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A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) (SELECT - PsA 2)

Primary Purpose

Psoriatic Arthritis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Upadacitinib

Placebo

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Arthritis, Psoriasis, Anti-Rheumatic, Anti-inflammatory, Joint disease, Musculoskeletal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.

Exclusion Criteria:

Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), apremilast, hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Sites / Locations

Alabama Medical Group, PC /ID# 159836
AZ Arthritis & Rheum Research /ID# 160047
SunValley Arthritis Center, Lt /ID# 161203
AZ Arthritis and Rheumotology Research, PLLC /ID# 160006
Covina Arthritis Clinic /ID# 159919
TriWest Research Associates /ID# 159915
Saint Jude Heritage /ID# 160005
C.V. Mehta MD, Med Corporation /ID# 161192
Care Access Research, Huntingt /ID# 160049
Kotha and Kotha /ID# 159834
Stanford University School of Med /ID# 161402
Inland Rheum Clin Trials Inc. /ID# 159839
Medvin Clinical Research /ID# 160045
Denver Arthritis Clinic /ID# 159899
Arthritis & Rheumatic Disease Specialties /ID# 161409
Clinical Res of West FL, Inc. /ID# 159840
International Medical Research - Daytona /ID# 160051
Precision Research Org, LLC /ID# 161293
Suncoast Clinical Research /ID# 161417
Millennium Research /ID# 159833
Arthritis Center, Inc. /ID# 163463
Gulf Region Clinical Res Inst /ID# 159860
BayCare Medical Group /ID# 161405
Sarasota Arthritis Center /ID# 159854
W. Broward Rheum Assoc Inc. /ID# 161412
Clinical Research of West Florida, Inc /ID# 160069
USF Health Morsani Center for /ID# 161291
BayCare Medical Group, Inc. /ID# 159912
Florida Medical Clinic /ID# 160013
Atlanta Research Center for Rheumatology /ID# 161201
Great Lakes Clinical Trials /ID# 163438
Clinical Investigation Specialists - Skokie /ID# 160068
Deerbrook Medical Associates /ID# 159815
The Arthritis & Diabetes Clinic, Inc. /ID# 161294
The Center for Rheumatology & Bone Research /ID# 159900
Clinical Pharma Study Group /ID# 158712
Clinvest Research LLC /ID# 161208
Westroads Clinical Research /ID# 160004
Atlantic Coast Research /ID# 159810
Arthritis and Osteo Assoc /ID# 160015
The Center for Rheumatology /ID# 167046
St. Lawrence Health System /ID# 159857
DJL Clinical Research, PLLC /ID# 161414
PMG Research of Wilmington LLC /ID# 161403
Trinity Health Med Arts Clinic /ID# 159811
STAT Research, Inc. /ID# 161416
Health Research of Oklahoma /ID# 159913
Altoona Ctr Clinical Res /ID# 159861
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462
Rheumatology Consultants, PLLC /ID# 161408
Dr. Ramesh Gupta /ID# 160067
Tekton Research, Inc. /ID# 160008
Diagnostic Group Integrated He /ID# 161406
Adriana Pop-Moody MD Clinic PA /ID# 160009
Metroplex Clinical Research /ID# 159818
Accurate Clinical Research /ID# 160052
P&I Clinical Research /ID# 159837
SW Rheumatology Res. LLC /ID# 160014
DM Clinical Research /ID# 161753
Arthritis & Osteoporosis Clinic /ID# 161400
Swedish Medical Center /ID# 159918
UZ Ghent /ID# 164210
Reuma clinic /ID# 164214
CIP - Centro Internacional de Pesquisa /ID# 161808
Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794
Hospital de Clinicas de Porto Alegre /ID# 161795
LMK Sevicos Medicos S/S /ID# 161806
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163317
Faculdade de Medicina do ABC /ID# 163489
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 161793
Percuro Clinical Research, Ltd /ID# 157835
Ciads /Id# 157843
The Waterside Clinic /ID# 157838
Groupe de Recherche en Maladies Osseuses Inc /ID# 157836
Ctr. de Recherche Musculo-Sque /ID# 163557
CTR Estudios SpA /ID# 206038
Centro Inter Estud Clin CIEC /ID# 169543
Prosalud Ltda. /ID# 169542
Clinica Dermacross S.A /ID# 169537
Revmatologie Bruntal, s.r.o /ID# 159632
Medical Plus, s.r.o. /ID# 159631
Hopital Saint Joseph /ID# 163755
CHU Toulouse /ID# 163743
Hopital Lariboisiere /ID# 163773
Hopital Trousseau /ID# 163772
General Hospital of Athens Laiko /ID# 163474
Naval Hospital of Athens /ID# 163495
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170911
Revita Reumatologiai Rendelo /ID# 162575
Debreceni Egyetem Kenezy Gyula /ID# 162572
MAV Korhaz ess Rendelointezet /ID# 162574
Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 162571
Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 162751
A.O. Univ. Ospedali Riuniti /ID# 162748
Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 164126
ASST G. Pini /ID# 164125
Nagoya City University Hospital /ID# 162563
Fukuoka University Hospital /ID# 161774
Kitakyushu Municipal Medical Center /ID# 163516
Asahikawa Medical University Hospital /ID# 200684
Mie University Hospital /ID# 162085
Tohoku University Hospital /ID# 164035
Oribe Clinic of Rheumatism and Medicine /ID# 163704
Kansai Medical University Hospital /ID# 162081
National Hospital Organization Osaka Minami Medical Center /ID# 162589
Osaka City University Hospital /ID# 162082
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
Juntendo University Hospital /ID# 162089
St.Luke's International Hospital /ID# 162013
Keio University Hospital /ID# 162130
Daido Hospital /ID# 163639
Erasmus Medisch Centrum /ID# 163052
Maasstad Ziekenhuis /ID# 163050
Waikato Hospital /ID# 166412
Middlemore Hospital /ID# 166411
Porter Rheumatology Ltd /ID# 200422
Timaru Rheumatology Studies /ID# 166410
Instituto Portugues De Reumatologia /ID# 165894
Centro Hospitalar Lisboa Ocidental, EPE /ID# 165896
Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165897
Centro Hospitalar Lisboa Norte, EPE /ID# 165895
Unidade Local De Saude Do Alto Minho /ID# 165898
Ponce School of Medicine /ID# 163918
GCM Medical Group, PSC /ID# 163716
Hospital Universitario A Coruña - CHUAC /ID# 161019
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138
Hospital Universitario Reina Sofia /ID# 170764
Royal United Hospitals Bath /ID# 161054
Whipps Cross Univ Hospital /ID# 161053
Luton & Dunstable University Hospital /ID# 162713

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Upadacitinib 15 mg

Upadacitinib 30 mg

Placebo then Upadacitinib 15 mg

Placebo then Upadacitinib 30 mg

Arm Description

Period 1: Participants receive upadacitinib 15 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Period 1: Participants receive upadacitinib 30 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Outcomes

Primary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

Secondary Outcome Measures

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16

The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16

PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked). The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score.

Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12

The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.

Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24

A participant was classified as achieving MDA if 5 of the following 7 criteria were met: Tender joint count (out of 68 joints) ≤ 1 Swollen joint count (out of 66 joints) ≤ 1 PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3% Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10) Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10) HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3) Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)

Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16

The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2

Full Information

NCT ID

NCT03104374

First Posted

April 4, 2017

Last Updated

September 9, 2022

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03104374

Brief Title

A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)

Acronym

SELECT - PsA 2

Official Title

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) - SELECT - PsA 2

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

July 23, 2019 (Actual)

Study Completion Date

March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug (bDMARD). The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants who have completed Period 1.

Detailed Description

The study includes a 35-day screening period, a 56-week blinded period (Period 1), a long-term extension period of up to a total treatment duration of approximately 3 years (Period 2), and a 30-day follow-up call or visit. Period 1 includes 24 weeks of randomized, double-blind, parallel-group, placebo-controlled treatment followed by an additional 32 weeks of blinded treatment where all participants were to receive upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment. Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups: Group 1: Upadacitinib 15 mg Group 2: Upadacitinib 30 mg Group 3: Placebo for 24 weeks followed by upadacitinib 15 mg Group 4: Placebo for 24 weeks followed by upadacitinib 30 mg Participants who complete the Week 56 visit (end of Period 1) will enter the long-term extension portion of the study, Period 2, and continue study treatment as assigned in Period 1 in a blinded manner until the last participant completes the last visit of Period 1 (Week 56), when study drug assignment in both periods will be unblinded and study drug will be dispensed in an open-label fashion until the completion of Period 2. At Week 16, rescue therapy will be offered to participants classified as non-responders (defined as not achieving at least 20% improvement in tender joint count (TJC) and/or swollen joint count (SJC) at both Week 12 and Week 16). Starting at Week 36, participants who fail to demonstrate at least 20% improvement in either or both TJC and SJC compared to Baseline at 2 consecutive visits will be discontinued from study drug treatment. Additionally, in participants continuing on study drug, starting at the Week 36 visit, initiation of or change in background PsA medication(s) is allowed as per local label.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

Arthritis, Psoriasis, Anti-Rheumatic, Anti-inflammatory, Joint disease, Musculoskeletal disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

642 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Upadacitinib 15 mg

Arm Type

Experimental

Arm Description

Period 1: Participants receive upadacitinib 15 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Arm Title

Upadacitinib 30 mg

Arm Type

Experimental

Arm Description

Period 1: Participants receive upadacitinib 30 mg once daily for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Arm Title

Placebo then Upadacitinib 15 mg

Arm Type

Placebo Comparator

Arm Description

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 15 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.

Arm Title

Placebo then Upadacitinib 30 mg

Arm Type

Placebo Comparator

Arm Description

Period 1: Participants receive placebo once daily for 24 weeks followed by upadacitinib 30 mg once daily for 32 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.

Intervention Type

Drug

Intervention Name(s)

Upadacitinib

Other Intervention Name(s)

ABT-494, Rinvoq

Intervention Description

Oral tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablet

Primary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24

Description

Time Frame

Week 24

Title

Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2

Description

Time Frame

Baseline and Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits Diagnosis of active plaque psoriasis or documented history of plaque psoriasis Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD. Exclusion Criteria: Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib) Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), apremilast, hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline. History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Alabama Medical Group, PC /ID# 159836

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608-1787

Country

United States

Facility Name

AZ Arthritis & Rheum Research /ID# 160047

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

SunValley Arthritis Center, Lt /ID# 161203

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

AZ Arthritis and Rheumotology Research, PLLC /ID# 160006

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032-9306

Country

United States

Facility Name

Covina Arthritis Clinic /ID# 159919

City

Covina

State/Province

California

ZIP/Postal Code

91722

Country

United States

Facility Name

TriWest Research Associates /ID# 159915

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

Saint Jude Heritage /ID# 160005

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

C.V. Mehta MD, Med Corporation /ID# 161192

City

Hemet

State/Province

California

ZIP/Postal Code

92543

Country

United States

Facility Name

Care Access Research, Huntingt /ID# 160049

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Kotha and Kotha /ID# 159834

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Stanford University School of Med /ID# 161402

City

Stanford

State/Province

California

ZIP/Postal Code

94305-2200

Country

United States

Facility Name

Inland Rheum Clin Trials Inc. /ID# 159839

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Medvin Clinical Research /ID# 160045

City

Whittier

State/Province

California

ZIP/Postal Code

90606

Country

United States

Facility Name

Denver Arthritis Clinic /ID# 159899

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Arthritis & Rheumatic Disease Specialties /ID# 161409

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Clinical Res of West FL, Inc. /ID# 159840

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

International Medical Research - Daytona /ID# 160051

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Precision Research Org, LLC /ID# 161293

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016-1501

Country

United States

Facility Name

Suncoast Clinical Research /ID# 161417

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Millennium Research /ID# 159833

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Arthritis Center, Inc. /ID# 163463

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Gulf Region Clinical Res Inst /ID# 159860

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32514

Country

United States

Facility Name

BayCare Medical Group /ID# 161405

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Sarasota Arthritis Center /ID# 159854

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

W. Broward Rheum Assoc Inc. /ID# 161412

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Clinical Research of West Florida, Inc /ID# 160069

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606-1246

Country

United States

Facility Name

USF Health Morsani Center for /ID# 161291

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

BayCare Medical Group, Inc. /ID# 159912

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614-7101

Country

United States

Facility Name

Florida Medical Clinic /ID# 160013

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Atlanta Research Center for Rheumatology /ID# 161201

City

Marietta

State/Province

Georgia

ZIP/Postal Code

20060

Country

United States

Facility Name

Great Lakes Clinical Trials /ID# 163438

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Clinical Investigation Specialists - Skokie /ID# 160068

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

Facility Name

Deerbrook Medical Associates /ID# 159815

City

Vernon Hills

State/Province

Illinois

ZIP/Postal Code

60061

Country

United States

Facility Name

The Arthritis & Diabetes Clinic, Inc. /ID# 161294

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

The Center for Rheumatology & Bone Research /ID# 159900

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Clinical Pharma Study Group /ID# 158712

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

Facility Name

Clinvest Research LLC /ID# 161208

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65810-2607

Country

United States

Facility Name

Westroads Clinical Research /ID# 160004

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Atlantic Coast Research /ID# 159810

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Arthritis and Osteo Assoc /ID# 160015

City

Las Cruces

State/Province

New Mexico

ZIP/Postal Code

88011

Country

United States

Facility Name

The Center for Rheumatology /ID# 167046

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

St. Lawrence Health System /ID# 159857

City

Potsdam

State/Province

New York

ZIP/Postal Code

13676

Country

United States

Facility Name

DJL Clinical Research, PLLC /ID# 161414

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210-8508

Country

United States

Facility Name

PMG Research of Wilmington LLC /ID# 161403

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Trinity Health Med Arts Clinic /ID# 159811

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

STAT Research, Inc. /ID# 161416

City

Vandalia

State/Province

Ohio

ZIP/Postal Code

45377-9464

Country

United States

Facility Name

Health Research of Oklahoma /ID# 159913

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103-2400

Country

United States

Facility Name

Altoona Ctr Clinical Res /ID# 159861

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29486-7887

Country

United States

Facility Name

Rheumatology Consultants, PLLC /ID# 161408

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Dr. Ramesh Gupta /ID# 160067

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Tekton Research, Inc. /ID# 160008

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Diagnostic Group Integrated He /ID# 161406

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77701

Country

United States

Facility Name

Adriana Pop-Moody MD Clinic PA /ID# 160009

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Metroplex Clinical Research /ID# 159818

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Accurate Clinical Research /ID# 160052

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

P&I Clinical Research /ID# 159837

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904-3132

Country

United States

Facility Name

SW Rheumatology Res. LLC /ID# 160014

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

DM Clinical Research /ID# 161753

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Arthritis & Osteoporosis Clinic /ID# 161400

City

Waco

State/Province

Texas

ZIP/Postal Code

76710

Country

United States

Facility Name

Swedish Medical Center /ID# 159918

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

UZ Ghent /ID# 164210

City

Ghent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Reuma clinic /ID# 164214

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

CIP - Centro Internacional de Pesquisa /ID# 161808

City

Goiânia

State/Province

Goias

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794

City

Uberlândia

State/Province

Minas Gerais

ZIP/Postal Code

38400-902

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre /ID# 161795

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

LMK Sevicos Medicos S/S /ID# 161806

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90480-000

Country

Brazil

Facility Name

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163317

City

Ribeirao Preto

State/Province

Sao Paulo

ZIP/Postal Code

14049-900

Country

Brazil

Facility Name

Faculdade de Medicina do ABC /ID# 163489

City

Santo André

State/Province

Sao Paulo

ZIP/Postal Code

09060-870

Country

Brazil

Facility Name

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 161793

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Percuro Clinical Research, Ltd /ID# 157835

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3M9

Country

Canada

Facility Name

Ciads /Id# 157843

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3N 0K6

Country

Canada

Facility Name

The Waterside Clinic /ID# 157838

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

Groupe de Recherche en Maladies Osseuses Inc /ID# 157836

City

Sainte-foy

State/Province

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Ctr. de Recherche Musculo-Sque /ID# 163557

City

Trois-rivières

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

CTR Estudios SpA /ID# 206038

City

Providencia

ZIP/Postal Code

7500571

Country

Chile

Facility Name

Centro Inter Estud Clin CIEC /ID# 169543

City

Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Prosalud Ltda. /ID# 169542

City

Santiago

ZIP/Postal Code

ZC:7510047

Country

Chile

Facility Name

Clinica Dermacross S.A /ID# 169537

City

Vitacura Santiago

ZIP/Postal Code

7640881

Country

Chile

Facility Name

Revmatologie Bruntal, s.r.o /ID# 159632

City

Bruntál

ZIP/Postal Code

79201

Country

Czechia

Facility Name

Medical Plus, s.r.o. /ID# 159631

City

Uherské Hradište

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Hopital Saint Joseph /ID# 163755

City

Marseille CEDEX 08

State/Province

Bouches-du-Rhone

ZIP/Postal Code

13285

Country

France

Facility Name

CHU Toulouse /ID# 163743

City

Toulouse CEDEX 3

State/Province

Occitanie

ZIP/Postal Code

31025

Country

France

Facility Name

Hopital Lariboisiere /ID# 163773

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Hopital Trousseau /ID# 163772

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

General Hospital of Athens Laiko /ID# 163474

City

Athens

State/Province

Attiki

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Naval Hospital of Athens /ID# 163495

City

Athens

ZIP/Postal Code

11521

Country

Greece

Facility Name

Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170911

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Revita Reumatologiai Rendelo /ID# 162575

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

Debreceni Egyetem Kenezy Gyula /ID# 162572

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Facility Name

MAV Korhaz ess Rendelointezet /ID# 162574

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 162571

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 162751

City

Reggio Emilia

State/Province

Emilia-Romagna

ZIP/Postal Code

42123

Country

Italy

Facility Name

A.O. Univ. Ospedali Riuniti /ID# 162748

City

Ancona

State/Province

Marche

ZIP/Postal Code

60126

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 164126

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

ASST G. Pini /ID# 164125

City

Milan

ZIP/Postal Code

20122

Country

Italy

Facility Name

Nagoya City University Hospital /ID# 162563

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Fukuoka University Hospital /ID# 161774

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Kitakyushu Municipal Medical Center /ID# 163516

City

Kitakyushu-shi

State/Province

Fukuoka

ZIP/Postal Code

802-8561

Country

Japan

Facility Name

Asahikawa Medical University Hospital /ID# 200684

City

Asahikawa-shi

State/Province

Hokkaido

ZIP/Postal Code

078-8510

Country

Japan

Facility Name

Mie University Hospital /ID# 162085

City

Tsu-shi

State/Province

Mie

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

Tohoku University Hospital /ID# 164035

City

Sendai-shi

State/Province

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

Oribe Clinic of Rheumatism and Medicine /ID# 163704

City

Oita-shi

State/Province

Oita

ZIP/Postal Code

870-0823

Country

Japan

Facility Name

Kansai Medical University Hospital /ID# 162081

City

Hirakata-shi

State/Province

Osaka

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

National Hospital Organization Osaka Minami Medical Center /ID# 162589

City

Kawachinagano-shi

State/Province

Osaka

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

Osaka City University Hospital /ID# 162082

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

550-0006

Country

Japan

Facility Name

Juntendo University Hospital /ID# 162089

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

St.Luke's International Hospital /ID# 162013

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Keio University Hospital /ID# 162130

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Daido Hospital /ID# 163639

City

Nagoya

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Erasmus Medisch Centrum /ID# 163052

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Maasstad Ziekenhuis /ID# 163050

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

Waikato Hospital /ID# 166412

City

Hamilton

State/Province

Waikato

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Middlemore Hospital /ID# 166411

City

Auckland

ZIP/Postal Code

2025

Country

New Zealand

Facility Name

Porter Rheumatology Ltd /ID# 200422

City

Nelson

ZIP/Postal Code

7010

Country

New Zealand

Facility Name

Timaru Rheumatology Studies /ID# 166410

City

Timaru

ZIP/Postal Code

7910

Country

New Zealand

Facility Name

Instituto Portugues De Reumatologia /ID# 165894

City

Lisbon

State/Province

Lisboa

ZIP/Postal Code

1050-034

Country

Portugal

Facility Name

Centro Hospitalar Lisboa Ocidental, EPE /ID# 165896

City

Lisbon

State/Province

Lisboa

ZIP/Postal Code

1349-019

Country

Portugal

Facility Name

Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165897

City

Vila Nova De Gaia

State/Province

Porto

ZIP/Postal Code

4434-502

Country

Portugal

Facility Name

Centro Hospitalar Lisboa Norte, EPE /ID# 165895

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Unidade Local De Saude Do Alto Minho /ID# 165898

City

Viana Do Castelo

ZIP/Postal Code

4901-858

Country

Portugal

Facility Name

Ponce School of Medicine /ID# 163918

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

GCM Medical Group, PSC /ID# 163716

City

San Juan

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

Hospital Universitario A Coruña - CHUAC /ID# 161019

City

A Coruña

State/Province

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Hospital Universitario Reina Sofia /ID# 170764

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Royal United Hospitals Bath /ID# 161054

City

Bath

State/Province

Bath And North East Somerset

ZIP/Postal Code

BA1 1RL

Country

United Kingdom

Facility Name

Whipps Cross Univ Hospital /ID# 161053

City

London

State/Province

London, City Of

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Luton & Dunstable University Hospital /ID# 162713

City

Luton

ZIP/Postal Code

LU4 0DZ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

33272960

Citation

Mease PJ, Lertratanakul A, Anderson JK, Papp K, Van den Bosch F, Tsuji S, Dokoupilova E, Keiserman M, Wang X, Zhong S, McCaskill RM, Zueger P, Pangan AL, Tillett W. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021 Mar;80(3):312-320. doi: 10.1136/annrheumdis-2020-218870. Epub 2020 Dec 3.

Results Reference

result

PubMed Identifier

35606663

Citation

Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.

Results Reference

derived

PubMed Identifier

34970731

Citation

Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.

Results Reference

derived

PubMed Identifier

34864911

Citation

Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.

Results Reference

derived

PubMed Identifier

34661885

Citation

Strand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.

Results Reference

derived

PubMed Identifier

34464029

Citation

Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.

Results Reference

derived

PubMed Identifier

33913086

Citation

Mease PJ, Lertratanakul A, Papp KA, van den Bosch FE, Tsuji S, Dokoupilova E, Keiserman MW, Bu X, Chen L, McCaskill RM, Zueger P, McDearmon-Blondell EL, Pangan AL, Tillett W. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Jun;8(2):903-919. doi: 10.1007/s40744-021-00305-z. Epub 2021 Apr 28.

Results Reference

derived

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