Early access
Sign in
CompletedPhase 3

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

Key facts

Who runs it
AbbVie
Where
Allen, Ann Arbor, Atlanta, Austin, Baton Rouge, Boca Raton, Burlington, Chicago, Colleyville, Danbury, Denver, Detroit, Franklin, Glendale, Grand Blanc, Grand Rapids, Greenville, Huntsville, Idaho Falls, Jackson, Kennewick, Kingsport, Lincoln, Long Beach, Lubbock, Marietta, Miami, Milwaukee, Monroe, Naples, New Orleans, Orlando, Philadelphia, Plano, Plantation, Portland, Roanoke, Rochester, Seattle, Shreveport, Somerset, Springfield, Summerville, Tampa, Temple, Tustin, Vandalia, Venice, and Wheaton, United StatesSee the 53 sitesAlso in 23 other countries, 119 sites
Status
Completed
Phase
Phase 3
People taking part
429 people enrolled
Started
24 Jan 2019
Ended
11 Mar 2025
Type of study
Interventional, 8 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Upadacitinib
  • Corticosteroid (CS)
  • Placebo
Record updated
24 February 2026

Who can take part

Age
50 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Diagnosis of giant cell arteritis (GCA) according to the following criteria:; History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity C-reactive protein (hsCRP)/CRP >=1.0 mg/dL; Presence of at least one of the following: Unequivocal cranial symptoms of GCA or Unequivocal symptoms of polymyalgia rheumatica (PMR); Presence of at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large vessel vasculitis by angiography or cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET)
  • Active GCA, either new onset or relapsing, within 8 weeks of Baseline
  • 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
  • Participants must have GCA that, in the opinion of the investigator, is clinically stable to allow the participant to safely initiate the protocol-defined corticosteroid (CS) taper regimen
  • Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study

Who cannot take part

  • Prior exposure to any Janus Kinase (JAK) inhibitor
  • 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
  • Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start:; Anakinra within 1 week of study start; Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate within 4 weeks of study start; Oral corticosteroid (CS) for conditions other than GCA within 4 week of study start, or intravenous CS within 4 weeks of study start; Greater than or equal to 8 weeks for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure; Cell-depleting agents or alkylating agents including cyclophosphamide within 6 months of study start
  • Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C
  • Female who is pregnant, breastfeeding, or considering pregnancy during the study

Where in United States

Also in 23 other countries, 119 sites

  • Allen Arthritis /ID# 225527Allen, United States
  • University of Michigan Hospitals /ID# 168645Ann Arbor, United States
  • Arthritis and Rheumatology /ID# 170295Atlanta, United States
  • Tekton Research, L.L.C /ID# 201801Austin, United States
  • Ochsner Clinic Foundation /ID# 200723Baton Rouge, United States
  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040Boca Raton, United States
  • University of Vermont Medical Center /ID# 211179Burlington, United States
  • Duplicate_Rush University Medical Center /ID# 224581Chicago, United States
  • Precision Comprehensive Clinical Research Solutions /ID# 201798Colleyville, United States
  • Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071Danbury, United States
  • Denver Arthritis Clinic /ID# 171552Denver, United States
  • Henry Ford Medical Center - New Center One /ID# 207456Detroit, United States
  • Wayne State University Health Center /ID# 212755Detroit, United States
  • Aurora Rheumatology and Immunotherapy Center /ID# 201853Franklin, United States
  • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702Glendale, United States
  • Duplicate_AA Medical Research Center - Grand Blanc /ID# 201854Grand Blanc, United States
  • Duplicate_West Michigan Rheumatology /ID# 168647Grand Rapids, United States
  • Piedmont Arthritis Clinic, PA /ID# 212431Greenville, United States
  • Rheum Assoc of North Alabama /ID# 168668Huntsville, United States
  • Institute of Arthritis Research /ID# 168490Idaho Falls, United States
  • West Tennessee Research Institute /ID# 209256Jackson, United States
  • Kadlec Clinic Rheumatology /ID# 201618Kennewick, United States
  • Arthritis Associates of Kingsport /ID# 212756Kingsport, United States
  • Physician Research Collaboration, LLC /ID# 168610Lincoln, United States
  • VA Long Beach Healthcare System /ID# 203833Long Beach, United States
  • West Texas Clinical Research /ID# 204834Lubbock, United States
  • Marietta Memorial Hospital /ID# 210834Marietta, United States
  • Ctr Arthritis & Rheumatic Dise /ID# 168667Miami, United States
  • Lakes Research, LLC /ID# 210442Miami, United States
  • Froedtert Memorial Lutheran Hospital /ID# 224557Milwaukee, United States
  • The Arthritis & Diabetes Clinic, Inc. /ID# 171199Monroe, United States
  • Medallion Clinical Research Institute, LLC /ID# 168666Naples, United States
  • Ochsner Clinic Foundation-New Orleans /ID# 171200New Orleans, United States
  • Omega Research Group /ID# 201903Orlando, United States
  • University of Pennsylvania /ID# 168655Philadelphia, United States
  • Arthritis and Rheumatology Institute, PLLC /ID# 214612Plano, United States
  • IRIS Research and Development, LLC /ID# 169406Plantation, United States
  • Rheumatology Associates PA - Portland /ID# 225011Portland, United States
  • Carilion Clinic /ID# 212928Roanoke, United States
  • University of Rochester Medical Center /ID# 213527Rochester, United States
  • University of Washington /ID# 201619Seattle, United States
  • Louisiana State Univ HSC /ID# 202646Shreveport, United States
  • University Clinical Research Center /ID# 202504Somerset, United States
  • Clinvest Research LLC /ID# 208182Springfield, United States
  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 212761Summerville, United States
  • Clinical Research of West Florida - Tampa /ID# 201899Tampa, United States
  • Clinical Research of West Florida, Inc /ID# 201901Tampa, United States
  • Duplicate_University of South Florida /ID# 207077Tampa, United States
  • Baylor Scott & White Center for Diagnostic Medicine /ID# 213529Temple, United States
  • Robin K. Dore MD, Inc /ID# 201950Tustin, United States
  • STAT Research, Inc. /ID# 200436Vandalia, United States
  • Lovelace Scientific Resources /ID# 169041Venice, United States
  • The Center for Rheumatology and Bone Research /ID# 168652Wheaton, United States

About the trial

What the trial wants to find out

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.

The 8 groups in the trial

  • Placebo + 52-week CS taperPlacebo, for comparison

    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.

    Treatment: Corticosteroid (CS) and Placebo

  • 7.5 mg Upadacitinib + 26-week CS taperTreatment being tested

    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.

    Treatment: Upadacitinib and Corticosteroid (CS)

  • 15 mg Upadacitinib + 26-week CS taperTreatment being tested

    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.

    Treatment: Upadacitinib and Corticosteroid (CS)

  • Placebo + 52-week CS taper -> PlaceboPlacebo, for comparison

    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.

    Treatment: Placebo

  • 7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg UpadacitinibTreatment being tested

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

    Treatment: Upadacitinib

  • 7.5 mg Upadacitinib + 26-week CS taper -> PlaceboTreatment being tested

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

    Treatment: Placebo

  • 15 mg Upadacitinib + 26-week CS taper -> 15 mg UpadacitinibTreatment being tested

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

    Treatment: Upadacitinib

  • 15 mg Upadacitinib + 26-week CS taper -> PlaceboTreatment being tested

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

    Treatment: Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Giant Cell Arteritis: SELECT-GCA
Record updated
24 February 2026