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Tumor Necrosis Factor (TNF) Inhibitor

Upadacitinib vs. Adalimumab for Psoriatic Arthritis (SELECT - PsA 1 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

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

Participant has active disease at Baseline defined as >= 3 tender joints and >= 3 swollen joints at Screening and Baseline Visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

SELECT - PsA 1 Trial Summary

This trial will compare the effectiveness of two doses of a new drug, upadacitinib, to a placebo and to the drug adalimumab, in people with psoriatic arthritis who have not responded well to other treatments. The trial will also look at the long-term safety and effectiveness of upadacitinib.

Who is the study for?

This trial is for people with active psoriatic arthritis who haven't responded well to treatments like methotrexate or sulfasalazine. They should have at least 3 tender and swollen joints, a history of plaque psoriasis, and higher than normal levels of inflammation markers. Those with other types of inflammatory joint diseases or previous JAK inhibitor use can't participate.Check my eligibility

What is being tested?

The study tests two doses of Upadacitinib against a placebo and Adalimumab in those with moderate to severe psoriatic arthritis unresponsive to non-biologic DMARDs. It aims to assess effectiveness in symptom relief and preventing joint damage over time.See study design

What are the potential side effects?

Upadacitinib may cause side effects such as infections, liver issues, blood clots, cholesterol changes, gastrointestinal perforations among others. Adalimumab's side effects include injection site reactions, headaches, rash and serious infections.

SELECT - PsA 1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with Psoriatic Arthritis for at least 6 months.

Select...

I have at least 3 tender and 3 swollen joints currently.

Select...

I have at least 3 tender and 3 swollen joints.

Select...

I have been diagnosed with plaque psoriasis.

Select...

I have been diagnosed with plaque psoriasis.

SELECT - PsA 1 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

Rheumatoid Factor

Secondary outcome measures

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

Change From Baseline in HAQ-DI - Superiority Versus Adalimumab

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

+14 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 1 Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Upadacitinib 30 mgExperimental Treatment2 Interventions

Period 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Group II: Upadacitinib 15 mgExperimental Treatment2 Interventions

Period 1: Participants receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Group III: AdalimumabActive Control2 Interventions

Period 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks. Period 2: Participants continue to receive adalimumab 40 mg every other week.

Group IV: Placebo / Upadacitinib 15 mgPlacebo Group3 Interventions

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Group V: Placebo / Upadacitinib 30 mgPlacebo Group3 Interventions

Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

FDA approved

Placebo to Adalimumab

2010

Completed Phase 3

~120

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

499,400 Total Patients Enrolled

22 Trials studying Psoriatic Arthritis

107,200 Patients Enrolled for Psoriatic Arthritis

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

99,852 Total Patients Enrolled

11 Trials studying Psoriatic Arthritis

12,365 Patients Enrolled for Psoriatic Arthritis

Media Library

Adalimumab (Tumor Necrosis Factor (TNF) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03104400 — Phase 3

Psoriatic Arthritis Research Study Groups: Upadacitinib 15 mg, Placebo / Upadacitinib 15 mg, Upadacitinib 30 mg, Adalimumab, Placebo / Upadacitinib 30 mg

Psoriatic Arthritis Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT03104400 — Phase 3

Adalimumab (Tumor Necrosis Factor (TNF) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03104400 — Phase 3

Frequently Asked Questions

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

What is the status of ABT-494's FDA application?

"There is both clinical evidence and multiple rounds of data supporting ABT-494's safety, so it received a score of 3."

Answered by AI

What other research studies have been conducted using ABT-494?

"Currently, there are 69 different clinical trials studying ABT-494 with 26 of them in Phase 3. The capital of the United Kingdom, London, is home to many of these trials. However, there are 5292 total locations running clinical trials for ABT-494."

Answered by AI

Are there any remaining empty slots for test subjects in this experiment?

"As of now, this trial has no open positions. The study was first posted on April 27th, 2017 and updated on September 9th, 2022. However, there are 425 other clinical trials for psoriatic arthritis and 69 for ABT-494 that are actively recruiting patients."

Answered by AI

For what reason would a doctor prescribe ABT-494?

"ABT-494 is frequently used to help patients that haven't responded well to other forms of therapy. Additionally, it can be used to treat dermatitis, atopic, psoriatic arthritis, polyarticular juvenile idiopathic arthritis."

Answered by AI

Are there any limitations to how many people can be in this research project?

"This research is not currently enrolling individuals. According to the study's page on clinicaltrials.gov, it was originally posted on April 27th, 2017 and was last updated on September 9th, 2022. There are presently 425 studies actively searching for patients with psoriatic arthritis and 69 trials for ABT-494 actively recruiting participants."

Answered by AI

What benefits does this experiment hope to bring patients?

"According to the sponsoring pharmaceutical company, AbbVie, the primary goal of this study will be to measure the Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response over a Baseline and Week 12 period. Additionally, this trial will also observe secondary outcomes such as Change in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire, Change in HAQ-DI, and Change in Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)."

Answered by AI