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Corticosteroid

Upadacitinib for Giant Cell Arteritis (SELECT-GCA 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

Diagnosis of giant cell arteritis (GCA) with specific criteria for diagnosis

Participants must have received treatment with >=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once daily (QD) at Baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 through week 52

Awards & highlights

SELECT-GCA Trial Summary

This trial is testing a new drug to see if it can help people with a certain kind of arthritis. The trial will last for a year and will compare the new drug to a placebo.

Who is the study for?

This trial is for adults with Giant Cell Arteritis (GCA) who've been treated with high-dose steroids. They must have stable GCA suitable for a steroid tapering regimen and not have used JAK inhibitors or IL-6 inhibitors recently. Women must be non-reproductive or use birth control.Check my eligibility

What is being tested?

The study tests Upadacitinib's effectiveness and safety in GCA patients, comparing a combination of the drug with a 26-week steroid taper to placebo with a longer, 52-week taper. It also examines if continuing Upadacitinib maintains remission after initial success.See study design

What are the potential side effects?

Potential side effects may include infections due to immune system suppression, liver issues, blood clots, cholesterol changes, gastrointestinal problems, and allergic reactions related to Upadacitinib.

SELECT-GCA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with giant cell arteritis.

Select...

I have been treated with high-dose steroids before and am currently on a daily dose.

Select...

My giant cell arteritis is currently active or has returned recently.

SELECT-GCA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12 through week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12 through week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 through 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

Percentage of Participants Achieving Sustained Remission

Secondary outcome measures

Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale

Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Change from Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Score (PCS)

+7 more

SELECT-GCA Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm BExperimental Treatment2 Interventions

Upadacitinib dose B administered daily + 26-week CS taper regimen

Group II: Arm AExperimental Treatment2 Interventions

Upadacitinib dose A administered daily + 26-week CS taper regimen

Group III: Arm CPlacebo Group2 Interventions

Placebo administered daily + 52-week CS taper regimen

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~9670

Corticosteroid (CS)

2015

Completed Phase 4

~110

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,676 Total Patients Enrolled

1 Trials studying Giant Cell Arteritis

181 Patients Enrolled for Giant Cell Arteritis

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,510 Total Patients Enrolled

1 Trials studying Giant Cell Arteritis

181 Patients Enrolled for Giant Cell Arteritis

Media Library

Corticosteroid (CS) (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03725202 — Phase 3

Giant Cell Arteritis Research Study Groups: Arm C, Arm A, Arm B

Giant Cell Arteritis Clinical Trial 2023: Corticosteroid (CS) Highlights & Side Effects. Trial Name: NCT03725202 — Phase 3

Corticosteroid (CS) (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03725202 — Phase 3

Frequently Asked Questions

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

What are some of the common reasons that patients are prescribed Upadacitinib?

"Upadacitinib is a potential systemic therapy for patients with rheumatoid arthritis that have not responded to treatment with methotrexate."

Answered by AI

How many people fit the participant criteria for this research project?

"In order to carry out this clinical trial, researchers need to recruit 420 eligible patients from various locations such as St. Joseph's Healthcare in Hamilton, Ontario and West Tennessee Research Institute in Jackson, Tennessee."

Answered by AI

Is this research being conducted mostly in the United States or are there other countries participating as well?

"30 hospitals are participating in this study, some of which are St. Joseph's Healthcare /ID# 204160 in Hamilton, West Tennessee Research Institute /ID# 209256 in Jackson, and Louisiana State Univ HSC /ID# 202646 in Shreveport."

Answered by AI

Have there been other similar studies to this one before?

"Research for Upadacitinib began in 2015 with a clinical trial sponsored by AbbVie. After the success of the first trial, which had 1629 participants, Upadacitinib received Phase 3 approval in 2015. Currently, there are 21 active clinical trials being conducted in 953 cities and 54 countries."

Answered by AI

When will Upadacitinib be available for purchase by consumers?

"Like all Phase 3 drugs, Upadacitinib has undergone multiple rounds of testing to confirm both its efficacy and safety."

Answered by AI

Can you give some examples of similar research to Upadacitinib?

"Upadacitinib was first studied in 2015 at the Dr. I. Cantacuzino Clinic in Spitalul. Since then, there have been 18253 completed clinical trials worldwide. As of now, there are 21 studies actively recruiting patients, many of which are based in Hamilton, Ontario."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

2019. "A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03725202.

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