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A 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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675308
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in subjects with moderately to severely active psoriatic arthritis (PsA).

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Biological: placebo for rizankizumab Biological: risankizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : January 8, 2021
Estimated Study Completion Date : December 3, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants randomized to receive double-blind placebo for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).
Biological: placebo for rizankizumab
Placebo for risankizumab administered by subcutaneous (SC) injection

Biological: risankizumab
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Risankizumab
Participants randomized to receive double-blind risankizumab for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).
Biological: risankizumab
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066




Primary Outcome Measures :
  1. Percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20) at Week 24 [ Time Frame: Baseline, Week 24 ]
    ACR20 is defined as at least 20% improvement in swollen joint count, tender joint count, and at least 3 out of the following 5 variables: 1) Patient's Assessment of psoriatic arthritis (PsA) Pain Intensity visual analog scale (VAS), 2) Patient's Global Assessment of Disease VAS, 3) Physician's Global Assessment of Disease Activity VAS, 4) Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI), and 5) Serum high-sensitivity C-reactive protein (serum hs-CRP).


Secondary Outcome Measures :
  1. Change from Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 24 ]
    The HAQ-DI is a self-reported questionnaire of how the patient's illness affects their ability to function in their daily life over the past week.

  2. Percentage of Participants With ≥ 90% Reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 24 in Participants With ≥ 3% Body Surface Area (BSA) Involving Psoriasis at Baseline [ Time Frame: Baseline, Week 24 ]
    PASI90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.

  3. Change from Baseline to Week 24 in modified Total Sharp Score (PsA-mTSS) at Week 24 [ Time Frame: Baseline, Week 24 ]
    The modified PsA-mTSS method is used to evaluate radiographic evidence of damage.

  4. Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24 [ Time Frame: Baseline, Week 24 ]
    The percentage of participants who achieve MDA.

  5. Change from Baseline to Week 24 in Fingernail Psoriasis [ Time Frame: Baseline, Week 24 ]
    Fingernail psoriasis will be evaluated using either the Physician Global Assessment - Fingernails (PGA-F) or the modified Nail Psoriasis Severity Index (mNAPSI), depending on location.

  6. Change from Baseline to Week 24 in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline [ Time Frame: Baseline, Week 24 ]
    The LEI will be used to assess the presence or absence of enthesitis.

  7. Change from Baseline to Week 24 in Leeds Dactylitis Index (LDI) in Participants With Dactylitis at Baseline [ Time Frame: Baseline, Week 24 ]
    The LDI will be used to assess the presence or absence of dactylitis.

  8. Change from Baseline to Week 24 in the 36-Item Short Form Health Questionnaire (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, Week 24 ]
    The SF-36 is a 36-item, general health, self-administered questionnaire.

  9. Change from Baseline to Week 24 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire Score [ Time Frame: Baseline, Week 24 ]
    The FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Subject has active disease at Baseline
  • Diagnosis of active plaque psoriasis.
  • Subject has demonstrated an inadequate response or intolerance to conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

Exclusion Criteria:

  • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
  • Subject has a known hypersensitivity to risankizumab.
  • Subject has previous treatment with biologic agent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675308


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
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United States, Alabama
Pinnacle Research Group /ID# 167955 Recruiting
Anniston, Alabama, United States, 36207
United States, Arizona
SunValley Arthritis Center, Lt /ID# 200270 Recruiting
Peoria, Arizona, United States, 85381
AZ Arthritis and Rheum Researc /ID# 209873 Not yet recruiting
Phoenix, Arizona, United States, 85032-9306
Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875 Not yet recruiting
Tucson, Arizona, United States, 85704
Southern Arizona VA Health Care System /ID# 209247 Not yet recruiting
Tucson, Arizona, United States, 85723
United States, Arkansas
Arthritis and Rheumatism Associates /ID# 209882 Recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
Valerius Med Grp & Res Ctr /ID# 207428 Recruiting
Los Alamitos, California, United States, 90720-5402
Iraj Sabahi Research, Inc /ID# 208353 Not yet recruiting
Turlock, California, United States, 95382-2007
Inland Rheum Clin Trials Inc. /ID# 201641 Recruiting
Upland, California, United States, 91786
Medvin Clinical Research /ID# 211127 Recruiting
Whittier, California, United States, 90606
United States, Connecticut
New England Research Associates, LLC /ID# 207237 Recruiting
Bridgeport, Connecticut, United States, 06606-1827
Danbury Clinical Research, LLC /ID# 209517 Recruiting
Danbury, Connecticut, United States, 06810
Yale University /ID# 207236 Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
AARDS Research, Inc. /ID# 210802 Recruiting
Aventura, Florida, United States, 33180
RASF - Clinical Research /ID# 211099 Recruiting
Boca Raton, Florida, United States, 33486
Southeastern Integrated Med /ID# 207461 Recruiting
Gainesville, Florida, United States, 32607
Sweet Hope Research Specialty Inc /ID# 209393 Recruiting
Hialeah, Florida, United States, 33016-1897
River City Clinical Research /ID# 209876 Recruiting
Jacksonville, Florida, United States, 32207-8210
Rheum Assoc of Central FL /ID# 201622 Recruiting
Orlando, Florida, United States, 32806
Heuermd Research Inc /Id# 208427 Recruiting
Orlando, Florida, United States, 32819
Integral Rheumatology & Immunology Specialists /ID# 208955 Recruiting
Plantation, Florida, United States, 33324
ForCare Clinical Research /ID# 168034 Recruiting
Tampa, Florida, United States, 33613-1244
United States, Georgia
Arthritis and Rheumatology /ID# 168046 Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Affinity Health /ID# 210816 Recruiting
Oak Brook, Illinois, United States, 60523-1245
OrthoIllinois /ID# 205300 Not yet recruiting
Rockford, Illinois, United States, 60152
Springfield Clinic /ID# 200244 Recruiting
Springfield, Illinois, United States, 62703
United States, Maryland
Klein & Associates, M.D., P.A. /ID# 169483 Recruiting
Cumberland, Maryland, United States, 21502
The Center for Rheumatology & /ID# 168017 Recruiting
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Clinical Pharmacology Study Gr /ID# 168019 Recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Advanced Rheumatology, PC /ID# 168042 Recruiting
Lansing, Michigan, United States, 48910
June DO, PC /ID# 208915 Recruiting
Lansing, Michigan, United States, 48910
United States, Minnesota
Saint Paul Rheumatology /ID# 208471 Recruiting
Eagan, Minnesota, United States, 55121
United States, Montana
Glacier View Research Institut /ID# 213707 Not yet recruiting
Kalispell, Montana, United States, 59901
United States, Nebraska
Physician Res. Collaboration /ID# 208670 Recruiting
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Arthritis and Osteoporosis Ass /ID# 210906 Not yet recruiting
Freehold, New Jersey, United States, 07728
United States, New York
Center for Rheumatology LLP /ID# 207313 Not yet recruiting
Albany, New York, United States, 12203
NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310 Not yet recruiting
Brooklyn, New York, United States, 11201
United States, North Carolina
Joint & Muscle Research Instit /ID# 208620 Not yet recruiting
Charlotte, North Carolina, United States, 28204
Medication Management, LLC /ID# 211734 Not yet recruiting
Greensboro, North Carolina, United States, 27408
Coastal Carolina Health Care /ID# 208619 Recruiting
New Bern, North Carolina, United States, 28562
United States, Ohio
New Horizons Clinical Research /ID# 200452 Recruiting
Blue Ash, Ohio, United States, 45242-3763
Marietta Memorial Hospital /ID# 210179 Recruiting
Marietta, Ohio, United States, 45750-1635
Paramount Medical Research Con /ID# 201583 Recruiting
Middleburg Heights, Ohio, United States, 44130
STAT Research, Inc. /ID# 213805 Recruiting
Springboro, Ohio, United States, 45066-9168
United States, Oklahoma
Health Research Oklahoma /ID# 168027 Recruiting
Oklahoma City, Oklahoma, United States, 73103-2400
United States, Pennsylvania
Altoona Ctr Clinical Res /ID# 168037 Recruiting
Duncansville, Pennsylvania, United States, 16635
Allegheny-Singer Research Institute dba AHN Research Institute /ID# 210349 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212-4756
Clinical Research Ctr Reading /ID# 168070 Not yet recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
RIH / Alpert Medical School /ID# 207232 Not yet recruiting
Providence, Rhode Island, United States, 02915
United States, Tennessee
Nashville Arthritis and Rheumatology /ID# 168069 Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Amarillo Ctr for Clin Research /ID# 208347 Recruiting
Amarillo, Texas, United States, 79124
PCCR Solution /ID# 208386 Recruiting
Colleyville, Texas, United States, 76034
Dallas VA Medical Center /ID# 208389 Not yet recruiting
Dallas, Texas, United States, 75216
PCCR Solutions /ID# 210597 Recruiting
Fort Worth, Texas, United States, 76107-6644
Adv Rheumatology of Houston /ID# 208354 Recruiting
The Woodlands, Texas, United States, 77382
DM Clinical Research /ID# 208351 Recruiting
Tomball, Texas, United States, 77375
United States, Washington
Kadlec Clinic Rheumatology /ID# 207969 Recruiting
Kennewick, Washington, United States, 99336
United States, West Virginia
Rheumatology and Pulmonary cli /ID# 200446 Recruiting
Beckley, West Virginia, United States, 25801
United States, Wisconsin
Rheumatology and Immunotherapy Center /ID# 168066 Not yet recruiting
Franklin, Wisconsin, United States, 53132
Holy Family Memorial, Inc. /ID# 209387 Completed
Manitowoc, Wisconsin, United States, 54220
Gundersen Clinic, Ltd /ID# 209459 Recruiting
Onalaska, Wisconsin, United States, 54650
Argentina
Hospital Italiano de Buenos Aires /ID# 208474 Not yet recruiting
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1199
Framingham Centro Medico /ID# 210409 Not yet recruiting
La Plata, Buenos Aires, Argentina, 1902
Fundacion CIDEA /ID# 210494 Recruiting
Buenos Aires, Argentina, 1121
Hospital General de Agudos Ram /ID# 169164 Recruiting
Buenos Aires, Argentina, C1221ADC
Hospital Militar Central Ciruj /ID# 211622 Not yet recruiting
Buenos Aires, Argentina, C1426BOR
Inst de Rehab Psicofisica /ID# 214681 Not yet recruiting
Buenos Aires, Argentina, C1428DQG
DOM Centro de Reumatologia /ID# 208479 Recruiting
Ciudad Autonoma Buenos Aires, Argentina, 1111
Hosp Privado Ctr Med Cordoba /ID# 211623 Not yet recruiting
Cordoba, Argentina, 5016
Instituto CAICI /ID# 169168 Recruiting
Rosario, Santa FE, Argentina, 2000
Centro Medico Privado/Reuma /ID# 208343 Recruiting
San Miguel de Tucuman, Argentina, 4000
Cimer /Id# 169167 Recruiting
San Miguel de Tucuman, Argentina, 4000
Centro de Enfermedades /ID# 169163 Not yet recruiting
Santa Fe, Argentina, 2000
Australia, Australian Capital Territory
The Canberra Hospital /ID# 207592 Not yet recruiting
Garran, Australian Capital Territory, Australia, 2605
Australia, Queensland
Royal Brisbane and Women's Hospital /ID# 212785 Not yet recruiting
Herston, Queensland, Australia, 4029
Rheumatology Research Unit /ID# 207200 Recruiting
Maroochydore, Queensland, Australia, 4558
Griffith University /ID# 207505 Recruiting
Southport, Queensland, Australia, 4222
Australia, South Australia
Flinders Medical Centre /ID# 210562 Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Emeritus Research /ID# 207202 Recruiting
Camberwell, Victoria, Australia, 3124
Monash Health /ID# 208034 Recruiting
Clayton, Victoria, Australia, 3168
Belgium
UZ Gent /ID# 210036 Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Reuma clinic /ID# 208213 Recruiting
Genk, Belgium, 3600
ZNA - Jan Palfijn /ID# 208212 Not yet recruiting
Merksem, Belgium, 2170
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 208268 Recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 208269 Recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 210047 Recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
Clinical Center University of Sarajevo /ID# 208272 Not yet recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
SER - Serviços Especializados em Reumatologia da Bahia. /ID# 207489 Not yet recruiting
Salvador, Bahia, Brazil, 40150-150
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496 Not yet recruiting
Juiz de Fora, Minas Gerais, Brazil, 36010-570
EDUMED Educacao em Saude S/S L /ID# 207488 Not yet recruiting
Curitiba, Parana, Brazil, 80440-080
LMK Sevicos Medicos S/S /ID# 207491 Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 211783 Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
CPCLIN - Centro de Pesquisas Clínicas /ID# 207493 Not yet recruiting
Sao Paulo, Brazil, 01244-030
Bulgaria
Medical Center Medconsult /ID# 211399 Not yet recruiting
Pleven, Bulgaria, 5800
MHAT Kaspela /ID# 210505 Not yet recruiting
Plovdiv, Bulgaria, 4001
MHAT-Plovdiv AD /ID# 167739 Not yet recruiting
Plovdiv, Bulgaria, 4003
Excelsior Medical Center /ID# 167741 Not yet recruiting
Sofia, Bulgaria, 1407
Diag Consult Ctr 17 Sofia EOOD /ID# 210506 Not yet recruiting
Sofia, Bulgaria, 1505
Multiprofile Hospital for Active Treatment - Sofia at Military Medical Academy /ID# 210829 Not yet recruiting
Sofia, Bulgaria, 1606
Medical Center Academy /ID# 211467 Not yet recruiting
Sofia, Bulgaria, 1612
UMHAT Sv. Ivan Rilski /ID# 167742 Not yet recruiting
Sofia, Bulgaria, 1612
Canada, British Columbia
Percuro Clinical Research, Ltd /ID# 169601 Recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, Manitoba
Manitoba Clinic /ID# 206819 Recruiting
Winnipeg, Manitoba, Canada, R3A IM3
CIADS Research Co Ltd /ID# 169600 Recruiting
Winnipeg, Manitoba, Canada, R3N 0K6
Canada, Ontario
SKIN Centre for Dermatology /ID# 169604 Recruiting
Peterborough, Ontario, Canada, K9J 5K2
K. Papp Clinical Research /ID# 169603 Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Groupe de Recherche en Maladies Osseuses /ID# 169598 Recruiting
Sainte-foy, Quebec, Canada, G1V 3M7
Canada, Saskatchewan
Dr. Latha Naik /ID# 212188 Recruiting
Saskatoon, Saskatchewan, Canada, S7K 3H3
Chile
Servicio de Salud Atacama Hospital Regional Copiapo San Jose del Carmen /ID# 209203 Not yet recruiting
Copiapó, Atacama, Chile, 1530134
Research Group Ltda /ID# 208164 Not yet recruiting
Santiago, Region Metropolitana De Santiago, Chile, 2540364
CTR Estudios SpA /ID# 208166 Not yet recruiting
Providencia, Chile, 7500571
Centro Inter Estud Clin CIEC /ID# 209908 Not yet recruiting
Santiago, Chile, 8420383
Clinica Univ Catolica del Maul /ID# 210380 Not yet recruiting
Talca, Chile, 3460000
Clínica Dermacross S.A /ID# 208163 Not yet recruiting
Vitacura, Santiago, Chile, 7640881
Croatia
Poliklinika Repromed /ID# 208628 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Poliklinika Solmed /ID# 210965 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Osijek /ID# 208623 Recruiting
Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
Klinicki bolnicki centar Rijeka /ID# 208621 Recruiting
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Klinicki bolnicki centar Split /ID# 208626 Recruiting
Split, Croatia, 21000
Medical Center Kuna-Peric /ID# 208047 Recruiting
Zagreb, Croatia, 10000
Poliklinika Bonifarm /ID# 208750 Recruiting
Zagreb, Croatia, 10000
Czechia
Nuselská poliklinika, Revmatologie /ID# 209027 Recruiting
Prague 4, Praha 4, Czechia, 140 00
PV MEDICAL Services s.r.o. /ID# 210222 Recruiting
Zlín 1, Zlin, Czechia, 760 01
Revmacentrum BRNO /ID# 209025 Recruiting
Brno-zidenice, Czechia, 615 00
Reumatologicka ambulancia /ID# 210223 Recruiting
Prague, Czechia, 149 00
Medical Plus, s.r.o. /ID# 210439 Recruiting
Uherské Hradište, Czechia, 686 01
Denmark
Aarhus Universitetshospital /ID# 168761 Recruiting
Aarhus C, Midtjylland, Denmark, 8000
Frederiksberg Hospital /ID# 207576 Recruiting
Frederiksberg, Denmark, 2000
Estonia
MediTrials /ID# 207816 Recruiting
Tartu, Tartumaa, Estonia, 50406
Innomedica /ID# 211416 Recruiting
Tallinn, Estonia, 10117
North Estonian Medical Centre /ID# 208325 Not yet recruiting
Tallinn, Estonia, 13419
Finland
Helsinki Univ Central Hospital /ID# 207724 Recruiting
Helsinki, Finland, 00290
Ite Pihlajanlinna Kuopio /ID# 208322 Recruiting
Kuopio, Finland, 70100
Turku University Hospital /ID# 207726 Not yet recruiting
Turku, Finland, 20520
Germany
Rheumazentrum Ruhrgebiet /ID# 207216 Not yet recruiting
Herne, Nordrhein-Westfalen, Germany, 44649
Immanuel-Krankenhaus /ID# 207218 Recruiting
Berlin-buch, Germany, 13125
Cent fur Innovative Diagnostik /ID# 209483 Not yet recruiting
Frankfurt, Germany, 60590
Rheumaforschungszentrum II /ID# 209484 Recruiting
Hamburg, Germany, 20095
Greece
General Hospital Asklepieio Voulas /ID# 212956 Not yet recruiting
Athens, Attiki, Greece, 16673
Naval Hospital of Athens /ID# 206838 Recruiting
Athens, Greece, 11521
University General Hospital of Heraklion "PA.G.N.I" /ID# 206839 Recruiting
Heraklion, Greece, 71110
Olympion General Clinic SA /ID# 207048 Recruiting
Patras, Greece, 26443
424 General MILITARY Hospital /ID# 210974 Not yet recruiting
Thessaloniki, Greece, 56429
Israel
Rabin Medical Center /ID# 207475 Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Barzilai Medical Center /ID# 207476 Recruiting
Ashkelon, Israel, 78278
Rambam Health Care Campus /ID# 208170 Recruiting
Haifa, Israel, 3109601
Meir Medical Center /ID# 207473 Recruiting
Kfar Saba, Israel, 44281
Sheba Medical Center /ID# 207474 Recruiting
Ramat Gan, Israel, 5262100
Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799 Not yet recruiting
Modena, Emilia-Romagna, Italy, 41124
AOU Ospedali Riuniti di Ancona - G.M. Lancisi, G. Salesi /ID# 207269 Recruiting
Ancona, Marche, Italy, 60126
AOU Policlinico Vittorio Emanuele /ID# 207795 Not yet recruiting
Catania, Italy, 95124
Policlinico Univ Tor Vergata /ID# 207271 Not yet recruiting
Rome, Italy, 00133
Ospedale Policlinico G. B. Ros /ID# 207265 Not yet recruiting
Verona, Italy, 37126
Korea, Republic of
Kyungpook National Univ Hosp /ID# 207408 Not yet recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
Hanyang University Seoul Hospi /ID# 209263 Recruiting
Seongdong-gu, Seoul Teugbyeolsi, Korea, Republic of, 04763
Konkuk University Medical Ctr /ID# 207509 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
Latvia
LTD M+M Centers /ID# 208733 Recruiting
Adazi, Latvia, 2164
D.Saulites-Kandevicas PP /ID# 207224 Recruiting
Liepaja, Latvia, 3401
Clinic ORTO /ID# 216218 Not yet recruiting
Riga, Latvia, 1005
Riga East Clinical Univ Hosp /ID# 207223 Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 207220 Recruiting
Riga, Latvia, LV-1002
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 207331 Recruiting
Kovno, Kaunas, Lithuania, 50009
VAKK dr. Kildos Clinic /ID# 207330 Recruiting
Kaunas, Lithuania, 50128
Klaipeda University Hospital /ID# 207329 Recruiting
Klaipeda, Lithuania, 92288
Public Institution Republican /ID# 207328 Recruiting
Siauliai, Lithuania, 76231
National Osteporosis Center /ID# 211512 Not yet recruiting
Vilnius, Lithuania, 09310
Malaysia
Hospital Raja Permaisuri Bainun /ID# 207920 Recruiting
Ipoh, Perak, Malaysia, 30450
Hospital Selayang /ID# 208938 Recruiting
Batu Caves, Malaysia, 68100
University Malaya Med Ctr /ID# 208937 Recruiting
Kuala Lumpur, Malaysia, 59100
Hospital Tuanku Ja afar /ID# 207919 Recruiting
Seremban, Malaysia, 70300
Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331 Recruiting
Mexico City, Ciudad De Mexico, Mexico, 11850
Centro Integral en Reumatología S.A de C.V /ID# 208346 Recruiting
Guadalajara, Jalisco, Mexico, 44160
Consultorio Privado /ID# 211667 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44657
Hospital Universitario "Dr. José Eleuterio González" /ID# 208344 Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Eukarya PharmaSite, SC /ID# 208431 Recruiting
Monterrey, Nuevo Leon, Mexico, 64718
Centro Peninsular de Investigación Clínica SCP /ID# 208345 Recruiting
Colonia Centro, Yucatan, Mexico, 97000
Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835 Not yet recruiting
Ciudad de Mexico, Mexico, 03100
RM Pharma Specialists, S.A de C.V /ID# 208330 Recruiting
Mexico City, Mexico, 03100
Netherlands
Antonius Ziekenhuis /ID# 208587 Not yet recruiting
Sneek, Fryslan, Netherlands, 8601 ZK
Universitair Medisch Centrum Groningen /ID# 208580 Recruiting
Groningen, Netherlands, 9713 GZ
Medisch Centrum Leeuwarden /ID# 168453 Not yet recruiting
Leeuwarden, Netherlands, 8934 AD
New Zealand
Waikato Hospital /ID# 213257 Recruiting
Hamilton, Waikato, New Zealand, 3204
Middlemore Hospital /ID# 213256 Recruiting
Auckland, New Zealand, 2025
CGM Research Trust /ID# 210498 Recruiting
Burwood Christchurch, New Zealand, 8083
Poland
Malopolskie Centrum Kliniczne /ID# 208007 Recruiting
Cracow, Malopolskie, Poland, 30-149
McBk Sc /Id# 209132 Recruiting
Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
Centrum Reumatologii Reumatika /ID# 210352 Recruiting
Warsaw, Mazowieckie, Poland, 02-691
Osteo-Medic S.C. /ID# 208008 Recruiting
Białystok, Podlaskie, Poland, 15-351
ClinicMed Daniluk, Nowak Sp.j. /ID# 210824 Recruiting
Białystok, Podlaskie, Poland, 15-879
Centrum Medyczne "INTERCOR" /ID# 210191 Recruiting
Bydgoszcz, Poland, 85-605
Centrum Kliniczno-Badawcze /ID# 208010 Recruiting
Elblag, Poland, 82-300
Portugal
Instituto Portugues De Reumatologia /ID# 208149 Recruiting
Lisbon, Lisboa, Portugal, 1050-034
Centro Hospitalar De Vila Nova /ID# 208145 Not yet recruiting
Vila Nova De Gaia, Porto, Portugal, 4434-502
Hospital de Braga /ID# 208146 Recruiting
Braga, Portugal, 4710-423
Centro Hospitalar Lisboa Norte, EPE /ID# 208148 Recruiting
Lisboa, Portugal, 1649-035
Centro Hospitalar Baixo Vouga /ID# 215979 Not yet recruiting
Porto, Portugal, 4050-111
Unidade Local De Saude Do Alto Minho /ID# 208147 Recruiting
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
Mindful Medical Research /ID# 211129 Recruiting
San Juan, Puerto Rico, 00918-3756
Romania
Cabinet Medical Dr Triff Carina /Id# 207528 Recruiting
Timişoara, Timis, Romania, 300766
Spitalul Clinic Sf. Maria /ID# 210054 Recruiting
Bucuresti, Romania, 011172
Spitalul Clinic Judetean de Urgenta /ID# 207340 Recruiting
Cluj, Romania, 400006
Rehabilitation Clinical Hosp /ID# 207371 Not yet recruiting
Iasi, Romania, 700661
Russian Federation
NW State Medical Univ na Mechn /ID# 207641 Recruiting
St. Petersburg, Leningradskaya Oblast, Russian Federation, 191015
LLC Family Outpatient Clinic № /ID# 169510 Recruiting
Korolev, Moskva, Russian Federation, 141060
FSFSI SRI of Rheumatology n.a.V.A.Nasonova /ID# 207643 Not yet recruiting
Moscow, Moskva, Russian Federation, 115522
LLC Medical Center /ID# 169516 Not yet recruiting
Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
Kazan State Medical University /ID# 169511 Recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Russian National Research Medi /ID# 207646 Not yet recruiting
Moscow, Russian Federation, 117997
Perm Region Clinical Hospital /ID# 207642 Recruiting
Perm, Russian Federation, 614000
Ulyanovsk Regional Clinical Ho /ID# 169515 Recruiting
Ulyanovsk, Russian Federation, 432000
Serbia
Institute for Rheumatology /ID# 168194 Recruiting
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 168197 Recruiting
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 168198 Recruiting
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 168199 Recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 168218 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Special Hospital for Rheuma /ID# 168255 Recruiting
Novi Sad, Vojvodina, Serbia, 21000
Special Hospital for Rheuma /ID# 210284 Recruiting
Novi Sad, Vojvodina, Serbia, 21000
Singapore
National University Hospital /ID# 208599 Not yet recruiting
Singapore, Singapore, 119074
Singapore General Hospital /ID# 207917 Not yet recruiting
Singapore, Singapore, 169608
Changi General Hospital /ID# 208965 Not yet recruiting
Singapore, Singapore, 529889
Slovakia
MEDMAN s.r.o. /ID# 208018 Recruiting
Martin, Slovakia, 036 01
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 208016 Not yet recruiting
Nové Mesto Nad Váhom, Slovakia, 915 01
Slovak research center Team Member, Thermium s.r.o. /ID# 208015 Not yet recruiting
Pieštany, Slovakia, 921 01
REUMAMED POPRAD s.r.o. /ID# 208407 Not yet recruiting
Poprad, Slovakia, 058 01
REUMA-GLOBAL, s.r.o. /ID# 208017 Not yet recruiting
Trnava, Slovakia, 91701
South Africa
Dr Jenny Potts /ID# 168691 Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6405
University of Pretoria /ID# 167621 Recruiting
Pretoria, Gauteng, South Africa, 0001
Jakaranda Hospital /ID# 207577 Recruiting
Pretoria, Gauteng, South Africa, 0002
Synexus Helderberg Clinical Tr /ID# 210891 Recruiting
Cape Town, Western Cape, South Africa, 7130
Arthritis Clinical Research Tr /ID# 167625 Recruiting
Cape Town, Western Cape, South Africa, 7405
Winelands Medical Research Ctr /ID# 167629 Recruiting
Stellenbosch, Western Cape, South Africa, 7600
Spain
Corporac Sanitaria Parc Tauli /ID# 207830 Recruiting
Sabadell, Barcelona, Spain, 08208
H.U. Clinico San Carlos /ID# 207832 Not yet recruiting
Madrid, Madrid, Comunidad De, Spain, 28040
Comple Hosp Univ de A Coruna /ID# 207826 Recruiting
A Coruna, Spain, 15006
Complejo Hosp Torrecardenas /ID# 212716 Not yet recruiting
Almería, Spain, 04009
Hospital Parc de Salut del Mar /ID# 209698 Not yet recruiting
Barcelona, Spain, 08003
Hospital Univ Germans Trias I /ID# 208543 Not yet recruiting
Barcelona, Spain, 08916
Hosp Univ 12 de Octubre /ID# 207827 Not yet recruiting
Madrid, Spain, 28041
Hospital Universitario La Fe /ID# 207831 Not yet recruiting
Valencia, Spain, 46026
Sweden
Skanes Universitetssjukhus /ID# 210070 Recruiting
Malmö, Skane Lan, Sweden, 214 28
Falu Lasarett /ID# 210322 Recruiting
Falun, Sweden, 791 31
Orebro Universitetssjukhuset /ID# 207948 Recruiting
Orebro, Sweden, 70185
Karolinska Univ Sjukhuset /ID# 208175 Recruiting
Solna, Sweden, 17176
Uppsala University Hospital /ID# 207944 Recruiting
Uppsala, Sweden, 75185
Vastmanlands Sjukhus /ID# 207943 Recruiting
Vasteras, Sweden, 72189
Taiwan
Dalin Tzu Chi General Hospital /ID# 207567 Recruiting
Dalin Township, Taiwan, 622
Chung Shan Medical University /ID# 207257 Recruiting
Taichung City, Taiwan, 40201
Linkou Chang Gung Memorial Ho /ID# 207255 Recruiting
Taoyuan City, Taiwan, 33305
Ukraine
SI Inst of Therapy AMS of UA /ID# 209556 Not yet recruiting
Kharkiv, Kharkivska Oblast, Ukraine, 61039
Medical Centre of OK!Clinic of International Institute of Clinical Trials /ID# 207749 Not yet recruiting
Kiev, Kyivska Oblast, Ukraine, 02091
Clinical Research & Consulting /ID# 207873 Not yet recruiting
Vinnytsia, Vinnytska Oblast, Ukraine, 21005
Volyn regional clinical hospital /ID# 208276 Not yet recruiting
Lutsk, Volynska Oblast, Ukraine, 43005
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912 Not yet recruiting
Cherkasy, Ukraine, 18009
Municipal health care institution Chernihiv Regional Hospital /ID# 207730 Not yet recruiting
Chernihiv, Ukraine, 14029
Municipal Nonprofit Institution Kharkiv city multi-profile hospital №18 of Kh /ID# 207911 Not yet recruiting
Kharkiv, Ukraine, 61029
Khmelnitskyi Regional Clinical Hospital /ID# 207753 Not yet recruiting
Khmelnitskyi, Ukraine, 29000
Municipal Institution Kryvyi Rih City Clinical Hospital #2 of Dnipropetrovsk Re /ID# 207748 Not yet recruiting
Kryvyi Rih, Ukraine, 50056
Lviv Municipal City Clinical /ID# 207715 Not yet recruiting
Lviv, Ukraine, 79007
Poltava regional clinical hospital n. a. M.V. Sklifosovsky /ID# 207872 Not yet recruiting
Poltava, Ukraine, 36011
City Clinical Hospital #6 /ID# 207754 Not yet recruiting
Zaporizhia, Ukraine, 69035
United Kingdom
Whipps Cross Univ Hospital /ID# 210534 Not yet recruiting
London, London, City Of, United Kingdom, E11 1NR
Glasgow Royal Infirmary /ID# 214942 Not yet recruiting
Glasgow, United Kingdom, G4 0SF
Manchester Royal Infirmary, Ma /ID# 207928 Not yet recruiting
Manchester, United Kingdom, M13 9WL
Queen Alexandra Hospital /ID# 207932 Not yet recruiting
Portsmouth, United Kingdom, PO6 3LY
Haywood Hospital /Id# 214941 Not yet recruiting
Stoke on Trent, United Kingdom, ST6 7AG
Torbay and South Devon /Id# 207931 Not yet recruiting
Torquay, United Kingdom, TQ2 7AA
Arrowe Park Hospital /ID# 210535 Not yet recruiting
Wirral, United Kingdom, CH49 5PE
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03675308     History of Changes
Other Study ID Numbers: M16-011
2017-002465-22 ( EudraCT Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs