A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) - SELECT - PsA 2

A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) - SELECT - PsA 2 - SELECT-PsA 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45660

Enrollment

Registered

2018-01-15

Start date

2018-07-17

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artritis Psoriatica psoriatic arthritis

Interventions

Placebo

Psoriatic Artritis

Each study participant will need to take study drug by mouth once daily (upadacitinib low or high dose, or matching placebo tablets)

Double Blind

JAK-inhibitor

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, at least 18 years of age 2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) 3. Subject has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits 4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis 5. Subject has had an inadequate response or an intolerance to treatment with at least 1 bDMARD

Exclusion criteria

Exclusion criteria: 1. Prior exposure to any Janus Kinase (JAK) inhibitor 2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects achieving ACR20 response	—

Secondary

Measure	Time frame
1. Change from baseline in HAQ-DI 2. Proportion of subjects achieving a static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline 3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with >= 3% BSA psoriasis at baseline) 4. Change from baseline in SF-36 PCS 5. Proportion of subjects achieving Minimal Disease Activity (MDA) 6. Change from baseline in FACIT-Fatigue Questionnaire; 7. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 8. ACR 50/70 response rate 9. ACR 20 response rate at Week 1	—

Measure

Time frame

1. Change from baseline in HAQ-DI 2. Proportion of subjects achieving a static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline 3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with >= 3% BSA psoriasis at baseline) 4. Change from baseline in SF-36 PCS 5. Proportion of subjects achieving Minimal Disease Activity (MDA) 6. Change from baseline in FACIT-Fatigue Questionnaire; 7. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 8. ACR 50/70 response rate 9. ACR 20 response rate at Week 1

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea (the Democratic Peoples Republic of), Korea (the Republic of), Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan (Province of China), Thailand, Turkey, Ukraine, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)