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

Summary

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) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.

Timeline

Start

2019-01-24

Primary completion

2024-02-06

Completion

2025-03-11

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Placebo + 52-week CS Taper vs 15 mg Upadacitinib + 26-week CS Taper; p =0.0019; Adjusted Response Rate Difference 17.1 (95% CI 6.3 to 27.8) reads as mixed primary results NCT03725202 ↗

registry Placebo + 52-week CS Taper vs 7.5 mg Upadacitinib + 26-week CS Taper; p =0.0579; Adjusted Response Rate Difference 12.1 (95% CI -0.4 to 24.6) reads as mixed primary results NCT03725202 ↗

release “achieved its primary endpoint of sustained remission a from week 12 through week 52 in adults with giant cell arteritis (GCA).” reads as mixed primary results abbvie.com ↗

release “upadacitinib 7.5 mg did not meet the primary or any of the secondary endpoints.” reads as mixed primary results abbvie.com ↗

release “SELECT-GCA study demonstrating upadacitinib 15 mg with a 26-week steroid taper regimen achieved the primary endpoint of sustained remission” reads as met primary endpoint abbvie.com ↗

release “The approval is supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that RINVOQ achieved the primary endpoint of sustained remission*” reads as met primary endpoint abbvie.com ↗

release “The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission” reads as met primary endpoint abbvie.com ↗

release “The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that Rinvoq achieved the primary endpoint of sustained remission” reads as met primary endpoint abbvie.com ↗

Publications

• Blockmans D, Penn SK, Setty AR, Schmidt WA, Rubbert-Roth A, Hauge EM, Keen HI, Ishii T, Khalidi N, Dejaco C, Cid MC, Hellmich B, Liu M, Zhao W, Lagunes I, Romero AB, Wung PK, Merkel PA; SELECT-GCA Study Group. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. N Engl J Med. 2025 May 29;392(20):2013-2024. doi: 10.1056/NEJMoa2413449. Epub 2025 Apr 2.
• Loricera J, Tofade T, Prieto-Pena D, Romero-Yuste S, de Miguel E, Riveros-Frutos A, Ferraz-Amaro I, Labrador E, Maiz O, Becerra E, Narvaez J, Galindez-Agirregoikoa E, Gonzalez-Fernandez I, Urruticoechea-Arana A, Ramos-Calvo A, Lopez-Gutierrez F, Castaneda S, Unizony S, Blanco R. Effectiveness of janus kinase inhibitors in relapsing giant cell arteritis in real-world clinical practice and review of the literature. Arthritis Res Ther. 2024 Jun 5;26(1):116. doi: 10.1186/s13075-024-03314-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Upadacitinib	Small molecule	7.5 mg	Oral
Subject	Upadacitinib	Small molecule	15 mg	Oral
Background	Prednisolone	Other / unclassified	20 mg	Oral
Background	Prednisolone	Other / unclassified	30 mg	Oral
Background	Prednisolone	Other / unclassified	40 mg	Oral
Background	Prednisolone	Other / unclassified	50 mg	Oral
Background	Prednisolone	Other / unclassified	60 mg	Oral
Background	Prednisone	Other / unclassified	20 mg	Oral
Background	Prednisone	Other / unclassified	30 mg	Oral
Background	Prednisone	Other / unclassified	40 mg	Oral
Background	Prednisone	Other / unclassified	50 mg	Oral
Background	Prednisone	Other / unclassified	60 mg	Oral

Indications