Upadacitinib for Giant Cell Arteritis

(SELECT-GCA Trial)

No longer recruiting at 240 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Corticosteroids

Must not be taking: JAK inhibitors, IL-6 inhibitors

Disqualifiers: Infections, Pregnancy, Immunosuppressants, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of upadacitinib for individuals with giant cell arteritis (GCA), an inflammation of the blood vessels that often causes headaches and jaw pain. The study compares two treatment plans: one with upadacitinib and a shorter 26-week course of corticosteroids, and another with a placebo and a longer 52-week course of corticosteroids. Researchers seek to determine if upadacitinib can help patients maintain remission (symptom-free) and assess the drug's safety. Suitable candidates have active GCA and are already taking prednisone (a type of corticosteroid) daily. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting, such as interleukin-6 inhibitors, methotrexate, and others listed in the exclusion criteria. You must also be on a stable dose of prednisone (or equivalent) at the start of the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that upadacitinib, a treatment under study for giant cell arteritis (GCA), has generally been well-tolerated in previous studies. Some patients experienced side effects, but these were usually mild. Common side effects include nausea, headaches, and an increased risk of infections.

Upadacitinib is already approved for other conditions, indicating that its safety profile is well understood. However, it should not be taken with other similar drugs known as Janus kinase (JAK) inhibitors. Although past studies suggest it is safe, joining a clinical trial always involves some risks. Potential participants should discuss these risks with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about upadacitinib for treating Giant Cell Arteritis because it offers a different approach compared to traditional corticosteroid treatments. Most existing treatments rely heavily on corticosteroids, which can have significant long-term side effects. Upadacitinib works by targeting specific pathways in the immune system, specifically the Janus kinase (JAK) pathways, to reduce inflammation more precisely. This targeted mechanism may reduce the reliance on corticosteroids and potentially minimize their side effects, offering patients a promising new option for managing their condition.

What evidence suggests that this trial's treatments could be effective for giant cell arteritis?

Research has shown that upadacitinib can help people with giant cell arteritis (GCA) by reducing or eliminating symptoms. In this trial, participants in one arm will receive 15 mg of upadacitinib daily. Specifically, studies have shown that 46.4% of patients taking this dosage achieved remission, meaning their symptoms improved or disappeared without needing extra steroids from weeks 12 to 52. Participants in another arm will reduce their steroid use over 26 weeks while taking upadacitinib, and studies suggest they also maintained remission from week 12 through 52. This indicates that upadacitinib can effectively manage GCA and help reduce the need for steroids more quickly. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with giant cell arteritis.

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

My giant cell arteritis is stable enough to start reducing my steroid treatment.

Exclusion Criteria

I have previously taken a JAK inhibitor medication.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive upadacitinib or placebo with a corticosteroid taper regimen for 52 weeks

52 weeks

Regular visits as per protocol

Treatment Period 2

Participants continue or withdraw upadacitinib to evaluate maintenance of remission

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid (CS)
• Placebo
• Upadacitinib

Trial Overview 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.

How Is the Trial Designed?

Group I: 7.5 mg Upadacitinib + 26-week CS taper -> Placebo Experimental Treatment 1 Intervention

Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.

Group II: 7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg Upadacitinib Experimental Treatment 1 Intervention

Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.

Group III: 7.5 mg Upadacitinib + 26-week CS taper Experimental Treatment 2 Interventions

Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.

Group IV: 15 mg Upadacitinib + 26-week CS taper -> Placebo Experimental Treatment 1 Intervention

Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.

Group V: 15 mg Upadacitinib + 26-week CS taper -> 15 mg Upadacitinib Experimental Treatment 1 Intervention

Participants received 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.

Group VI: 15 mg Upadacitinib + 26-week CS taper Experimental Treatment 2 Interventions

Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.

Group VII: Placebo + 52-week CS taper Placebo Group 2 Interventions

Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.

Group VIII: Placebo + 52-week CS taper -> Placebo Placebo Group 1 Intervention

Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR at remission at the Week 52 visit only who were assigned to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a study of 498 patients with rheumatoid arthritis who did not respond adequately to biologic treatments, both doses of upadacitinib (15 mg and 30 mg) significantly improved patient-reported outcomes (PROs) such as pain, disability, and overall disease activity compared to placebo.

More patients taking upadacitinib reported clinically meaningful improvements in quality of life measures, with the number needed to treat (NNT) to achieve these improvements ranging from 4 to 7, indicating that upadacitinib is effective in enhancing the well-being of patients with rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Strand, V., Schiff, M., Tundia, N., et al.[2023]

In a 48-week study involving patients with rheumatoid arthritis, upadacitinib 15 mg daily was found to be more effective than adalimumab or placebo in improving disease symptoms and preventing joint damage when used alongside methotrexate.

Patients who switched from adalimumab to upadacitinib due to insufficient response showed a higher rate of achieving low disease activity compared to those switching from upadacitinib to adalimumab, indicating that upadacitinib may provide better outcomes for patients not responding to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. Fleischmann, RM., Genovese, MC., Enejosa, JV., et al.[2020]

In a study involving 596 patients from Central and Eastern Europe, upadacitinib 15 mg once daily showed significant efficacy in improving rheumatoid arthritis symptoms compared to placebo and adalimumab, with results maintained over 48 weeks.

While upadacitinib demonstrated clinical benefits, it also had a higher incidence of serious infections and herpes zoster compared to adalimumab, indicating a need for careful monitoring of safety in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib versus placebo or adalimumab with background methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate: a subgroup analysis of a phase III randomized controlled trial in Central and Eastern European patients. Pavelka, K., Szekanecz, Z., Damjanov, N., et al.[2022]

In a study involving 661 patients with rheumatoid arthritis (RA) who did not respond adequately to conventional DMARDs, upadacitinib (15 mg and 30 mg) significantly improved patient-reported outcomes such as pain, physical function, and overall disease activity after 12 weeks compared to placebo.

Patients taking upadacitinib reported clinically meaningful improvements in various measures, with the number needed to treat (NNT) for these benefits ranging from 4 to 8, indicating that a small number of patients need to be treated for one to experience significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Strand, V., Pope, J., Tundia, N., et al.[2021]

In a 48-week study involving patients with rheumatoid arthritis who did not respond adequately to methotrexate, upadacitinib showed significant improvements in patient-reported outcomes compared to placebo and was at least as effective as adalimumab.

Patients treated with upadacitinib reported greater reductions in pain, disability, and stiffness, with more individuals achieving clinically meaningful improvements across various measures compared to those on adalimumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE. Strand, V., Tundia, N., Bergman, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03725202

NCT03725202 | A Study to Evaluate the Safety and ... This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40174237/

A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis Results: A total of 209 patients received upadacitinib at a dose of 15 mg, 107 received upadacitinib at a dose of 7.5 mg, and 112 received ...

3. rinvoqhcp.com rinvoqhcp.com/giant-cell-arteritis/efficacy

RINVOQ® (upadacitinib) Efficacy for Giant Cell Arteritis Durable remission with rapid steroid reduction. GCA patients on a 26-wk CS taper achieved sustained remission from Week 12 through 52 (primary endpoint).

4. news.abbvie.com news.abbvie.com/2023-05-24-AbbVie-Presents-Long-Term-Data-Further-Supporting-the-Efficacy-and-Safety-Profile-of-RINVOQ-R-upadacitinib-Across-Multiple-Rheumatic-Diseases-at-the-EULAR-2023-Congress

AbbVie Presents Long-Term Data Further Supporting the ... A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis. clinicaltrials.gov; 2022. Available ...

5. the-rheumatologist.org the-rheumatologist.org/article/new-study-upadacitinib-is-treatment-option-for-giant-cell-arteritis/

New Study: Upadacitinib Is Treatment Option for Giant Cell ... It found that 46.4% of patients on 15 mg of upadacitinib daily achieved remission without any rescue glucocorticoids during weeks 12–52 in the ...

6. rinvoqhcp.com rinvoqhcp.com/dermatology/safety

RINVOQ® (upadacitinib) Safety Data Giant cell arteritis (GCA) in adults. Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic ...

7. rinvoqhcp.com rinvoqhcp.com/safety

RINVOQ® (upadacitinib) Safety Profile Giant cell arteritis (GCA) in adults. Limitations of Use: RINVOQ is not recommended for use in combination with other Janus kinase (JAK) inhibitors ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03725202

A Study to Evaluate the Safety and Efficacy of Upadacitinib ... This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) ...

9. rinvoq.com rinvoq.com/giant-cell-arteritis

RINVOQ® (upadacitinib) for Giant Cell Arteritis (GCA) RINVOQ is a prescription medicine used to treat adults with giant cell arteritis (GCA). IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib).

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7217812/

Clinical Pharmacokinetics of Upadacitinib: Review of Data ... Upadacitinib safety and efficacy were evaluated in two phase II dose-ranging studies in patients with RA who were inadequate responders to anti-tumor necrosis ...