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Janus Kinase (JAK) Inhibitor

Upadacitinib for Axial Spondyloarthritis (SELECT-AXIS 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

Study 1 and Study 2: Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.

Study 1: Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS, Must not have total spinal ankylosis Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor [TNF] inhibitor or 1 interleukin [IL]-17 inhibitor [IL-17i]), and must have discontinued the bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to two bDMARDs was allowed for no more than 30% of patients; among patients with prior exposure to two bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was permitted, but a patient could not have a lack of efficacy to two bDMARDs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24, week 32, week 40, and week 52

Awards & highlights

SELECT-AXIS 2 Trial Summary

This trial has two parts. In the first part, people with active axial spondyloarthritis who haven't responded well to other treatments will be given upadacitinib or a placebo. In the second part, people with non-radiographic axial spondyloarthritis will be given the drug or a placebo. The objective is to see if upadacitinib is effective in reducing signs and symptoms, and if it is safe and well-tolerated.

Who is the study for?

Adults with active axial spondyloarthritis, including those who didn't respond well to certain rheumatic disease treatments (bDMARDs), can join this trial. Participants must have a specific level of disease activity and back pain, and not be fully fused in the spine due to ankylosis. They shouldn't have used JAK inhibitors before or be allergic to study drug ingredients.Check my eligibility

What is being tested?

The trial is testing Upadacitinib's effectiveness compared to a placebo in reducing symptoms for two groups: one with ankylosing spondylitis (AS) that didn’t respond well to bDMARDs, and another with non-radiographic axial spondyloarthritis (nr-axSpA). It also looks at how safe and tolerable the drug is over time.See study design

What are the potential side effects?

While not specified here, common side effects of drugs like Upadacitinib may include infections, headaches, high blood pressure, nausea, and potential liver enzyme elevations. Each person’s reaction can vary.

SELECT-AXIS 2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My back pain and ankylosing spondylitis symptoms are moderate to severe.

Select...

I have ankylosing spondylitis, tried 1-2 bDMARDs without success or couldn't tolerate them.

SELECT-AXIS 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24, week 32, week 40, and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24, week 32, week 40, and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24, week 32, week 40, and week 52 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14

Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14

Secondary outcome measures

Study 1: Change From Baseline in ASAS Health Index at Week 14

Ankylosing spondylitis

+32 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-AXIS 2 Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Study 2: Upadacitinib 15 mgExperimental Treatment1 Intervention

Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).

Group II: Study 1: Upadacitinib 15 mgExperimental Treatment1 Intervention

Group III: Study 1: PlaceboPlacebo Group2 Interventions

Participants receive matching placebo for 14 weeks and then switch to receive 15 mg upadacitinib orally once a day for 90 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).

Group IV: Study 2: PlaceboPlacebo Group2 Interventions

Participants receive matching placebo for 52 weeks and then switch to receive 15 mg upadacitinib orally once a day for 52 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,371 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,205 Total Patients Enrolled

Media Library

Upadacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04169373 — Phase 3

Spondyloarthritis Research Study Groups: Study 1: Upadacitinib 15 mg, Study 2: Upadacitinib 15 mg, Study 1: Placebo, Study 2: Placebo

Spondyloarthritis Clinical Trial 2023: Upadacitinib Highlights & Side Effects. Trial Name: NCT04169373 — Phase 3

Upadacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04169373 — Phase 3

Frequently Asked Questions

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

For what conditions is Upadacitinib most regularly given to patients?

"Systemic therapy candidates are the primary patients that upadacitinib is used to treat. That said, this medication can also help those with rheumatoid arthritis, methotrexate resistance, and other conditions where conventional treatments have failed."

Answered by AI

What are some of the dangers that have been associated with taking Upadacitinib?

"Upadacitinib has been studied in multiple Phase 3 trials, meaning that there is significant evidence for both its efficacy and safety. Consequently, our team at Power has given it a score of 3 on our safety scale."

Answered by AI

Could you share some more information about other research studies that have used Upadacitinib?

"At this moment, there are 21 ongoing clinical trials evaluating the efficacy of Upadacitinib. The majority of these studies are in Phase 3 and taking place in Singapore. However, globally, there are 3924 medical centres conducting research on Upadacitinib."

Answered by AI

How many trial locations are active at this time?

"This trial currently has 49 patients enrolled, with recruitment happening at Great Lakes Clinical Trials /ID# 215790 in Chicago, JPS Rheumatology Clinic /ID# 215962 in Fort Worth, and Centre de Recherche Musculo-Squelettique /ID# 215096 in Trois-rivières. There are also 49 other clinical trial sites across the globe."

Answered by AI