Clinical trial NCT03151551: A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
Official title: A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriatic Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-05-12
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving ACR50
timeFrame: Week 24
measure: Percentage of Participants Achieving PASI100
timeFrame: Week 24
Other outcomes:
measure: Change From Baseline in Tender Joint Count (TJC)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Swollen Joint Count (SJC)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Participant's Global Assessment of Disease Activity
timeFrame: Baseline, Week 52
measure: Change From Baseline in Physician's Global Assessment of Disease Activity
timeFrame: Baseline, Week 52
measure: Change From Baseline in C-Reactive Protein (CRP)
timeFrame: Baseline, Week 52
measure: Change From Baseline in HAQ-DI
timeFrame: Baseline, Week 52
measure: Percentage of Participants Simultaneously Achieving ACR50 and PASI100
timeFrame: Week 52
measure: Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA)
timeFrame: Week 52
measure: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
timeFrame: Week 52
measure: Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline
timeFrame: Baseline, Week 52
measure: Change From Baseline in Psoriasis Body Surface Area (BSA)
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Itch NRS
timeFrame: Baseline, Week 52
measure: Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)
timeFrame: Baseline, Week 52
measure: Change From Baseline in SF-36: Mental Component Summary (MCS)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline, Week 52
measure: Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)
timeFrame: Week 52
measure: Number of Participants Who Answered "Yes" to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Week 52
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Atencion Integral en Reumatología
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Clinica Adventista de Belgrano
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER Instituto Medico
state: Buenos Aires
city: San Fernando
country: Argentina
facility: Instituto de Asist Reumatologica Integral
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Organizacion Medica de Investigacion - OMI
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto Centenario
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Ramos Mejia
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro de Medicina Familiar Mindout Research
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: CENUDIAB
city: Cordoba
country: Argentina
facility: Consultora Integral de Salud S.R.L.
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
city: Kogarah
country: Australia
facility: Combined Rheumatology Practice (CRP)
state: New South Wales
city: Woodville South
country: Australia
facility: Rheumatology, The Queen Elizabeth Hospital
state: South Australia
city: Hobart
country: Australia
facility: Southern Clinical Research Pty Ltd
state: Tasmania
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
state: Victoria
city: Wien
country: Austria
facility: Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
city: Wien
country: Austria
facility: AKH
city: Wien
country: Austria
facility: Rheuma-Zentrum Wien Oberlaa
city: Genk
country: Belgium
facility: Reumaclinic
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Gilly
country: Belgium
facility: Saint Joseph Hospital
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Mons
country: Belgium
facility: Hopital Ambroise Pare
city: Barrie
country: Canada
facility: The Waterside Clinic
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Center for Dermatology
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Saskatoon
country: Canada
facility: Polmed Research Inc.
state: Saskatchewan
city: Quebec
country: Canada
facility: Group de recherche en maladies osseuses
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital - Psykiatrien
city: Helsinki
country: Finland
facility: Helsinki University Hospital, HYKS
city: Hyvinkaa
country: Finland
facility: Kiljava Medical Research
city: Kouvola
country: Finland
facility: Terveystalo Kouvola
city: Turku
country: Finland
facility: Turun Yliopistollinen Keskussairaala
city: Chambray-lès-Tours
country: France
facility: Hôpital Trousseau, CHRU de Tours
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier de Vendee Les Oudairies
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Montpellier Cedex 5
country: France
facility: Centre hospitalier universitaire Lapeyronie
city: Orleans CEDEX 2
country: France
facility: Nouvel Hôpital Orléans La Source
city: Toulouse cedex 9
country: France
facility: Hôpital Pierre-Paul Riquet
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hessen
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: HRF Hamburger Rheuma Forschungszentrum
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: UNO Medical Trials Kft.
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Hyderabad
country: India
facility: Care Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Panchshil Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Byramjee Jeejeebhoy Medical College & Civil Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Shalby Hospital
state: Gujarat
city: Vadodara
country: India
facility: Government Medical College & Sir Sayajirao General Hospital
state: Gujarat
city: Gurgaon
country: India
facility: Artemis Hospital
state: Haryana
city: Bangalore
country: India
facility: Narayana Hrudayalaya Hospital
state: Karnataka
city: Mumbai
country: India
facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic and Grant Medical Foundation
state: Maharashtra
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences Ltd.
state: Telengana
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals
state: West Bengal
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Catania
country: Italy
facility: Presidio Ospedaliero Vittorio Emanuele
city: Chieti
country: Italy
facility: Fondazione Universitaria degli Studi G D'Annunzio
city: Roma
country: Italy
facility: Policlinico di Tor Vergata
city: Roma
country: Italy
facility: Complesso Integrato Columbus
city: Verona
country: Italy
facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma
city: Mexicali
country: Mexico
facility: Centro Medico del Angel S.C.
state: Baja California
city: Mexicali
country: Mexico
facility: Ctro Inv en Artritis y Osteoporosis SC
state: Baja California
city: Torreon
country: Mexico
facility: CIMAB S.A. de C.V.
state: Coahuila
city: México City
country: Mexico
facility: Grupo Médico CAMINO S.C.
state: Distrito Federal
city: Morelia
country: Mexico
facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC
state: Michoacan
city: Culiacan
country: Mexico
facility: Centro Investigacion de Tratam Innovadores de Sinaloa SC
state: Sinaloa
city: Merida
country: Mexico
facility: Cemdeicy S.C.P.
state: Yucatán
city: Distrito Federal
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Elblag
country: Poland
facility: NZOZ Centrum Reumatologiczne Ind. Prak.
city: Lodz
country: Poland
facility: "Dermed" Centrum Medyczne Sp. z o.o.
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol
city: Warsaw
country: Poland
facility: Rheuma Medicus Zakład Opieki Zdrowotnej
city: Wroclaw
country: Poland
facility: DermMEDICA Sp. z o.o.
city: Port Elizabeth
country: South Africa
facility: Greenacres Hospital
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Clinresco Centres (Pt) Ltd
state: Gauteng
city: Durban
country: South Africa
facility: Suite 509 Umhlanga Netcare Medical Centre
state: KwaZulu-Natal
city: Pinelands
country: South Africa
facility: Arthritis Clinical Research Trial Unit
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre
state: Western Cape
city: Durban
country: South Africa
facility: St Augustines Hospital
city: Muckleneuk
country: South Africa
facility: Emmed Research
city: Pretoria
country: South Africa
facility: Prof Ally
city: Pretoria
country: South Africa
facility: Suite 209A Jakaranda Hospital
city: La Vila Joiosa
country: Spain
facility: Hospital Marina Baixa
state: Alicante
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: La Coruna
city: Barcelona
country: Spain
facility: Hospital Del Sagrado Coraz
city: La Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruña, CHUAC
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Västerås
country: Sweden
facility: Reumatologikliniken Västmanlands Sjukhus
state: Västmanland
city: Malmo
country: Sweden
facility: Reumatologiska Kliniken Skånes universitetssjukhus Malmö
city: Stockholm
country: Sweden
facility: Centrum för reumatologi
city: Stockholm
country: Sweden
facility: Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
state: Sankt Gallen
city: Genève
country: Switzerland
facility: HUG-Hôpitaux Universitaires de Genève
city: Kharkiv
country: Ukraine
facility: Regional Clinical Hospital Center for Emergency medical care
city: Kyiv
country: Ukraine
facility: National Scientific Center "Strazhesko institute of cardio"
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Odesa
country: Ukraine
facility: Multifield Medical Center of Odesa NMU (University Clinic#1)
city: Ternopil
country: Ukraine
facility: Municipal Institution of Ternopil Regional Council
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Regional Clinical Hospital
city: Zaporizhzhia
country: Ukraine
facility: Regional Clinical Hospital of Zaporizhzhia
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hants
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hospital
state: Manchester
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
state: North Lanarkshire
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Surrey
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: Tyneside
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: West Midlands
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: West Midlands
city: Bradford
country: United Kingdom
facility: St Lukes Hospital
state: West Yorkshire
city: Swindon
country: United Kingdom
facility: The Great Western Hospital
state: Wiltshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.
citation: Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
citation: Smolen JS, Sebba A, Ruderman EM, Schulze-Koops H, Sapin C, Gellett AM, Sprabery AT, Li L, de la Torre I, Gallo G, Liu-Leage S, Pillai S, Reis P, Nash P. Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naive Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study. Rheumatol Ther. 2020 Dec;7(4):1021-1035. doi: 10.1007/s40744-020-00250-3. Epub 2020 Nov 16.
citation: Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Gratacos J, Goupille P, Liu Leage S, Pillai S, Nash P. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naive to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020 Oct;79(10):1310-1319. doi: 10.1136/annrheumdis-2020-217372. Epub 2020 Jul 13.