What side effects are associated with this type of intervention?

The most common treatments for Giant Cell Arteritis (GCA) include corticosteroids and Janus kinase (JAK) inhibitors like Upadacitinib. Corticosteroids can cause side effects such as weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. JAK inhibitors, including Upadacitinib, may lead to side effects like upper respiratory infections, headache, nausea, increased creatine phosphokinase levels, and acne. Both treatments require careful monitoring due to their potential impact on the immune system and other bodily functions.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for Janus kinase (JAK) inhibitors like Upadacitinib for the treatment of Giant Cell Arteritis (GCA). The primary treatment for GCA typically involves corticosteroids to reduce inflammation. Tocilizumab, an interleukin-6 (IL-6) receptor antagonist, is one of the few FDA-approved drugs specifically for GCA. It is used in combination with a tapering course of corticosteroids to help maintain remission and reduce the need for long-term steroid use.

What other types of research exist?

Promising novel alternatives to Upadacitinib for Giant Cell Arteritis patients include other JAK inhibitors such as Tofacitinib and Ruxolitinib, which have shown efficacy in various inflammatory conditions. Additionally, biologic agents like Ustekinumab, an IL-12/23 inhibitor, and Risankizumab, an IL-23 inhibitor, could be considered based on their success in treating other autoimmune diseases.

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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

Must not have

Female who is pregnant, breastfeeding, or considering pregnancy during the study

Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12 through week 52

Awards & highlights

Pivotal Trial

Summary

This trial tests if upadacitinib, combined with reducing steroid doses, helps people with giant cell arteritis achieve and maintain remission by reducing inflammation. Upadacitinib has been approved for the treatment of rheumatoid arthritis, atopic dermatitis, and psoriatic arthritis, and is under investigation for other conditions.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Select...

I have not taken IL-6 inhibitors in the last 4 weeks or had a disease flare on them.

Select...

I have previously taken a JAK inhibitor medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving Sustained Remission

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

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

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

~11250

Corticosteroid (CS)

2015

Completed Phase 4

~110

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Giant Cell Arteritis (GCA) include corticosteroids and Janus kinase (JAK) inhibitors. Corticosteroids reduce inflammation by suppressing the immune system and inhibiting the production of inflammatory cytokines. JAK inhibitors, such as Upadacitinib, target the JAK-STAT signaling pathway, which is essential for the activity of various cytokines involved in inflammation. By inhibiting this pathway, JAK inhibitors can effectively reduce inflammation and immune response. These mechanisms are crucial for GCA patients as they help prevent severe complications like vision loss and large vessel damage, thereby improving patient outcomes.