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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Other: Placebo; Biological: AMP-110

Study type: Interventional

Funder types: Industry

Identifiers

NCT01878123

AMP-110-01

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

AMP-110

Experimental group

Description:

Escalating doses of AMP-110

Treatment:

Biological: AMP-110

Placebo

Placebo Comparator group

Treatment:

Other: Placebo