Back to resultsA Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
Primary Purpose
Psoriatic Arthritis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Risankizumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
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) at the Screening Visit.
- Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts)
- 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 or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
Presence of either at Screening:
- ≥ 1 erosion on radiograph as determined by central imaging review or;
- High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.
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.
- Participant has previous treatment with biologic agent.
Sites / Locations
- Pinnacle Research Group /ID# 167955
- Sun Valley Arthritis Center Ltd. /ID# 200270
- AZ Arthritis and Rheumotology Research, PLLC /ID# 209873
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875
- Southern Arizona VA Health Care System /ID# 209247
- Arthritis and Rheumatism Associates /ID# 209882
- Valerius Medical Group & Research Center /ID# 207428
- Rheumatology Center of San Diego /ID# 201642
- Inland Rheum Clin Trials Inc. /ID# 201641
- Medvin Clinical Research /ID# 211127
- New England Research Associates, LLC /ID# 207237
- Danbury Clinical Research, LLC /ID# 209517
- Arthritis & Osteoporosis Center /ID# 207236
- Arthritis & Rheumatic Disease Specialties /ID# 210802
- Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099
- SIMED Health, LLC /ID# 207461
- Sweet Hope Research Specialty Inc /ID# 209393
- Jacksonville Center for Clinical Research /ID# 209876
- Rheum Assoc of Central FL /ID# 201622
- HMD Research LLC /ID# 208427
- IRIS Research and Development, LLC /ID# 208955
- ForCare Clinical Research /ID# 168034
- Arthritis and Rheumatology /ID# 168046
- Affinity Clinical Research /ID# 210816
- OrthoIllinois /ID# 205300
- Springfield Clinic /ID# 200244
- Klein and Associates MD /ID# 169483
- The Center for Rheumatology and Bone Research /ID# 168017
- Clinical Pharmacology Study Gr /ID# 168019
- Advanced Rheumatology, PC /ID# 168042
- June DO, PC /ID# 208915
- St. Paul Rheumatology /ID# 208471
- Logan Health Research /ID# 213707
- Physician Research Collaboration, LLC /ID# 208670
- Center for Rheumatology LLP /ID# 207313
- NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310
- Joint & Muscle Research Instit /ID# 208620
- Medication Management, LLC /ID# 211734
- Coastal Carolina Health Care /ID# 208619
- Velocity Clinical Research /ID# 200452
- Marietta Memorial Hospital /ID# 210179
- Paramount Medical Research Con /ID# 201583
- STAT Research, Inc. /ID# 213805
- Health Research of Oklahoma /ID# 168027
- Altoona Ctr Clinical Res /ID# 168037
- Allegheny Health Network Research Institute /ID# 210349
- Clinical Research Ctr Reading /ID# 168070
- Nashville Arthritis and Rheumatology /ID# 168069
- Amarillo Ctr for Clin Research /ID# 208347
- Precision Comprehensive Clinical Research Solutions /ID# 208386
- Dallas VA Medical Center /ID# 208389
- Precision Comprehensive Clinical Research Solutions /ID# 210597
- Advanced Rheumatology of Houston /ID# 208354
- DM Clinical Research /ID# 208351
- Kadlec Clinic Rheumatology /ID# 207969
- Rheumatology and Pulmonary Clinic /ID# 200446
- Aurora Rheumatology and Immunotherapy Center /ID# 168066
- Holy Family Memorial, Inc. /ID# 209387
- Gundersen Clinic, Ltd /ID# 209459
- Framingham Centro Medico /ID# 210409
- Hospital General de Agudos J. M. Ramos Mejia /ID# 169164
- Hospital Italiano de Buenos Aires /ID# 208474
- DOM Centro de Reumatologia /ID# 208479
- Fundacion CIDEA /ID# 210494
- Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 211622
- Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169163
- Instituto CAICI /ID# 169168
- Centro Medico Privado de Reumatologia /ID# 208343
- Duplicate_Inst de Rehab Psicofisica /ID# 214681
- Duplicate_Hospital Privado Univesitario /ID# 211623
- Cimer /Id# 169167
- The Canberra Hospital /ID# 207592
- Royal Brisbane and Women's Hospital /ID# 212785
- Rheumatology Research Unit Sunshine Coast /ID# 207200
- Griffith University /ID# 207505
- Flinders Medical Centre /ID# 210562
- Emeritus Research /ID# 207202
- Monash Medical Centre /ID# 208034
- Duplicate_UZ Ghent /ID# 210036
- ReumaClinic /ID# 208213
- ZNA - Jan Palfijn /ID# 208212
- University Clinical Centre of the Republic of Srpska /ID# 208268
- University Clinical Centre of the Republic of Srpska /ID# 208269
- University Clinical Centre of the Republic of Srpska /ID# 210047
- Clinical Center University of Sarajevo /ID# 208272
- SER - Serviços Especializados em Reumatologia /ID# 207489
- CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496
- EDUMED Educacao em Saude S/S L /ID# 207488
- LMK Sevicos Medicos S/S /ID# 207491
- CPCLIN - Centro de Pesquisas Clínicas /ID# 207493
- Medical center Medconsult /ID# 211399
- Medical center Excelsior /ID# 167741
- Diagnostic consultative center 17 Sofia /ID# 210506
- Military Medical Academy Multiprofile Hospital /ID# 210829
- Percuro Clinical Research, Ltd /ID# 169601
- Manitoba Clinic /ID# 206819
- CIADS Research Co Ltd /ID# 169600
- SKIN Centre for Dermatology /ID# 169604
- K. Papp Clinical Research /ID# 169603
- Groupe de Recherche en Maladies Osseuses Inc /ID# 169598
- Dr. Latha Naik /ID# 212188
- CTR Estudios Clinicos /ID# 208166
- Centro Internacional de Estudios Clinicos /ID# 209908
- Clinica Dermacross S.A /ID# 208163
- Poliklinika Repromed /ID# 208628
- Poliklinika Solmed /ID# 210965
- UHC Osijek /ID# 208623
- Klinicki bolnicki centar Rijeka /ID# 208621
- Klinicki bolnicki centar Split /ID# 208626
- Medical Center Kuna-Peric /ID# 208047
- Poliklinika Bonifarm /ID# 208750
- Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025
- PV MEDICAL Services s.r.o. /ID# 210222
- MUDr. Zuzana Stejfova - revmatologicka ambulance /ID# 209027
- Affidea Praha s.r.o. /ID# 210223
- MEDICAL PLUS, s.r.o. /ID# 210439
- Bispebjerg and Frederiksberg Hospital /ID# 207576
- Aarhus University Hospital /ID# 168761
- North Estonia Medical Centre /ID# 208325
- Innomedica /ID# 211416
- MediTrials /ID# 207816
- Helsinki University Hospital /ID# 207724
- Ite Pihlajanlinna Kuopio /ID# 208322
- Turku University Hospital /ID# 207726
- Rheumazentrum Ruhrgebiet /ID# 207216
- Immanuel Krankenhaus Berlin /ID# 207218
- Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209483
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209484
- General Hospital Asklepieio Voulas /ID# 212956
- University General Hospital of Heraklion PA.G.N.I /ID# 206839
- 424 General MILITARY Hospital /ID# 210974
- Naval Hospital of Athens /ID# 206838
- Olympion General Clinic SA /ID# 207048
- Sheba Medical Center /ID# 207474
- Barzilai Medical Center /ID# 207476
- Rambam Health Care Campus /ID# 208170
- Meir Medical Center /ID# 207473
- Rabin Medical Center /ID# 207475
- Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207269
- A.O.U. Policlinico G. Rodolico S.Marco - Presidio San Marco /ID# 207795
- Duplicate_Policlinico Univ Tor Vergata /ID# 207271
- Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207265
- Hanyang University Seoul Hospital /ID# 209263
- Duplicate_Konkuk University Medical Ctr /ID# 207509
- Kyungpook National Univ Hosp /ID# 207408
- M & M Centrs LTD /ID# 208733
- D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 207224
- Pauls Stradins Clinical University Hospital /ID# 207220
- Clinic ORTO /ID# 216218
- Riga East Clinical University Hospital /ID# 207223
- VAKK Dr. Kilda's Clinic /ID# 207330
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207331
- Klaipeda University Hospital /ID# 207329
- Republican Siauliai hospital /ID# 207328
- Hospital Tuanku Jaafar /ID# 207919
- Hospital Raja Permaisuri Bainun /ID# 207920
- Hospital Selayang /ID# 208938
- University Malaya Med Ctr /ID# 208937
- CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331
- Centro Integral en Reumatologia S.A de C.V /ID# 208346
- Eukarya PharmaSite, SC /ID# 208431
- Centro Peninsular de Investigación Clínica SCP /ID# 208345
- Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835
- RM Pharma Specialists S.A de C.V /ID# 208330
- Antonius Ziekenhuis /ID# 208587
- Universitair Medisch Centrum Groningen /ID# 208580
- Medisch Centrum Leeuwarden /ID# 168453
- Middlemore Clinical Trials /ID# 213256
- Waikato Hospital /ID# 213257
- CGM Research Trust /ID# 210498
- Spolka Lekarzy INTERCOR /ID# 210191
- Nasz Lekarz Przychodnie Medyczne /ID# 216176
- Malopolskie Centrum Kliniczne /ID# 208007
- McBk Sc /Id# 209132
- Centrum Medyczne Reuma Park w Warszawie /ID# 210352
- Osteo-Medic S.C. /ID# 208008
- ClinicMed Daniluk, Nowak Sp.j. /ID# 210824
- Centrum Kliniczno-Badawcze /ID# 208010
- ETYKA-Osrodek Badan Klinicznych /ID# 216241
- Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208145
- Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208147
- Centro Hospitalar do Baixo Vouga /ID# 215979
- CCA Braga - Hospital de Braga /ID# 208146
- Instituto Português De Reumatologia /ID# 208149
- Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208148
- Mindful Medical Research /ID# 211129
- Cabinet Medical Dr Triff Carina /Id# 207528
- Spitalul Clinic Sf. Maria /ID# 210054
- Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 207340
- Spitalul Clinic de Recuperare Iasi /ID# 207371
- LLC Family Outpatient Clinic № /ID# 169510
- Research Institute of Rheumatology named after V.A. Nasonova /ID# 207643
- LLC Medical Center /ID# 169516
- Nort-Western State Medical University n.a. Mechnikov /ID# 207641
- Kazan State Medical University /ID# 169511
- Federal Center for Brain and Neurotechnology /ID# 207646
- Perm Regional Clinical Hospital /ID# 207642
- Ulyanovsk Regional Clinical Hospital /ID# 169515
- Institute for Rheumatology /ID# 168194
- Institute for Rheumatology /ID# 168197
- Institute for Rheumatology /ID# 168198
- Institute for Rheumatology /ID# 168199
- Military Medical Academy /ID# 168218
- Special Hospital for Rheuma /ID# 168255
- Special Hospital for Rheuma /ID# 210284
- National University Hospital /ID# 208599
- Singapore General Hospital /ID# 207917
- Changi General Hospital /ID# 208965
- REUMA-GLOBAL, s.r.o. /ID# 208017
- MEDMAN s.r.o. /ID# 208018
- Reum.hapi s.r.o. /ID# 208016
- Thermium s.r.o. /ID# 208015
- REUMAMED POPRAD s.r.o. /ID# 208407
- Dr Jenny Potts /ID# 168691
- University of Pretoria /ID# 167621
- Dr Elsa van Duuren /ID# 207577
- Arthritis Clinical Research Trials /ID# 167625
- Synexus Helderberg Clinical Research Centre /ID# 210891
- Winelands Medical Research Centre /ID# 167629
- Hospital Universitario Germans Trias i Pujol /ID# 208543
- Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207830
- Hospital Universitario A Coruna - CHUAC /ID# 207826
- Hospital Universitario Torrecardenas /ID# 212716
- Hospital Parc de Salut del Mar /ID# 209698
- Hospital Clinico Universitario San Carlos /ID# 207832
- Hospital Universitario 12 de Octubre /ID# 207827
- Hospital Universitario y Politecnico La Fe /ID# 207831
- Orebro Universitetssjukhuset /ID# 207948
- Skane University hospital /ID# 210070
- Falu Lasarett /ID# 210322
- Duplicate_Karolinska Univ Sjukhuset /ID# 208175
- Uppsala University Hospital /ID# 207944
- Duplicate_Vastmanlands Sjukhus /ID# 207943
- Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567
- Chung Shan Medical University Hospital /ID# 207257
- Linkou Chang Gung Memorial Ho /ID# 207255
- State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556
- Scientific Research Institute of Invalid Rehabilitation /ID# 207873
- CNE Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912
- MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 207730
- PNE City Multifunctional Hospital No.18 /ID# 207911
- Khmelnytskyi Regional Hospital /ID# 207753
- MI Kryvyi Rih City Clinical Hospital No.2 /ID# 207748
- Medical Center OK Clinic /ID# 207749
- Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 208276
- Lviv Municipal City Clinical Hospital #4 /ID# 207715
- PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 207872
- Public Institution 6th City Clinical Hospital /ID# 207754
- Duplicate_Barts Health NHS Trust /ID# 210534
- NHS Greater Glasgow and Clyde /ID# 214942
- Midlands Partnership NHS Foundation Trust /ID# 214941
- Manchester University NHS Foundation Trust /ID# 207928
- Portsmouth Hospitals University NHS Trust /ID# 207932
- Torbay and South Devon Nhs Foundation Trust /Id# 207931
- Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210535
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Risankizumab
Arm Description
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.
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.
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
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).
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 Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula.
The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline indicates improvement.
Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)
The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative change from Baseline indicates improvement.
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).
To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
Percentage of Participants With Resolution of Dactylitis at Week 24
Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.
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.
To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24
The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.
Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).
Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).
Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.
The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03675308
Brief Title
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Acronym
KEEPsAKE 1
Official Title
A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
September 28, 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
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants 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 treatment period. Period 2 is the long-term treatment 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 are to receive open-label risankizumab 150 mg every 12 weeks. Participants will 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
964 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Risankizumab
Arm Type
Experimental
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo for risankizumab administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066, SKYRIZI
Intervention Description
Risankizumab administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Description
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).
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
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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants With an ACR20 Response at Week 16
Description
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).
Time Frame
Baseline and Week 16
Title
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Description
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)
Time Frame
Week 24
Title
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
Description
The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula.
The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)
Description
The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 24
Title
Percentage of Participants With Resolution of Enthesitis at Week 24
Description
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).
To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
Time Frame
Week 24
Title
Percentage of Participants With Resolution of Dactylitis at Week 24
Description
Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.
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.
To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
Time Frame
Week 24
Title
Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24
Description
The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.
Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).
Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).
Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.
The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst).
Time Frame
Baseline and Week 24
Title
Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Description
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.
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
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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
Description
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).
Time Frame
Baseline and Week 24
Title
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
Description
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).
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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) at the Screening Visit.
Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts)
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 or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
Presence of either at Screening:
≥ 1 erosion on radiograph as determined by central imaging review or;
High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.
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.
Participant has previous treatment with biologic agent.
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# 167955
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Sun Valley Arthritis Center Ltd. /ID# 200270
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 209873
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Southern Arizona VA Health Care System /ID# 209247
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Arthritis and Rheumatism Associates /ID# 209882
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401-6251
Country
United States
Facility Name
Valerius Medical Group & Research Center /ID# 207428
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5402
Country
United States
Facility Name
Rheumatology Center of San Diego /ID# 201642
City
San Diego
State/Province
California
ZIP/Postal Code
92128-2549
Country
United States
Facility Name
Inland Rheum Clin Trials Inc. /ID# 201641
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Medvin Clinical Research /ID# 211127
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
New England Research Associates, LLC /ID# 207237
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606-1827
Country
United States
Facility Name
Danbury Clinical Research, LLC /ID# 209517
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Arthritis & Osteoporosis Center /ID# 207236
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties /ID# 210802
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
SIMED Health, LLC /ID# 207461
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607-2817
Country
United States
Facility Name
Sweet Hope Research Specialty Inc /ID# 209393
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1897
Country
United States
Facility Name
Jacksonville Center for Clinical Research /ID# 209876
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Rheum Assoc of Central FL /ID# 201622
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
HMD Research LLC /ID# 208427
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
IRIS Research and Development, LLC /ID# 208955
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
ForCare Clinical Research /ID# 168034
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Arthritis and Rheumatology /ID# 168046
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Affinity Clinical Research /ID# 210816
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523-1245
Country
United States
Facility Name
OrthoIllinois /ID# 205300
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114-4937
Country
United States
Facility Name
Springfield Clinic /ID# 200244
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-3749
Country
United States
Facility Name
Klein and Associates MD /ID# 169483
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
The Center for Rheumatology and Bone Research /ID# 168017
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Clinical Pharmacology Study Gr /ID# 168019
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Advanced Rheumatology, PC /ID# 168042
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
June DO, PC /ID# 208915
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
St. Paul Rheumatology /ID# 208471
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Logan Health Research /ID# 213707
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Physician Research Collaboration, LLC /ID# 208670
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Center for Rheumatology LLP /ID# 207313
City
Albany
State/Province
New York
ZIP/Postal Code
12203-3710
Country
United States
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Joint & Muscle Research Instit /ID# 208620
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Medication Management, LLC /ID# 211734
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Coastal Carolina Health Care /ID# 208619
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Velocity Clinical Research /ID# 200452
City
Blue Ash
State/Province
Ohio
ZIP/Postal Code
45242-3763
Country
United States
Facility Name
Marietta Memorial Hospital /ID# 210179
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750-1635
Country
United States
Facility Name
Paramount Medical Research Con /ID# 201583
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
STAT Research, Inc. /ID# 213805
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Health Research of Oklahoma /ID# 168027
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2400
Country
United States
Facility Name
Altoona Ctr Clinical Res /ID# 168037
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Allegheny Health Network Research Institute /ID# 210349
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4756
Country
United States
Facility Name
Clinical Research Ctr Reading /ID# 168070
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Nashville Arthritis and Rheumatology /ID# 168069
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Amarillo Ctr for Clin Research /ID# 208347
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions /ID# 208386
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Dallas VA Medical Center /ID# 208389
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions /ID# 210597
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Advanced Rheumatology of Houston /ID# 208354
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
DM Clinical Research /ID# 208351
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Kadlec Clinic Rheumatology /ID# 207969
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Rheumatology and Pulmonary Clinic /ID# 200446
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Aurora Rheumatology and Immunotherapy Center /ID# 168066
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Holy Family Memorial, Inc. /ID# 209387
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54220
Country
United States
Facility Name
Gundersen Clinic, Ltd /ID# 209459
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54650
Country
United States
Facility Name
Framingham Centro Medico /ID# 210409
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1902
Country
Argentina
Facility Name
Hospital General de Agudos J. M. Ramos Mejia /ID# 169164
City
Buenos Aires
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires /ID# 208474
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# 208479
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1111
Country
Argentina
Facility Name
Fundacion CIDEA /ID# 210494
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1121
Country
Argentina
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 211622
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciuadad Autonoma De Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169163
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Instituto CAICI /ID# 169168
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia /ID# 208343
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Duplicate_Inst de Rehab Psicofisica /ID# 214681
City
Buenos Aires
ZIP/Postal Code
2201
Country
Argentina
Facility Name
Duplicate_Hospital Privado Univesitario /ID# 211623
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Cimer /Id# 169167
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
The Canberra Hospital /ID# 207592
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital /ID# 212785
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Rheumatology Research Unit Sunshine Coast /ID# 207200
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Griffith University /ID# 207505
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Flinders Medical Centre /ID# 210562
City
Bedford, Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Emeritus Research /ID# 207202
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Monash Medical Centre /ID# 208034
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Duplicate_UZ Ghent /ID# 210036
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
ReumaClinic /ID# 208213
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
ZNA - Jan Palfijn /ID# 208212
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 208268
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 208269
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Centre of the Republic of Srpska /ID# 210047
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo /ID# 208272
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
SER - Serviços Especializados em Reumatologia /ID# 207489
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150-150
Country
Brazil
Facility Name
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
EDUMED Educacao em Saude S/S L /ID# 207488
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80440-080
Country
Brazil
Facility Name
LMK Sevicos Medicos S/S /ID# 207491
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
CPCLIN - Centro de Pesquisas Clínicas /ID# 207493
City
Sao Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Medical center Medconsult /ID# 211399
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Medical center Excelsior /ID# 167741
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Diagnostic consultative center 17 Sofia /ID# 210506
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
Military Medical Academy Multiprofile Hospital /ID# 210829
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Percuro Clinical Research, Ltd /ID# 169601
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
Manitoba Clinic /ID# 206819
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
CIADS Research Co Ltd /ID# 169600
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
Facility Name
SKIN Centre for Dermatology /ID# 169604
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
K. Papp Clinical Research /ID# 169603
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Groupe de Recherche en Maladies Osseuses Inc /ID# 169598
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Dr. Latha Naik /ID# 212188
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
CTR Estudios Clinicos /ID# 208166
City
Providencia
ZIP/Postal Code
7500571
Country
Chile
Facility Name
Centro Internacional de Estudios Clinicos /ID# 209908
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Clinica Dermacross S.A /ID# 208163
City
Vitacura Santiago
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Poliklinika Repromed /ID# 208628
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Solmed /ID# 210965
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
UHC Osijek /ID# 208623
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Klinicki bolnicki centar Rijeka /ID# 208621
City
Rijeka
State/Province
Primorsko-goranska Zupanija
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split /ID# 208626
City
Split
State/Province
Splitsko-dalmatinska Zupanija
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Medical Center Kuna-Peric /ID# 208047
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Bonifarm /ID# 208750
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025
City
Brno
ZIP/Postal Code
615 00
Country
Czechia
Facility Name
PV MEDICAL Services s.r.o. /ID# 210222
City
Praha
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
MUDr. Zuzana Stejfova - revmatologicka ambulance /ID# 209027
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Affidea Praha s.r.o. /ID# 210223
City
Praha
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
MEDICAL PLUS, s.r.o. /ID# 210439
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Bispebjerg and Frederiksberg Hospital /ID# 207576
City
Frederiksberg
State/Province
Hovedstaden
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Aarhus University Hospital /ID# 168761
City
Aarhus C
State/Province
Midtjylland
ZIP/Postal Code
8000
Country
Denmark
Facility Name
North Estonia Medical Centre /ID# 208325
City
Mustamäe Linnaosa
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Innomedica /ID# 211416
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10117
Country
Estonia
Facility Name
MediTrials /ID# 207816
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50708
Country
Estonia
Facility Name
Helsinki University Hospital /ID# 207724
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Facility Name
Ite Pihlajanlinna Kuopio /ID# 208322
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Turku University Hospital /ID# 207726
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Rheumazentrum Ruhrgebiet /ID# 207216
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44649
Country
Germany
Facility Name
Immanuel Krankenhaus Berlin /ID# 207218
City
Berlin-buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209483
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209484
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
General Hospital Asklepieio Voulas /ID# 212956
City
Athens
State/Province
Attiki
ZIP/Postal Code
16673
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 206839
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
424 General MILITARY Hospital /ID# 210974
City
Efkarpia (Thessalonikis)
State/Province
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Naval Hospital of Athens /ID# 206838
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Olympion General Clinic SA /ID# 207048
City
Patras
ZIP/Postal Code
26443
Country
Greece
Facility Name
Sheba Medical Center /ID# 207474
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5239424
Country
Israel
Facility Name
Barzilai Medical Center /ID# 207476
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 208170
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center /ID# 207473
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center /ID# 207475
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207269
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
A.O.U. Policlinico G. Rodolico S.Marco - Presidio San Marco /ID# 207795
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Duplicate_Policlinico Univ Tor Vergata /ID# 207271
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207265
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Hanyang University Seoul Hospital /ID# 209263
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Duplicate_Konkuk University Medical Ctr /ID# 207509
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Kyungpook National Univ Hosp /ID# 207408
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
M & M Centrs LTD /ID# 208733
City
Adazi
ZIP/Postal Code
LV-2164
Country
Latvia
Facility Name
D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 207224
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital /ID# 207220
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Clinic ORTO /ID# 216218
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Riga East Clinical University Hospital /ID# 207223
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
VAKK Dr. Kilda's Clinic /ID# 207330
City
Kaunas
ZIP/Postal Code
50128
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207331
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Klaipeda University Hospital /ID# 207329
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Republican Siauliai hospital /ID# 207328
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Hospital Tuanku Jaafar /ID# 207919
City
Seremban
State/Province
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Hospital Raja Permaisuri Bainun /ID# 207920
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Hospital Selayang /ID# 208938
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
University Malaya Med Ctr /ID# 208937
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Centro Integral en Reumatologia S.A de C.V /ID# 208346
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Eukarya PharmaSite, SC /ID# 208431
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Centro Peninsular de Investigación Clínica SCP /ID# 208345
City
Colonia Centro
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835
City
Ciudad de Mexico
ZIP/Postal Code
03100
Country
Mexico
Facility Name
RM Pharma Specialists S.A de C.V /ID# 208330
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Antonius Ziekenhuis /ID# 208587
City
Sneek
State/Province
Fryslan
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen /ID# 208580
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden /ID# 168453
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Middlemore Clinical Trials /ID# 213256
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Waikato Hospital /ID# 213257
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
CGM Research Trust /ID# 210498
City
Burwood
ZIP/Postal Code
8083
Country
New Zealand
Facility Name
Spolka Lekarzy INTERCOR /ID# 210191
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-605
Country
Poland
Facility Name
Nasz Lekarz Przychodnie Medyczne /ID# 216176
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Malopolskie Centrum Kliniczne /ID# 208007
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-149
Country
Poland
Facility Name
McBk Sc /Id# 209132
City
Grodzisk Mazowiecki
State/Province
Mazowieckie
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Centrum Medyczne Reuma Park w Warszawie /ID# 210352
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Osteo-Medic S.C. /ID# 208008
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp.j. /ID# 210824
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Centrum Kliniczno-Badawcze /ID# 208010
City
Elblag
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
ETYKA-Osrodek Badan Klinicznych /ID# 216241
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-117
Country
Poland
Facility Name
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208145
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208147
City
Ponte de Lima
State/Province
Viana Do Castelo
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Centro Hospitalar do Baixo Vouga /ID# 215979
City
Aveiro
ZIP/Postal Code
3810-164
Country
Portugal
Facility Name
CCA Braga - Hospital de Braga /ID# 208146
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Instituto Português De Reumatologia /ID# 208149
City
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208148
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Mindful Medical Research /ID# 211129
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Facility Name
Cabinet Medical Dr Triff Carina /Id# 207528
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300766
Country
Romania
Facility Name
Spitalul Clinic Sf. Maria /ID# 210054
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 207340
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic de Recuperare Iasi /ID# 207371
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
LLC Family Outpatient Clinic № /ID# 169510
City
Korolev
State/Province
Moskva
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
Research Institute of Rheumatology named after V.A. Nasonova /ID# 207643
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
LLC Medical Center /ID# 169516
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Nort-Western State Medical University n.a. Mechnikov /ID# 207641
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 169511
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Federal Center for Brain and Neurotechnology /ID# 207646
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Perm Regional Clinical Hospital /ID# 207642
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital /ID# 169515
City
Ulyanovsk
ZIP/Postal Code
432017
Country
Russian Federation
Facility Name
Institute for Rheumatology /ID# 168194
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 168197
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 168198
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Rheumatology /ID# 168199
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy /ID# 168218
City
Belgrade
State/Province
Beograd
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Special Hospital for Rheuma /ID# 168255
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Special Hospital for Rheuma /ID# 210284
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
National University Hospital /ID# 208599
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital /ID# 207917
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Changi General Hospital /ID# 208965
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
REUMA-GLOBAL, s.r.o. /ID# 208017
City
Biely Kostol
ZIP/Postal Code
919 34
Country
Slovakia
Facility Name
MEDMAN s.r.o. /ID# 208018
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Reum.hapi s.r.o. /ID# 208016
City
Nove Mesto nad Vahom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
Thermium s.r.o. /ID# 208015
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
REUMAMED POPRAD s.r.o. /ID# 208407
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Dr Jenny Potts /ID# 168691
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6405
Country
South Africa
Facility Name
University of Pretoria /ID# 167621
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Dr Elsa van Duuren /ID# 207577
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Arthritis Clinical Research Trials /ID# 167625
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Synexus Helderberg Clinical Research Centre /ID# 210891
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Winelands Medical Research Centre /ID# 167629
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 208543
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207830
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 207826
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Torrecardenas /ID# 212716
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Parc de Salut del Mar /ID# 209698
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 207832
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 207827
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 207831
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Orebro Universitetssjukhuset /ID# 207948
City
Orebro
State/Province
Orebro Lan
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Skane University hospital /ID# 210070
City
Malmo
State/Province
Skane Lan
ZIP/Postal Code
214 28
Country
Sweden
Facility Name
Falu Lasarett /ID# 210322
City
Falun
ZIP/Postal Code
791 31
Country
Sweden
Facility Name
Duplicate_Karolinska Univ Sjukhuset /ID# 208175
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Uppsala University Hospital /ID# 207944
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Duplicate_Vastmanlands Sjukhus /ID# 207943
City
Vasteras
ZIP/Postal Code
723 35
Country
Sweden
Facility Name
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567
City
Chia-Yi
ZIP/Postal Code
62247
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital /ID# 207257
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Ho /ID# 207255
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Scientific Research Institute of Invalid Rehabilitation /ID# 207873
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
CNE Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 207730
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
PNE City Multifunctional Hospital No.18 /ID# 207911
City
Kharkiv
ZIP/Postal Code
61029
Country
Ukraine
Facility Name
Khmelnytskyi Regional Hospital /ID# 207753
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
MI Kryvyi Rih City Clinical Hospital No.2 /ID# 207748
City
Kryvyi Rih
ZIP/Postal Code
50056
Country
Ukraine
Facility Name
Medical Center OK Clinic /ID# 207749
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 208276
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Facility Name
Lviv Municipal City Clinical Hospital #4 /ID# 207715
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 207872
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Public Institution 6th City Clinical Hospital /ID# 207754
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Duplicate_Barts Health NHS Trust /ID# 210534
City
London
State/Province
London, City Of
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde /ID# 214942
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
Midlands Partnership NHS Foundation Trust /ID# 214941
City
Stafford
State/Province
Staffordshire
ZIP/Postal Code
ST16 3SR
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 207928
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Portsmouth Hospitals University NHS Trust /ID# 207932
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Torbay and South Devon Nhs Foundation Trust /Id# 207931
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210535
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
34911706
Citation
Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022 Feb;81(2):225-231. doi: 10.1136/annrheumdis-2021-221019. Epub 2021 Dec 15.
Results Reference
result
PubMed Identifier
36282530
Citation
Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2113-2121. doi: 10.1093/rheumatology/keac607.
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
35801915
Citation
Kristensen LE, Soliman AM, Papp K, White D, Barcomb L, Lu W, Eldred A, Behrens F. Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1. Rheumatology (Oxford). 2023 Feb 1;62(2):629-637. doi: 10.1093/rheumatology/keac342.
Results Reference
derived
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M16-011
Description
Related Info
Learn more about this trial
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
We'll reach out to this number within 24 hrs