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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

SELECT - PsA 2 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.Check my eligibility

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.See study design

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.

SELECT - PsA 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

SELECT - PsA 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

Secondary outcome measures

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 2023 Phase 3 trial • 613 Patients • NCT03086343

URINARY TRACT INFECTION

UPPER RESPIRATORY TRACT INFECTION

NASOPHARYNGITIS

HYPERTENSION

100%

80%

60%

40%

20%

Study treatment Arm

Abatacept

Upadacitinib 15 mg

SELECT - PsA 2 Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Upadacitinib 30 mgExperimental Treatment1 Intervention

Period 1: Participants receive upadacitinib 30 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Group II: Upadacitinib 15 mgExperimental Treatment1 Intervention

Period 1: Participants receive upadacitinib 15 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Group III: Placebo then Upadacitinib 30 mgPlacebo Group2 Interventions

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Group IV: Placebo then Upadacitinib 15 mgPlacebo Group2 Interventions

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

962 Previous Clinical Trials

502,529 Total Patients Enrolled

22 Trials studying Psoriatic Arthritis

108,263 Patients Enrolled for Psoriatic Arthritis

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

100,915 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: Upadacitinib 15 mg, Upadacitinib 30 mg, Placebo then Upadacitinib 30 mg, Placebo then Upadacitinib 15 mg

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people who meet the requirements will be able to join this trial?

"Although this particular study is not admitting patients at the moment, there are 427 other trials for psoriatic arthritis and 21 trials for Upadacitinib that currently need participants."

Answered by AI

Upadacitinib has been studied before, correct?

"The original clinical trial for upadacitinib was completed in 2015 by C.V. Mehta MD, Med Corporation /ID# 143116. Since then, there have been 18286 similar studies conducted with 21 more underway as of now. Many of these ongoing trials are based out of Skokie, Illinois."

Answered by AI

Are there several sites running this clinical trial in different provinces across Canada?

"There are 77 running for this study, Clinical Investigation Specialists - Skokie /ID# 160068 in Skokie, Shanahan Rheuma & Immuno /ID# 160012 in Raleigh, and Clinical Pharma Study Group /ID# 158712 in Worcester."

Answered by AI

For which conditions is Upadacitinib commonly prescribed?

"Upadacitinib is given to patients that may require systemic therapy. It has also been shown to help those suffering from rheumatoid arthritis, methotrexate, and other conditions where conventional treatments have failed."

Answered by AI

What is the unique selling proposition of this clinical trial?

"AbbVie first sponsored a clinical trial for Upadacitinib in 2015. After the successful completion of that initial study, which had 1629 participants, Upadacitinib entered Phase 3 drug approval. Currently, there are 21 active trials taking place across 953 cities and 54 countries."

Answered by AI

Recent research and studies

Annals of the Rheumatic DiseasesJournal

Upadacitinib for Psoriatic Arthritis Refractory to Biologics: Select-psa 2

Mease, Philip J, Apinya Lertratanakul, Jaclyn K Anderson, Kim Papp, Filip Van den Bosch, Shigeyoshi Tsuji, Eva Dokoupilova, et al.. 2020. “Upadacitinib for Psoriatic Arthritis Refractory to Biologics: Select-psa 2”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2020-218870.

Rheumatology and TherapyJournal

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-week Data from the Randomized Controlled Phase 3 Select-psa 2 Study

Mease, Philip J., Apinya Lertratanakul, Kim A. Papp, Filip E. van den Bosch, Shigeyoshi Tsuji, Eva Dokoupilova, Mauro W. Keiserman, et al.. 2021. “Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-week Data from the Randomized Controlled Phase 3 Select-psa 2 Study”. Rheumatology and Therapy. Springer Science and Business Media LLC. doi:10.1007/s40744-021-00305-z.

Rheumatology and TherapyJournal

Patient-reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-modifying Antirheumatic Drugs: Select-psa 2

Strand, Vibeke, Filip Van den Bosch, Roberto Ranza, Ying-Ying Leung, Edit Drescher, Patrick Zueger, Christopher D. Saffore, Apinya Lertratanakul, Ralph Lippe, and Peter Nash. 2021. “Patient-reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-modifying Antirheumatic Drugs: Select-psa 2”. Rheumatology and Therapy. Springer Science and Business Media LLC. doi:10.1007/s40744-021-00377-x.

RheumatologyJournal