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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)

Primary Purpose

Psoriatic Arthritis (PsA)

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Risankizumab

About this trial

This is an interventional treatment trial for Psoriatic Arthritis (PsA) focused on measuring KEEPsAKE 2, Risankizumab

Eligibility Criteria

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

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.

Sites / Locations

Pinnacle Research Group /ID# 167953
St. Jude Heritage /ID# 166842
Newport Huntington Medica /ID# 207423
Arthritis & Osteo Medical Ctr /ID# 166541
East Bay Rheumatology Medical /ID# 166845
Inland Rheum Clin Trials Inc. /ID# 166621
Denver Arthritis Clinic /ID# 166442
New England Research Associates, LLC /ID# 166525
Yale University /ID# 166330
Arthritis & Rheumatic Disease Specialties /ID# 212582
SIMED Health, LLC /ID# 207457
Sweet Hope Research Specialty Inc /ID# 168163
Rheum Assoc of Central FL /ID# 201629
HMD Research LLC /ID# 208428
Millennium Research /ID# 201627
Arthritis Center, Inc. /ID# 208116
IRIS Research and Development, LLC /ID# 166351
BayCare Medical Group /ID# 201630
West Broward Rheumatology Associates /ID# 201234
University of South Florida /ID# 208467
ForCare Clinical Research /ID# 166375
Arthritis and Rheumatology /ID# 169438
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681
Springfield Clinic /ID# 166345
Ochsner Clinic Foundation /ID# 166622
The Arthritis & Diabetes Clinic, Inc. /ID# 166707
MMP Women's Health /ID# 169334
Klein and Associates MD /ID# 166549
Duplicate_The Center for Rheumatology & Bone Research /ID# 166448
Clinical Pharmacology Study Gr /ID# 166455
St. Paul Rheumatology /ID# 166599
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389
Clinvest Research LLC /ID# 166745
Glacier View Research Institute /ID# 169344
Dartmouth-Hitchcock Medical Center /ID# 169443
Ocean Rheumatology, PA /ID# 166561
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658
Paramount Medical Research Con /ID# 166334
Health Research of Oklahoma /ID# 166408
Altoona Ctr Clinical Res /ID# 166691
Clinical Research Ctr Reading /ID# 166354
West Tennessee Research Institute /ID# 166429
Nashville Arthritis and Rheumatology /ID# 208395
Amarillo Ctr for Clin Research /ID# 208340
Tekton Research, Inc. /ID# 166493
Precision Comprehensive Clinical Research Solutions /ID# 208156
Rheumatology Clinic of Houston /ID# 166636
West Texas Clinical Research /ID# 208155
SW Rheumatology Res. LLC /ID# 166587
Trinity Universal Research Associates, Inc /ID# 208387
DM Clinical Research /ID# 208350
Kadlec Clinic Rheumatology /ID# 167667
Arthritis Northwest, PLLC /ID# 169535
Rheumatology and Pulmonary Clinic /ID# 169341
Rheumatic Disease Center, LLP /ID# 166682
Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
Hospital Italiano de Buenos Aires /ID# 208473
DOM Centro de Reumatologia /ID# 208478
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151
Instituto CAICI /ID# 169156
Centro Medico Privado de Reumatologia /ID# 208342
Cimer /Id# 169155
The Canberra Hospital /ID# 207591
Rheumatology Research Unit Sunshine Coast /ID# 207191
Griffith University /ID# 207504
Emeritus Research /ID# 207195
Monash Medical Centre /ID# 208033
UZ Gent /ID# 210037
Universitair Ziekenhuis Leuven /ID# 208209
ReumaClinic /ID# 208211
ZNA - Jan Palfijn /ID# 208210
CIP - Centro Internacional de Pesquisa /ID# 169524
LMK Sevicos Medicos S/S /ID# 169541
Percuro Clinical Research, Ltd /ID# 169530
CIADS Research Co Ltd /ID# 169526
Dermatrials Research /ID# 208303
K. Papp Clinical Research /ID# 169527
Centre Rhumatologie de l'Est /ID# 208302
Bispebjerg and Frederiksberg Hospital /ID# 168763
Aarhus University Hospital /ID# 168762
East Tallinn Central Hospital /ID# 208317
MediTrials /ID# 207815
North Estonia Medical Centre /ID# 208319
Ite Pihlajanlinna Kuopio /ID# 208316
Turku University Hospital /ID# 208199
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
CHRU Tours - Hopital Trousseau /ID# 209343
Rheumazentrum Ruhrgebiet /ID# 207212
Immanuel Krankenhaus Berlin /ID# 207214
Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493
University General Hospital of Heraklion PA.G.N.I /ID# 206930
Naval Hospital of Athens /ID# 206928
Olympion General Clinic SA /ID# 207047
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237
Vital-Medicina Kft. /ID# 208123
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054
Sheba Medical Center /ID# 207468
Barzilai Medical Center /ID# 207471
Rambam Health Care Campus /ID# 208169
Meir Medical Center /ID# 207469
Rabin Medical Center /ID# 207470
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268
Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264
Antonius Ziekenhuis /ID# 208581
Universitair Medisch Centrum Groningen /ID# 168450
Medisch Centrum Leeuwarden /ID# 168449
Waikato Hospital /ID# 214276
Middlemore Clinical Trials /ID# 214293
CGM Research Trust /ID# 210596
Malopolskie Centrum Kliniczne /ID# 208011
Centrum Medyczne Reuma Park w Warszawie /ID# 210956
Osteo-Medic S.C. /ID# 208013
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012
Centrum Kliniczno-Badawcze /ID# 208014
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138
Instituto Português De Reumatologia /ID# 208140
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139
GCM Medical Group PSC - Hato Rey /ID# 208461
Changi General Hospital /ID# 208966
Dr Jenny Potts /ID# 167628
Arthritis Clinical Research Trials /ID# 167611
Winelands Medical Research Centre /ID# 167630
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
Hospital Unversitario Marques de Valdecilla /ID# 208541
Hospital Universitario A Coruna - CHUAC /ID# 207819
Hospital Universitario 12 de Octubre /ID# 207820
Hospital Universitario y Politecnico La Fe /ID# 207823
Orebro Universitetssjukhuset /ID# 169400
Duplicate_Karolinska Univ Sjukhuset /ID# 208174
Uppsala University Hospital /ID# 169098
Duplicate_Vastmanlands Sjukhus /ID# 168620
Duplicate_Barts Health NHS Trust /ID# 210794
Manchester University NHS Foundation Trust /ID# 207923
Torbay and South Devon Nhs Foundation Trust /Id# 207926
Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Risankizumab

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

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 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.

Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at 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.

Percentage of Participants With an ACR20 Response at Week 16

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 ≤ 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)

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at 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.

Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at 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.

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24

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 24

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 Resolution of Enthesitis at 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).

Percentage of Participants With Resolution of Dactylitis at 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.

Full Information

NCT ID

NCT03671148

First Posted

September 12, 2018

Last Updated

April 14, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03671148

Brief Title

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)

Acronym

KEEPsAKE2

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 7, 2019 (Actual)

Primary Completion Date

June 22, 2020 (Actual)

Study Completion Date

June 12, 2026 (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 purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

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.

6. Conditions and Keywords

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

Psoriatic Arthritis (PsA)

Keywords

KEEPsAKE 2, Risankizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

444 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Risankizumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo for risankizumab administered by subcutaneous (SC) injection

Intervention Type

Biological

Intervention Name(s)

Risankizumab

Other Intervention Name(s)

ABBV-066, BI 655066, SKYRIZI

Intervention Description

Risankizumab administered by subcutaneous (SC) injection

Primary Outcome Measure Information:

Title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

Description

Time Frame

Baseline and Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With an ACR20 Response at Week 16

Description

Time Frame

Baseline and Week 16

Title

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

Description

Time Frame

Week 24

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With Resolution of Enthesitis at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants With Resolution of Dactylitis at Week 24

Description

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ABBVIE INC.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Pinnacle Research Group /ID# 167953

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

St. Jude Heritage /ID# 166842

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Newport Huntington Medica /ID# 207423

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648-5994

Country

United States

Facility Name

Arthritis & Osteo Medical Ctr /ID# 166541

City

La Palma

State/Province

California

ZIP/Postal Code

90623-1728

Country

United States

Facility Name

East Bay Rheumatology Medical /ID# 166845

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

Inland Rheum Clin Trials Inc. /ID# 166621

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Denver Arthritis Clinic /ID# 166442

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

New England Research Associates, LLC /ID# 166525

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606-1827

Country

United States

Facility Name

Yale University /ID# 166330

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Arthritis & Rheumatic Disease Specialties /ID# 212582

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

SIMED Health, LLC /ID# 207457

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607-2817

Country

United States

Facility Name

Sweet Hope Research Specialty Inc /ID# 168163

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016-1897

Country

United States

Facility Name

Rheum Assoc of Central FL /ID# 201629

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

HMD Research LLC /ID# 208428

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Millennium Research /ID# 201627

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Arthritis Center, Inc. /ID# 208116

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

IRIS Research and Development, LLC /ID# 166351

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

BayCare Medical Group /ID# 201630

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

West Broward Rheumatology Associates /ID# 201234

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

University of South Florida /ID# 208467

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

ForCare Clinical Research /ID# 166375

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613-1244

Country

United States

Facility Name

Arthritis and Rheumatology /ID# 169438

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

Facility Name

Springfield Clinic /ID# 166345

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702-3749

Country

United States

Facility Name

Ochsner Clinic Foundation /ID# 166622

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70836-6455

Country

United States

Facility Name

The Arthritis & Diabetes Clinic, Inc. /ID# 166707

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

MMP Women's Health /ID# 169334

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

Klein and Associates MD /ID# 166549

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Duplicate_The Center for Rheumatology & Bone Research /ID# 166448

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Clinical Pharmacology Study Gr /ID# 166455

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

St. Paul Rheumatology /ID# 166599

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55121

Country

United States

Facility Name

Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63119-3845

Country

United States

Facility Name

Clinvest Research LLC /ID# 166745

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65810-2607

Country

United States

Facility Name

Glacier View Research Institute /ID# 169344

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center /ID# 169443

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Ocean Rheumatology, PA /ID# 166561

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Paramount Medical Research Con /ID# 166334

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Health Research of Oklahoma /ID# 166408

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103-2400

Country

United States

Facility Name

Altoona Ctr Clinical Res /ID# 166691

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Clinical Research Ctr Reading /ID# 166354

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

West Tennessee Research Institute /ID# 166429

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Nashville Arthritis and Rheumatology /ID# 208395

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Amarillo Ctr for Clin Research /ID# 208340

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

Tekton Research, Inc. /ID# 166493

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Precision Comprehensive Clinical Research Solutions /ID# 208156

City

Colleyville

State/Province

Texas

ZIP/Postal Code

76034

Country

United States

Facility Name

Rheumatology Clinic of Houston /ID# 166636

City

Houston

State/Province

Texas

ZIP/Postal Code

77065

Country

United States

Facility Name

West Texas Clinical Research /ID# 208155

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410-1198

Country

United States

Facility Name

SW Rheumatology Res. LLC /ID# 166587

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Trinity Universal Research Associates, Inc /ID# 208387

City

Plano

State/Province

Texas

ZIP/Postal Code

75024-5283

Country

United States

Facility Name

DM Clinical Research /ID# 208350

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Kadlec Clinic Rheumatology /ID# 167667

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

Arthritis Northwest, PLLC /ID# 169535

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204-2302

Country

United States

Facility Name

Rheumatology and Pulmonary Clinic /ID# 169341

City

Beckley

State/Province

West Virginia

ZIP/Postal Code

25801

Country

United States

Facility Name

Rheumatic Disease Center, LLP /ID# 166682

City

Glendale

State/Province

Wisconsin

ZIP/Postal Code

53217

Country

United States

Facility Name

Hospital General de Agudos J. M. Ramos Mejia /ID# 169152

City

Buenos Aires

State/Province

Ciuadad Autonoma De Buenos Aires

ZIP/Postal Code

1221

Country

Argentina

Facility Name

Hospital Italiano de Buenos Aires /ID# 208473

City

Ciudad Autonoma Buenos Aires

State/Province

Ciuadad Autonoma De Buenos Aires

ZIP/Postal Code

1199

Country

Argentina

Facility Name

DOM Centro de Reumatologia /ID# 208478

City

Ciudad Autonoma de Buenos Aire

State/Province

Ciuadad Autonoma De Buenos Aires

ZIP/Postal Code

1111

Country

Argentina

Facility Name

Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Instituto CAICI /ID# 169156

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Centro Medico Privado de Reumatologia /ID# 208342

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Cimer /Id# 169155

City

San Miguel de Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

The Canberra Hospital /ID# 207591

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2605

Country

Australia

Facility Name

Rheumatology Research Unit Sunshine Coast /ID# 207191

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Griffith University /ID# 207504

City

Southport

State/Province

Queensland

ZIP/Postal Code

4222

Country

Australia

Facility Name

Emeritus Research /ID# 207195

City

Camberwell

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

Facility Name

Monash Medical Centre /ID# 208033

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

UZ Gent /ID# 210037

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Universitair Ziekenhuis Leuven /ID# 208209

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

Facility Name

ReumaClinic /ID# 208211

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

ZNA - Jan Palfijn /ID# 208210

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

CIP - Centro Internacional de Pesquisa /ID# 169524

City

Goiânia

State/Province

Goias

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

LMK Sevicos Medicos S/S /ID# 169541

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90480-000

Country

Brazil

Facility Name

Percuro Clinical Research, Ltd /ID# 169530

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3M9

Country

Canada

Facility Name

CIADS Research Co Ltd /ID# 169526

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3N 0K6

Country

Canada

Facility Name

Dermatrials Research /ID# 208303

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

K. Papp Clinical Research /ID# 169527

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Centre Rhumatologie de l'Est /ID# 208302

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 8W1

Country

Canada

Facility Name

Bispebjerg and Frederiksberg Hospital /ID# 168763

City

Frederiksberg

State/Province

Hovedstaden

ZIP/Postal Code

2000

Country

Denmark

Facility Name

Aarhus University Hospital /ID# 168762

City

Aarhus C

State/Province

Midtjylland

ZIP/Postal Code

8000

Country

Denmark

Facility Name

East Tallinn Central Hospital /ID# 208317

City

Tallinn

State/Province

Harjumaa

ZIP/Postal Code

10138

Country

Estonia

Facility Name

MediTrials /ID# 207815

City

Tartu

State/Province

Tartumaa

ZIP/Postal Code

50708

Country

Estonia

Facility Name

North Estonia Medical Centre /ID# 208319

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Ite Pihlajanlinna Kuopio /ID# 208316

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

Turku University Hospital /ID# 208199

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

CHRU Tours - Hopital Trousseau /ID# 209343

City

Chambray Les Tours

ZIP/Postal Code

37170

Country

France

Facility Name

Rheumazentrum Ruhrgebiet /ID# 207212

City

Herne

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44649

Country

Germany

Facility Name

Immanuel Krankenhaus Berlin /ID# 207214

City

Berlin-buch

ZIP/Postal Code

13125

Country

Germany

Facility Name

Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

University General Hospital of Heraklion PA.G.N.I /ID# 206930

City

Heraklion

State/Province

Kriti

ZIP/Postal Code

71307

Country

Greece

Facility Name

Naval Hospital of Athens /ID# 206928

City

Athens

ZIP/Postal Code

11521

Country

Greece

Facility Name

Olympion General Clinic SA /ID# 207047

City

Patras

ZIP/Postal Code

26443

Country

Greece

Facility Name

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248

City

Miskolc

State/Province

Borsod-Abauj-Zemplen

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237

City

Szeged

State/Province

Csongrad

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Vital-Medicina Kft. /ID# 208123

City

Veszprém

State/Province

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Sheba Medical Center /ID# 207468

City

Ramat Gan

State/Province

Tel-Aviv

ZIP/Postal Code

5239424

Country

Israel

Facility Name

Barzilai Medical Center /ID# 207471

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Rambam Health Care Campus /ID# 208169

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Meir Medical Center /ID# 207469

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Rabin Medical Center /ID# 207470

City

Petakh Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41124

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Antonius Ziekenhuis /ID# 208581

City

Sneek

State/Province

Fryslan

ZIP/Postal Code

8601 ZK

Country

Netherlands

Facility Name

Universitair Medisch Centrum Groningen /ID# 168450

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Medisch Centrum Leeuwarden /ID# 168449

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Waikato Hospital /ID# 214276

City

Hamilton

State/Province

Waikato

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Middlemore Clinical Trials /ID# 214293

City

Auckland

ZIP/Postal Code

2025

Country

New Zealand

Facility Name

CGM Research Trust /ID# 210596

City

Burwood Christchurch

ZIP/Postal Code

8083

Country

New Zealand

Facility Name

Malopolskie Centrum Kliniczne /ID# 208011

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

30-149

Country

Poland

Facility Name

Centrum Medyczne Reuma Park w Warszawie /ID# 210956

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Osteo-Medic S.C. /ID# 208013

City

Bialystok

State/Province

Podlaskie

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012

City

Gdansk

State/Province

Pomorskie

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Centrum Kliniczno-Badawcze /ID# 208014

City

Elblag

State/Province

Warminsko-mazurskie

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138

City

Ponte de Lima

State/Province

Viana Do Castelo

ZIP/Postal Code

4990-041

Country

Portugal

Facility Name

Instituto Português De Reumatologia /ID# 208140

City

Lisboa

ZIP/Postal Code

1050-034

Country

Portugal

Facility Name

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

GCM Medical Group PSC - Hato Rey /ID# 208461

City

San Juan

ZIP/Postal Code

00917-3104

Country

Puerto Rico

Facility Name

Changi General Hospital /ID# 208966

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

Facility Name

Dr Jenny Potts /ID# 167628

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6405

Country

South Africa

Facility Name

Arthritis Clinical Research Trials /ID# 167611

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Winelands Medical Research Centre /ID# 167630

City

Stellenbosch

State/Province

Western Cape

ZIP/Postal Code

7600

Country

South Africa

Facility Name

Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Unversitario Marques de Valdecilla /ID# 208541

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Universitario A Coruna - CHUAC /ID# 207819

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre /ID# 207820

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario y Politecnico La Fe /ID# 207823

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Orebro Universitetssjukhuset /ID# 169400

City

Orebro

State/Province

Orebro Lan

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Duplicate_Karolinska Univ Sjukhuset /ID# 208174

City

Solna

ZIP/Postal Code

171 64

Country

Sweden

Facility Name

Uppsala University Hospital /ID# 169098

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Duplicate_Vastmanlands Sjukhus /ID# 168620

City

Vasteras

ZIP/Postal Code

723 35

Country

Sweden

Facility Name

Duplicate_Barts Health NHS Trust /ID# 210794

City

London

State/Province

London, City Of

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Manchester University NHS Foundation Trust /ID# 207923

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Torbay and South Devon Nhs Foundation Trust /Id# 207926

City

Torquay

ZIP/Postal Code

TQ2 7AA

Country

United Kingdom

Facility Name

Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536

City

Wirral

ZIP/Postal Code

CH49 5PE

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

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 URL

https://vivli.org/ourmember/abbvie/

Citations:

PubMed Identifier

34815219

Citation

Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Alperovich G, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022 Mar;81(3):351-358. doi: 10.1136/annrheumdis-2021-221048. Epub 2021 Nov 23.

Results Reference

result

PubMed Identifier

36282537

Citation

Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Lu W, Wang Z, Soliman AM, Eldred A, Padilla B, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2122-2129. doi: 10.1093/rheumatology/keac605.

Results Reference

derived

PubMed Identifier

36178584

Citation

Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.

Results Reference

derived

PubMed Identifier

35701011

Citation

Ostor AJK, Soliman AM, Papp KA, Padilla B, Wang Z, Eldred A, de Vlam K, Kivitz A. Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. RMD Open. 2022 Jun;8(2):e002286. doi: 10.1136/rmdopen-2022-002286.

Results Reference

derived

Links:

URL

https://www.abbvieclinicaltrials.com/study/?id=M15-998

Description

Related Info

Learn more about this trial

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)

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