A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE2)

August 11, 2025 updated by: AbbVie

A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. Period 2 is the long-term period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. Participants remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.

Study Type

Interventional

Enrollment (Actual)

444

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • San Miguel de Tucumán, Argentina, 4000
        • Cimer /Id# 169155
    • Ciuadad Autonoma de Buenos Aires
      • Buenos Aires, Ciuadad Autonoma de Buenos Aires, Argentina, 1221
        • Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
      • Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 208473
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina, 1111
        • DOM Centro de Reumatologia /ID# 208478
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto CAICI /ID# 169156
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Centro Medico Privado de Reumatologia /ID# 208342
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital /ID# 207591
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Rheumatology Research Unit Sunshine Coast /ID# 207191
      • Southport, Queensland, Australia, 4222
        • Griffith University /ID# 207504
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 207195
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre /ID# 208033
  • Belgium
      • Genk, Belgium, 3600
        • ReumaClinic /ID# 208211
      • Merksem, Belgium, 2170
        • ZNA - Jan Palfijn /ID# 208210
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 210037
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 208209
  • Brazil
    • Goiás
      • Goiânia, Goiás, Brazil, 74110-120
        • CIP - Centro Internacional de Pesquisa /ID# 169524
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Sevicos Medicos S/S /ID# 169541
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 169530
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3N 0K6
        • CIADS Research Co Ltd /ID# 169526
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Dermatrials Research /ID# 208303
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research /ID# 169527
    • Quebec
      • Rimouski, Quebec, Canada, G5L 8W1
        • Centre Rhumatologie de l'Est /ID# 208302
  • Denmark
    • Capital Region
      • Frederiksberg, Capital Region, Denmark, 2000
        • Bispebjerg and Frederiksberg Hospital /ID# 168763
    • Central Jutland
      • Aarhus C, Central Jutland, Denmark, 8000
        • Aarhus University Hospital /ID# 168762
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre /ID# 208319
    • Harju
      • Tallinn, Harju, Estonia, 10138
        • East Tallinn Central Hospital /ID# 208317
    • Tartu
      • Tartu, Tartu, Estonia, 50708
        • MediTrials /ID# 207815
  • Finland
      • Kuopio, Finland, 70100
        • Ite Pihlajanlinna Kuopio /ID# 208316
      • Turku, Finland, 20520
        • Turku University Hospital /ID# 208199
  • France
      • Bordeaux, France, 33076
        • Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
      • Chambray-lès-Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 209343
  • Germany
      • Buch, Germany, 13125
        • Immanuel Krankenhaus Berlin /ID# 207214
      • Frankfurt, Germany, 60590
        • Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494
      • Hamburg, Germany, 20095
        • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493
    • North Rhine-Westphalia
      • Herne, North Rhine-Westphalia, Germany, 44649
        • Rheumazentrum Ruhrgebiet /ID# 207212
  • Greece
      • Athens, Greece, 11521
        • Naval Hospital of Athens /ID# 206928
      • Pátrai, Greece, 26443
        • Olympion General Clinic SA /ID# 207047
    • Crete
      • Heraklion, Crete, Greece, 71307
        • University General Hospital of Heraklion PA.G.N.I /ID# 206930
  • Hungary
      • Budapest, Hungary, 1023
        • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3529
        • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237
    • Veszprém megye
      • Veszprém, Veszprém megye, Hungary, 8200
        • Vital-Medicina Kft. /ID# 208123
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center /ID# 207471
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 208169
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center /ID# 207469
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 207470
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5239424
        • Sheba Medical Center /ID# 207468
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
        • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 168450
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 168449
    • Provincie Friesland
      • Sneek, Provincie Friesland, Netherlands, 8601 ZK
        • Antonius Ziekenhuis /ID# 208581
  • New Zealand
      • Auckland, New Zealand, 2025
        • Middlemore Clinical Trials /ID# 214293
      • Burwood Christchurch, New Zealand, 8083
        • CGM Research Trust /ID# 210596
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • Waikato Hospital /ID# 214276
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-149
        • Malopolskie Centrum Kliniczne /ID# 208011
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-691
        • Centrum Medyczne Reuma Park w Warszawie /ID# 210956
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Osteo-Medic S.C. /ID# 208013
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Centrum Kliniczno-Badawcze /ID# 208014
  • Portugal
      • Lisbon, Portugal, 1050-034
        • Instituto Português De Reumatologia /ID# 208140
      • Lisbon, Portugal, 1649-035
        • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139
    • Viana do Castelo District
      • Ponte de Lima, Viana do Castelo District, Portugal, 4990-041
        • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138
  • Puerto Rico
      • San Juan, Puerto Rico, 00917-3104
        • GCM Medical Group PSC - Hato Rey /ID# 208461
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital /ID# 208966
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6405
        • Dr Jenny Potts /ID# 167628
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Arthritis Clinical Research Trials /ID# 167611
      • Stellenbosch, Western Cape, South Africa, 7600
        • Winelands Medical Research Centre /ID# 167630
  • Spain
      • A Coruña, Spain, 15006
        • Hospital Universitario A Coruna - CHUAC /ID# 207819
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 207820
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 207823
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Unversitario Marques de Valdecilla /ID# 208541
  • Sweden
      • Solna, Sweden, 171 64
        • Duplicate_Karolinska Univ Sjukhuset /ID# 208174
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital /ID# 169098
      • Västerås, Sweden, 723 35
        • Duplicate_Vastmanlands Sjukhus /ID# 168620
    • Örebro County
      • Örebro, Örebro County, Sweden, 701 85
        • Orebro Universitetssjukhuset /ID# 169400
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust /ID# 207923
      • Metropolitan Borough of Wirral, United Kingdom, CH49 5PE
        • Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536
      • Torquay, United Kingdom, TQ2 7AA
        • Torbay and South Devon Nhs Foundation Trust /Id# 207926
    • London, City of
      • London, London, City of, United Kingdom, E11 1NR
        • Duplicate_Barts Health NHS Trust /ID# 210794
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group /ID# 167953
    • California
      • Fullerton, California, United States, 92835
        • St. Jude Heritage /ID# 166842
      • Huntington Beach, California, United States, 92648-5994
        • Newport Huntington Medica /ID# 207423
      • La Palma, California, United States, 90623-1728
        • Arthritis & Osteo Medical Ctr /ID# 166541
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology Medical /ID# 166845
      • Upland, California, United States, 91786
        • Inland Rheum Clin Trials Inc. /ID# 166621
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 166442
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606-1827
        • New England Research Associates, LLC /ID# 166525
      • New Haven, Connecticut, United States, 06510
        • Yale University /ID# 166330
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatic Disease Specialties /ID# 212582
      • Gainesville, Florida, United States, 32607-2817
        • SIMED Health, LLC /ID# 207457
      • Hialeah, Florida, United States, 33016-1897
        • Sweet Hope Research Specialty Inc /ID# 168163
      • Orlando, Florida, United States, 32806
        • Rheum Assoc of Central FL /ID# 201629
      • Orlando, Florida, United States, 32819
        • HMD Research LLC /ID# 208428
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research /ID# 201627
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center, Inc. /ID# 208116
      • Plantation, Florida, United States, 33324
        • IRIS Research and Development, LLC /ID# 166351
      • St. Petersburg, Florida, United States, 33705
        • BayCare Medical Group /ID# 201630
      • Tamarac, Florida, United States, 33321
        • West Broward Rheumatology Associates /ID# 201234
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 208467
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research /ID# 166375
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Arthritis and Rheumatology /ID# 169438
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681
      • Springfield, Illinois, United States, 62702-3749
        • Springfield Clinic /ID# 166345
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836-6455
        • Ochsner Clinic Foundation /ID# 166622
      • Monroe, Louisiana, United States, 71203
        • The Arthritis & Diabetes Clinic, Inc. /ID# 166707
    • Maine
      • Portland, Maine, United States, 04102
        • MMP Women's Health /ID# 169334
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Klein and Associates MD /ID# 166549
      • Wheaton, Maryland, United States, 20902
        • Duplicate_The Center for Rheumatology & Bone Research /ID# 166448
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Gr /ID# 166455
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology /ID# 166599
    • Missouri
      • Springfield, Missouri, United States, 65810-2607
        • Clinvest Research LLC /ID# 166745
      • St Louis, Missouri, United States, 63119-3845
        • Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Research Institute /ID# 169344
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /ID# 169443
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Ocean Rheumatology, PA /ID# 166561
      • Voorhees Township, New Jersey, United States, 08043
        • Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research Con /ID# 166334
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research of Oklahoma /ID# 166408
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Ctr Clinical Res /ID# 166691
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Ctr Reading /ID# 166354
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • West Tennessee Research Institute /ID# 166429
      • Nashville, Tennessee, United States, 37203
        • Nashville Arthritis and Rheumatology /ID# 208395
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Ctr for Clin Research /ID# 208340
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc. /ID# 166493
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions /ID# 208156
      • Houston, Texas, United States, 77065
        • Rheumatology Clinic of Houston /ID# 166636
      • Lubbock, Texas, United States, 79410-1198
        • West Texas Clinical Research /ID# 208155
      • Mesquite, Texas, United States, 75150
        • SW Rheumatology Res. LLC /ID# 166587
      • Plano, Texas, United States, 75024-5283
        • Trinity Universal Research Associates, Inc /ID# 208387
      • Tomball, Texas, United States, 77375
        • DM Clinical Research /ID# 208350
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Rheumatology /ID# 167667
      • Spokane, Washington, United States, 99204-2302
        • Arthritis Northwest, PLLC /ID# 169535
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology and Pulmonary Clinic /ID# 169341
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Rheumatic Disease Center, LLP /ID# 166682

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
  • Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
  • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.
  • Participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

Exclusion Criteria:

  • Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant has a known hypersensitivity to risankizumab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risankizumab
Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
Biological: Risankizumab
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI
Biological: Placebo
Placebo for risankizumab administered by subcutaneous (SC) injection
Placebo Comparator: Placebo
Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
Biological: Risankizumab
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI
Biological: Placebo
Placebo for risankizumab administered by subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Time Frame: Baseline and Week 24

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

  1. ≥ 20% improvement in 68-tender joint count;
  2. ≥ 20% improvement in 66-swollen joint count; and

  3. ≥ 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).
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an ACR20 Response at Week 16
Time Frame: Baseline and Week 16

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

  1. ≥ 20% improvement in 68-tender joint count;
  2. ≥ 20% improvement in 66-swollen joint count; and

  3. ≥ 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).
Baseline and Week 16
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Time Frame: 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 ≤ 15 (VAS from 0 to 100)
  • Patient's Global Assessment of disease activity ≤ 20 (VAS from 0 to 100)
  • 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, for an overall score range from 0 to 6)
Week 24
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
Time Frame: Baseline and Week 24

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

  1. ≥ 50% improvement in 68-tender joint count;
  2. ≥ 50% improvement in 66-swollen joint count; and

  3. ≥ 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).
Baseline and Week 24
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
Time Frame: Baseline and Week 24

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:

  1. ≥ 70% improvement in 68-tender joint count;
  2. ≥ 70% improvement in 66-swollen joint count; and

  3. ≥ 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).
Baseline and Week 24
Percentage of Participants With Resolution of Enthesitis at Week 24
Time Frame: Week 24

Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.

LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).
Week 24
Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
Time Frame: Baseline and Week 24

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.
Baseline and Week 24
Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
Time Frame: Baseline and Week 24

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 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score.
Baseline and Week 24
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Time Frame: Baseline and Week 24

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 summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement.
Baseline and Week 24
Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
Time Frame: Baseline and Week 24
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 score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
Baseline and Week 24
Percentage of Participants With Resolution of Dactylitis at Week 24
Time Frame: Week 24

Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.

The LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used.

Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2019

Primary Completion (Actual)

June 22, 2020

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-998
  • 2023-505477-33 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

For details on when studies are available for sharing, please refer to the link below.

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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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