A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
- Registration Number
- NCT03151551
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 566
- Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
- Presence of active plaque psoriasis with a BSA ≥3%
- Men must agree to use a reliable method of birth control or remain abstinent during the study
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
- Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
- Current or prior use of biologic agents for treatment of Ps or PsA
- Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- Serious disorder or illness other than psoriatic arthritis
- Serious infection within the last 3 months
- Active Crohn's disease or active ulcerative colitis
- Active vasculitis or uveitis
- Diagnosis of or history of malignant disease <5 years prior to randomization
- Women who are breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adalimumab Adalimumab 80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps. Ixekizumab Ixekizumab 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.
- Primary Outcome Measures
Name Time Method Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) Week 24 ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\& swollen joint count (SJC)\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \& BSA=0 at week 24.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving PASI100 Week 24 PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if \& only if they had achieved PASI=0 \& BSA=0 at week 24.
Percentage of Participants Achieving ACR50 Week 24 ACR50 response is defined as a ≥50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).
Trial Locations
- Locations (131)
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Krishna Institute of Medical Sciences Ltd.
🇮🇳Secunderabad, Telengana, India
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Addenbrookes Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Government Medical College & Sir Sayajirao General Hospital
🇮🇳Vadodara, Gujarat, India
Kantonsspital St. Gallen
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
🇦🇹Wien, Austria
Narayana Hrudayalaya Hospital
🇮🇳Bangalore, Karnataka, India
Whipps Cross University Hospital
🇬🇧London, Surrey, United Kingdom
Rambam Medical Center
🇮🇱Haifa, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Arthritis Clinical Research Trial Unit
🇿🇦Pinelands, Western Cape, South Africa
Barzilai Medical Center
🇮🇱Ashkelon, Israel
"Dermed" Centrum Medyczne Sp. z o.o.
🇵🇱Lodz, Poland
Wishaw General Hospital
🇬🇧Wishaw, North Lanarkshire, United Kingdom
Ruby Hall Clinic and Grant Medical Foundation
🇮🇳Pune, Maharashtra, India
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Rheumatology, The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Atencion Integral en Reumatología
🇦🇷Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
CER Instituto Medico
🇦🇷Quilmes, Buenos Aires, Argentina
Clinica Adventista de Belgrano
🇦🇷Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital Ramos Mejia
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Instituto de Asist Reumatologica Integral
🇦🇷San Fernando, Buenos Aires, Argentina
Centre hospitalier universitaire Lapeyronie
🇫🇷Montpellier Cedex 5, France
Southern Clinical Research Pty Ltd
🇦🇺Hobart, Tasmania, Australia
Nouvel Hôpital Orléans La Source
🇫🇷Orleans CEDEX 2, France
Instituto Centenario
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
CENUDIAB
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Organizacion Medica de Investigacion - OMI
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Reumaclinic
🇧🇪Genk, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Saint Joseph Hospital
🇧🇪Gilly, Belgium
Combined Rheumatology Practice (CRP)
🇦🇺Kogarah, New South Wales, Australia
The Waterside Clinic
🇨🇦Barrie, Ontario, Canada
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
🇦🇷San Juan, Argentina
Rheuma-Zentrum Wien Oberlaa
🇦🇹Wien, Austria
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
St Vincents Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
AKH
🇦🇹Wien, Austria
Helsinki University Hospital, HYKS
🇫🇮Helsinki, Finland
Group de recherche en maladies osseuses
🇨🇦Quebec, Canada
Hopital Ambroise Pare
🇧🇪Mons, Belgium
Kiljava Medical Research
🇫🇮Hyvinkaa, Finland
Terveystalo Kouvola
🇫🇮Kouvola, Finland
SKiN Center for Dermatology
🇨🇦Peterborough, Ontario, Canada
Frederiksberg Hospital
🇩🇰Frederiksberg, Hovedstaden, Denmark
Aalborg Universitetshospital - Psykiatrien
🇩🇰Aalborg, Denmark
Centre Hospitalier de Vendee Les Oudairies
🇫🇷La Roche Sur Yon, France
Hôpital Pierre-Paul Riquet
🇫🇷Toulouse cedex 9, France
Rheumazentrum Ratingen
🇩🇪Ratingen, Nordrhein-Westfalen, Germany
Turun Yliopistollinen Keskussairaala
🇫🇮Turku, Finland
HRF Hamburger Rheuma Forschungszentrum
🇩🇪Hamburg, Germany
Klinikum der Universität München
🇩🇪München, Bayern, Germany
Hôpital Trousseau, CHRU de Tours
🇫🇷Chambray-lès-Tours, France
Hopital Edouard Herriot
🇫🇷Lyon Cedex 03, France
Vital Medical Center
🇭🇺Veszprem, Hungary
Artemis Hospital
🇮🇳Gurgaon, Haryana, India
King George Hospital
🇮🇳Visakhapatnam, Andhra Pradesh, India
Byramjee Jeejeebhoy Medical College & Civil Hospital
🇮🇳Ahmedabad, Gujarat, India
Allergo-Derm Bakos Kft
🇭🇺Szolnok, Jasz-Nagykun-Szolnok, Hungary
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
🇮🇳Mumbai, Maharashtra, India
Obudai Egeszsegugyi Centrum Kft
🇭🇺Budapest, Hungary
Care Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
UNO Medical Trials Kft.
🇭🇺Budapest, Hungary
Panchshil Hospital
🇮🇳Ahmedabad, Gujarat, India
Shalby Hospital
🇮🇳Ahmedabad, Gujarat, India
Meir Medical Center
🇮🇱Kfar Saba, Israel
CIMAB S.A. de C.V.
🇲🇽Torreon, Coahuila, Mexico
Apollo Gleneagles Hospitals
🇮🇳Kolkata, West Bengal, India
Centro Medico del Angel S.C.
🇲🇽Mexicali, Baja California, Mexico
Carmel Medical Center
🇮🇱Haifa, Israel
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Presidio Ospedaliero Vittorio Emanuele
🇮🇹Catania, Italy
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
Complesso Integrato Columbus
🇮🇹Roma, Italy
Centro Investigacion de Tratam Innovadores de Sinaloa SC
🇲🇽Culiacan, Sinaloa, Mexico
Fondazione Universitaria degli Studi G D'Annunzio
🇮🇹Chieti, Italy
Ctro Inv en Artritis y Osteoporosis SC
🇲🇽Mexicali, Baja California, Mexico
Grupo Médico CAMINO S.C.
🇲🇽México City, Distrito Federal, Mexico
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
🇲🇽Morelia, Michoacan, Mexico
NZOZ Centrum Reumatologiczne Ind. Prak.
🇵🇱Elblag, Poland
St Augustines Hospital
🇿🇦Durban, South Africa
Cemdeicy S.C.P.
🇲🇽Merida, Yucatán, Mexico
Suite 509 Umhlanga Netcare Medical Centre
🇿🇦Durban, KwaZulu-Natal, South Africa
RM Pharma Specialists S.A. de C.V.
🇲🇽Distrito Federal, Mexico
Twoja Przychodnia-Centrum Medyczne Nowa Sol
🇵🇱Nowa Sol, Poland
Rheuma Medicus Zakład Opieki Zdrowotnej
🇵🇱Warsaw, Poland
Greenacres Hospital
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Clinresco Centres (Pt) Ltd
🇿🇦Johannesburg, Gauteng, South Africa
Antonius Ziekenhuis
🇳🇱Sneek, Netherlands
Suite 209A Jakaranda Hospital
🇿🇦Pretoria, South Africa
DermMEDICA Sp. z o.o.
🇵🇱Wroclaw, Poland
Emmed Research
🇿🇦Muckleneuk, South Africa
Winelands Medical Research Centre
🇿🇦Stellenbosch, Western Cape, South Africa
Prof Ally
🇿🇦Pretoria, South Africa
Hospital Marina Baixa
🇪🇸La Vila Joiosa, Alicante, Spain
Hospital Infanta Luisa
🇪🇸Sevilla, Spain
Regional Clinical Hospital Center for Emergency medical care
🇺🇦Kharkiv, Ukraine
Hospital Del Sagrado Coraz
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
🇪🇸La Coruna, Spain
Kyiv City Clinical Hospital #3
🇺🇦Kyiv, Ukraine
Multifield Medical Center of Odesa NMU (University Clinic#1)
🇺🇦Odesa, Ukraine
Municipal Institution of Ternopil Regional Council
🇺🇦Ternopil, Ukraine
Vinnytsya Regional Clinical Hospital
🇺🇦Vinnytsya, Ukraine
Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna
🇸🇪Stockholm, Sweden
Southampton General Hospital
🇬🇧Southampton, Hants, United Kingdom
National Scientific Center "Strazhesko institute of cardio"
🇺🇦Kyiv, Ukraine
Regional Clinical Hospital of Zaporizhzhia
🇺🇦Zaporizhzhia, Ukraine
The Great Western Hospital
🇬🇧Swindon, Wiltshire, United Kingdom
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Wythenshawe Hospital
🇬🇧Wythenshawe, Manchester, United Kingdom
St Lukes Hospital
🇬🇧Bradford, West Yorkshire, United Kingdom
The Dudley Group NHS Foundation Trust
🇬🇧Dudley, West Midlands, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
Reumatologikliniken Västmanlands Sjukhus
🇸🇪Västerås, Västmanland, Sweden
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Policlinico di Tor Vergata
🇮🇹Roma, Italy
Ospedale Policlinico Giambattista Rossi, Borgo Roma
🇮🇹Verona, Italy
North Tyneside General Hospital
🇬🇧North Shields, Tyneside, United Kingdom
Centre de Recherche Musculo-Squelettique
🇨🇦Trois-Rivieres, Quebec, Canada
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
🇩🇪Frankfurt am Main, Hessen, Germany
Consultora Integral de Salud S.R.L.
🇦🇷Cordoba, Argentina
Centro Medico Privado de Reumatologia
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Centro de Medicina Familiar Mindout Research
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Reumatologiska Kliniken Skånes universitetssjukhus Malmö
🇸🇪Malmo, Sweden
Centrum för reumatologi
🇸🇪Stockholm, Sweden
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, La Coruna, Spain
HUG-Hôpitaux Universitaires de Genève
🇨🇭Genève, Switzerland
Polmed Research Inc.
🇨🇦Saskatoon, Saskatchewan, Canada