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Abbvie Psoriatic Arthritis Comparative Study


Title A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) – SELECT – PsA 1
Therapeutic Area Psoriatic Arthritis
Principal Investigator Steven C. Vlad, MD, PhD
Min Age 18 Years
Gender Any
Contact Vivian Deng
617-636-5727
More Information https://www.clinicaltrials.gov/ct2/show/NCT03104400

Overview

This study evaluates the safety and efficacy of the study drug ABT-494 as compared to a current FDA-approved drug, adalimumab, as well as a placebo. ABT-494 aims to inhibit the JAK1, which is partially responsible for inflammation associated with psoriatic arthritis. Although ABT-494 is not FDA approved, it has seen success in the first 2 phases of trials.

Study Details

Inclusion Criteria

  • Subject must have clinical diagnosis of psoriatic arthritis
  • Subject must have a history of inadequate response to at least one non-biologic disease modifying anti-rheumatic drug (DMARD)
  • Subject must have a stable use of NSAIDs

Exclusion Criteria

  • Subject with current diagnosis of other inflammatory joint disease
  • Subject who has a current treatment with more than 2 non-biologic DMARDs
  • Subject who are breastfeeding or pregnant 

Study Requirements

The Abbvie study will require a total of 21 visits over 140 weeks, including a maximum of five x-rays of the hands and feet. The first visit will require a chest X-ray along with urine and blood tests; all subsequent visits will require urine and blood collection. The study requires an injection of active medication or placebo every other week as well as daily oral intake of active medication or placebo. There is a 50% chance of receiving the active medication ABT-494 in varying doses, 25% chance of receiving adalimumab and 25% chance of receiving a placebo. Subjects have the option to provide additional blood samples for exploratory research and validation studies.