Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Single-Dose, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis
Verified date | August 2016 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pinnacle Research Group, LLC | Anniston | Alabama |
United States | Metroplex Clinical Research Center | Dallas | Texas |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC | Daiichi Sankyo Co., Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assess pharmacokinetic and pharmacodynamic relationships | Determine if pharmacodynamics effects of AMP-110 on certain cytokine levels and T cell subsets are dependent on serum drug concentrations | From Day 0 pre-dose through Day 56 | No |
Other | Evaluate exploratory biomarkers | 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 | From start of study drug administration through Day 56 | No |
Primary | 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) | From start of study drug administration through Day 56 | Yes |
Primary | 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) | From start of study drug administration through Day 56 | Yes |
Secondary | 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 | From Day 0 pre-dose through Day 28 | No |
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