Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Background NSAID · 1 trial · 1 indication
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
| Arm | Type | Description |
|---|---|---|
| etanercept | ACTIVE_COMPARATOR | In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly SC once weekly. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. |
| PLACEBO | PLACEBO_COMPARATOR | In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. |
| Name | Type | Description |
|---|---|---|
| etanercept | BIOLOGICAL | In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. |
| Background NSAID | DRUG | Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician. |
| PLACEBO | OTHER | In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician. |
Inclusion Criteria: * Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria * Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) \> or = 4 * Axial symptoms of back pain with a less than favorable response to on steroida...
Background NSAID is a small molecule being studied for use in Ankylosing Spondylitis, specifically in patients with early spondyloarthritis who do not have X-ray structural changes. It is intended to be used alongside other treatments, as part of a combination approach in this patient population.
Background NSAID is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical research to evaluate this small molecule in the treatment of Ankylosing Spondylitis.
Background NSAID is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform whether further development or regulatory submission occurs.
Background NSAID has been studied in one completed Phase 3 clinical trial, identified as NCT01258738. This randomized, double-blind, placebo-controlled study enrolled 225 participants with Ankylosing Spondylitis across multiple countries, including Argentina, Belgium, Colombia, Czechia, Finland, France, Germany, Hungary, Netherlands, Russia, South Korea, Spain, Taiwan, and the United Kingdom.
No, Background NSAID is not the same as Etanercept. In the clinical trial NCT01258738, Background NSAID refers to the nonsteroidal anti-inflammatory drug (NSAID) that patients were already taking, while Etanercept was the investigational treatment being compared against placebo on top of that background NSAID therapy.