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Janus Kinase (JAK) Inhibitor

Upadacitinib for Psoriatic Arthritis (SELECT - PsA 2 Trial)

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant 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
Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
Must not have
Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Pivotal Trial

Summary

This trial is comparing the efficacy, safety, and tolerability of two doses of upadacitinib (15 mg and 30 mg) to placebo for the treatment of psoriatic arthritis. The trial will consist of two periods: Period 1 will compare the three groups of participants and Period 2 will evaluate the long-term safety, tolerability and efficacy of the two doses of upadacitinib.

Who is the study for?
This trial is for adults with moderately to severely active psoriatic arthritis who didn't respond well or couldn't tolerate at least one biologic DMARD. They must have at least 3 tender and swollen joints, a diagnosis of PsA for over 6 months, and meet specific criteria. People taking more than two non-biologic DMARDs or any JAK inhibitors can't join.
What is being tested?
The study tests the effectiveness of Upadacitinib (15 mg or 30 mg daily) compared to a placebo in improving symptoms of psoriatic arthritis. The first period assesses short-term effects while the second looks at long-term safety and benefits for those who finish the first phase.
What are the potential side effects?
Upadacitinib may cause side effects such as infections, liver issues, blood clots, cholesterol changes, gastrointestinal problems, and allergic reactions. Long-term use will be monitored for additional side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least 3 tender and 3 swollen joints.
Select...
I have been diagnosed with Psoriatic Arthritis for at least 6 months.
Select...
I have been diagnosed with plaque psoriasis.
Select...
I tried a biologic drug for over 12 weeks without improvement or couldn't tolerate it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never taken JAK inhibitor medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Secondary study objectives
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
+7 more

Side effects data

From 2024 Phase 3 trial • 642 Patients • NCT03104374
6%
UPPER RESPIRATORY TRACT INFECTION
5%
BRONCHITIS
5%
NASOPHARYNGITIS
4%
URINARY TRACT INFECTION
4%
INFLUENZA
4%
PSORIATIC ARTHROPATHY
2%
BLOOD CREATINE PHOSPHOKINASE INCREASED
2%
SINUSITIS
2%
DIARRHOEA
2%
NAUSEA
2%
HYPERTENSION
1%
NEPHROLITHIASIS
1%
HERPES ZOSTER
1%
ALANINE AMINOTRANSFERASE INCREASED
100%
80%
60%
40%
20%
0%
Study treatment Arm
Upadacitinib 15 mg: Week 1-24
Upadacitinib 30 mg: Week 1-56
Upadacitinib 30 mg: Week 1-24
Placebo: Week 1-24
Upadacitinib 15 mg: Week 1-56

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ABT-494 Dose BExperimental Treatment1 Intervention
It is administered once daily.
Group II: ABT-494 Dose AExperimental Treatment1 Intervention
It is administered once daily.
Group III: Placebo followed by ABT-494 Dose BPlacebo Group2 Interventions
It is administered once daily.
Group IV: Placebo followed by ABT-494 Dose APlacebo Group2 Interventions
It is administered once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABT-494
2017
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,040 Previous Clinical Trials
522,937 Total Patients Enrolled
22 Trials studying Psoriatic Arthritis
108,263 Patients Enrolled for Psoriatic Arthritis
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
163,722 Total Patients Enrolled
7 Trials studying Psoriatic Arthritis
9,670 Patients Enrolled for Psoriatic Arthritis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,977 Total Patients Enrolled
11 Trials studying Psoriatic Arthritis
13,428 Patients Enrolled for Psoriatic Arthritis

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03104374 — Phase 3
Psoriatic Arthritis Research Study Groups: ABT-494 Dose A, Placebo followed by ABT-494 Dose B, ABT-494 Dose B, Placebo followed by ABT-494 Dose A
Psoriatic Arthritis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT03104374 — Phase 3
Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03104374 — Phase 3
~75 spots leftby Dec 2025
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