Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, Arthritis, Joint diseases, Musculoskeletal diseases
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.
Interventions
BIOLOGICALAMP-110
2, 5, or 10 mg/kg
OTHERPlacebo
Placebo
Sponsors
Daiichi Sankyo Co., Ltd.
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo | 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 |
| Repeat dose pharmacokinetic parameters of AMP-110 in serum | 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
| Measure | Time frame | Description |
|---|---|---|
| Optimal dose for repeat dosing of AMP-110 | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical responses via RA disease scoring systems | 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 |
Countries
United States
Outcome results
None listed