Clinical trial NCT01878123: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Arthritis
Rheumatoid Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic agents
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Co., Ltd.
First posted: 2013-06-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Evaluate the safety and tolerability of a single dose of AMP-110 versus placebo
timeFrame: From start of study drug administration through Day 56
measure: Determine Maximum Tolerated Dose and/or recommended dose level(s) for future clinical trials
timeFrame: From start of study drug administration through Day 56
Secondary outcomes:
measure: Evaluate pharmacokinetic profile of a single dose of AMP-110
timeFrame: From Day 0 pre-dose through Day 28
Other outcomes:
measure: Assess pharmacokinetic and pharmacodynamic relationships
timeFrame: From Day 0 pre-dose through Day 56
measure: Evaluate exploratory biomarkers
timeFrame: From start of study drug administration through Day 56
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
Study officials:
References: