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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
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This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover Group 1 | Experimental | 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 |
|
| Crossover Group 2 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMP-110 | Biological | 2, 5, or 10 mg/kg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo | Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations | From start of study drug administration through Day 112 |
| Repeat dose pharmacokinetic parameters of AMP-110 in serum | Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life | From start of study drug administration through Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal dose for repeat dosing of AMP-110 | 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 | From start of study drug administration through Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical responses via RA disease scoring systems | Explore the pharmacodynamics (PD) of repeat doses of AMP-110 versus placebo in subjects with RA | From start of study drug administration through Day 112 |
Inclusion Criteria:
Exclusion Criteria:
Prior to Day 0, use of:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Omega Research Consultants, LLC. |
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| Other |
Placebo |
|
| Orlando |
| Florida |
| 32804 |
| United States |
| Arthritis Center, Inc. | Palm Harbor | Florida | 34684 | United States |
| Arthritis Treatment Center | Frederick | Maryland | 21702 | United States |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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