AMP-110 in serum [ Time Frame: From start of study drug administration through Day 112 ]
    Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life


Secondary Outcome Measures :
  1. Optimal dose for repeat dosing of AMP-110 [ Time Frame: From start of study drug administration through Day 112 ]
    Optimal dose will be determined through the occurrence of AEs, SAEs, ACR-20 and DAS-28 results, and individual AMP-110 concentrations in serum including peak and trough levels


Other Outcome Measures:
  1. Clinical responses via RA disease scoring systems [ Time Frame: From start of study drug administration through Day 112 ]
    Explore the pharmacodynamics (PD) of repeat doses of AMP-110 versus placebo in subjects with RA



Information from the National Library of Medicine

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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
  • 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

Exclusion Criteria:

  • Prior to Day 0, use of:

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

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): NCT02277574


Locations
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United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
United States, Florida
Omega Research Consultants, LLC.
Orlando, Florida, United States, 32804
Arthritis Center, Inc.
Palm Harbor, Florida, United States, 34684
United States, Maryland
Arthritis Treatment Center
Frederick, Maryland, United States, 21702
United States, Nebraska
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States, 68516
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: NCT02277574     History of Changes
Other Study ID Numbers: AMP-110-02
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016

Keywords provided by MedImmune LLC:
Rheumatoid arthritis
Arthritis
Joint diseases
Musculoskeletal diseases

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