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

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 - SELECT-PsA 1

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55411

Enrollment

Registered

2017-07-11

Start date

2018-08-01

Completion date

Unknown

Last updated

2024-06-24

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

Each study participant will need to take study drug by mouth once daily (upadacitinib low dose or high dose, or matching placebo tablets) and injections under the skin every 2 weeks (adalimumab or m

Eligibility

Age

18 Years to 99 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 is on current treatment with = 1 erosion on x-ray • hs-CRP > laboratory-defined upper limit of normal (ULN)

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 modified PsA Sharp/van der Heijde Score (SHS) 5. Proportion of subjects achieving Minimal Disease Activity (MDA) 6. Change from baseline in Leeds Enthesitis Index (LEI) 7. Change from baseline in Leeds Dactylitis Index (LDI) 8. ACR 20 response rate (non-inferiority of upadacitinib vs adalimumab); 9. Change from baseline in SF-36 PCS 10. ACR 20 response rate (superiority of upadacitinib vs adalimumab); 11. Change from baseline in Patient's Assessment of Pain NRS (superiority of upadacitinib vs. adalimumab); 12. Change from baseline in HAQ-DI (superiority of upadacitinib vs. adalimumab); 13. Change from baseline in FACIT-Fatigue Questionnaire; 14.Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 15. ACR 50/70 response rate 16. 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 modified PsA Sharp/van der Heijde Score (SHS) 5. Proportion of subjects achieving Minimal Disease Activity (MDA) 6. Change from baseline in Leeds Enthesitis Index (LEI) 7. Change from baseline in Leeds Dactylitis Index (LDI) 8. ACR 20 response rate (non-inferiority of upadacitinib vs adalimumab); 9. Change from baseline in SF-36 PCS 10. ACR 20 response rate (superiority of upadacitinib vs adalimumab); 11. Change from baseline in Patient's Assessment of Pain NRS (superiority of upadacitinib vs. adalimumab); 12. Change from baseline in HAQ-DI (superiority of upadacitinib vs. adalimumab); 13. Change from baseline in FACIT-Fatigue Questionnaire; 14.Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 15. ACR 50/70 response rate 16. ACR 20 response rate at Week 1

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)