A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
SPIRIT-H2H
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
3 other identifiers
interventional
566
21 countries
128
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2017
Typical duration for phase_4
128 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 12, 2017
CompletedStudy Start
First participant enrolled
August 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2018
CompletedResults Posted
Study results publicly available
April 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2019
CompletedNovember 3, 2020
September 1, 2019
1.2 years
May 4, 2017
February 22, 2019
October 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
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.
Week 24
Secondary Outcomes (2)
Percentage of Participants Achieving ACR50
Week 24
Percentage of Participants Achieving PASI100
Week 24
Other Outcomes (26)
Change From Baseline in Tender Joint Count (TJC)
Baseline, Week 52
Change From Baseline in Swollen Joint Count (SJC)
Baseline, Week 52
Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)
Baseline, Week 52
- +23 more other outcomes
Study Arms (2)
Ixekizumab
EXPERIMENTAL160 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.
Adalimumab
ACTIVE COMPARATOR80 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (131)
Atencion Integral en Reumatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426AAL, Argentina
Clinica Adventista de Belgrano
Ciudad de Buenos Aires, Buenos Aires, C1430EGF, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC, Argentina
Instituto de Asist Reumatologica Integral
San Fernando, Buenos Aires, B1646DBM, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Organizacion Medica de Investigacion - OMI
Ciudad Autonoma de Buenos Aire, C1015ABO, Argentina
Instituto Centenario
Ciudad Autonoma de Buenos Aire, C1204AAD, Argentina
Hospital Ramos Mejia
Ciudad Autonoma de Buenos Aire, C1221ADC, Argentina
Centro de Medicina Familiar Mindout Research
Ciudad Autonoma de Buenos Aire, C1417EYG, Argentina
CENUDIAB
Ciudad Autonoma de Buenos Aire, C1440AAD, Argentina
Consultora Integral de Salud S.R.L.
Córdoba, 5004, Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
San Juan, J5402DIL, Argentina
Combined Rheumatology Practice (CRP)
Kogarah, New South Wales, 2217, Australia
Rheumatology, The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Southern Clinical Research Pty Ltd
Hobart, Tasmania, 7000, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
Vienna, 1060, Austria
AKH
Vienna, 1090, Austria
Rheuma-Zentrum Wien Oberlaa
Vienna, 1100, Austria
Reumaclinic
Genk, 3600, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Saint Joseph Hospital
Gilly, 6060, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Hopital Ambroise Pare
Mons, 7000, Belgium
The Waterside Clinic
Barrie, Ontario, L4M 6L2, Canada
SKiN Center for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Polmed Research Inc.
Saskatoon, Saskatchewan, S7K 0H6, Canada
Group de recherche en maladies osseuses
Québec, G1V 3M7, Canada
Frederiksberg Hospital
Frederiksberg, Capital Region, 2000, Denmark
Aalborg Universitetshospital - Psykiatrien
Aalborg, 9000, Denmark
Helsinki University Hospital, HYKS
Helsinki, 00029, Finland
Kiljava Medical Research
Hyvinkää, 05800, Finland
Terveystalo Kouvola
Kouvola, 45100, Finland
Turun Yliopistollinen Keskussairaala
Turku, 20521, Finland
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, 37170, France
Centre Hospitalier de Vendee Les Oudairies
La Roche-sur-Yon, 85025, France
Hopital Edouard Herriot
Lyon, 69003, France
Centre hospitalier universitaire Lapeyronie
Montpellier, 34295, France
Nouvel Hôpital Orléans La Source
Orléans, 45067, France
Hôpital Pierre-Paul Riquet
Toulouse, 31059, France
Klinikum der Universität München
München, Bavaria, 80336, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Rheumazentrum Ratingen
Ratingen, North Rhine-Westphalia, 40878, Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, 20095, Germany
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
UNO Medical Trials Kft.
Budapest, 1135, Hungary
Vital Medical Center
Veszprém, 8200, Hungary
Care Hospital
Hyderabad, Andhra Pradesh, 500035, India
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002, India
Panchshil Hospital
Ahmedabad, Gujarat, 380005, India
Byramjee Jeejeebhoy Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016, India
Shalby Hospital
Ahmedabad, Gujarat, 532004, India
Government Medical College & Sir Sayajirao General Hospital
Vadodara, Gujarat, 390001, India
Artemis Hospital
Gurgaon, Haryana, 122001, India
Narayana Hrudayalaya Hospital
Bangalore, Karnataka, 560099, India
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
Mumbai, Maharashtra, 400053, India
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, 411001, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Krishna Institute of Medical Sciences Ltd.
Secunderabad, Telangana, 500003, India
Apollo Gleneagles Hospitals
Kolkata, West Bengal, 700054, India
Barzilai Medical Center
Ashkelon, 78278, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5266202, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Assaf Harofeh Medical Center
Ẕerifin, 6093000, Israel
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Presidio Ospedaliero Vittorio Emanuele
Catania, 95124, Italy
Fondazione Universitaria degli Studi G D'Annunzio
Chieti, 66100, Italy
Policlinico di Tor Vergata
Roma, 00133, Italy
Complesso Integrato Columbus
Roma, 00168, Italy
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, 37134, Italy
CIMAB S.A. de C.V.
Torreón, Coahuila, 27000, Mexico
Centro Medico del Angel S.C.
Mexicali, Estado de Baja California, 21100, Mexico
Ctro Inv en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, 21200, Mexico
Grupo Médico CAMINO S.C.
Mexico City, Mexico City, 03310, Mexico
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
Morelia, Michoacán, 58249, Mexico
Centro Investigacion de Tratam Innovadores de Sinaloa SC
Culiacán, Sinaloa, 80000, Mexico
Cemdeicy S.C.P.
Mérida, Yucatán, 97130, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, 3100, Mexico
Antonius Ziekenhuis
Sneek, 8601 ZK, Netherlands
NZOZ Centrum Reumatologiczne Ind. Prak.
Elblag, 82-300, Poland
"Dermed" Centrum Medyczne Sp. z o.o.
Lodz, 90-265, Poland
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sól, 67100, Poland
Rheuma Medicus Zakład Opieki Zdrowotnej
Warsaw, 02-118, Poland
DermMEDICA Sp. z o.o.
Wroclaw, 51-318, Poland
Greenacres Hospital
Port Elizabeth, Eastern Cape, 6045, South Africa
Clinresco Centres (Pt) Ltd
Johannesburg, Gauteng, 1619, South Africa
Suite 509 Umhlanga Netcare Medical Centre
Durban, KwaZulu-Natal, 4319, South Africa
Arthritis Clinical Research Trial Unit
Pinelands, Western Cape, 7405, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600, South Africa
St Augustines Hospital
Durban, 4001, South Africa
Emmed Research
Muckleneuk, 0135, South Africa
Prof Ally
Pretoria, 0002, South Africa
Suite 209A Jakaranda Hospital
Pretoria, 0002, South Africa
Hospital Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruna, 15706, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, 15006, Spain
Hospital Del Sagrado Coraz
Barcelona, 08029, Spain
Hospital Infanta Luisa
Seville, 41010, Spain
Reumatologikliniken Västmanlands Sjukhus
Västerås, Västmanland County, 72189, Sweden
Reumatologiska Kliniken Skånes universitetssjukhus Malmö
Malmo, 205 02, Sweden
Centrum för reumatologi
Stockholm, 102 35, Sweden
Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
HUG-Hôpitaux Universitaires de Genève
Geneva, 1206, Switzerland
Regional Clinical Hospital Center for Emergency medical care
Kharkiv, Ukraine
National Scientific Center "Strazhesko institute of cardio"
Kyiv, 03680, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, Ukraine
Multifield Medical Center of Odesa NMU (University Clinic#1)
Odesa, 65026, Ukraine
Municipal Institution of Ternopil Regional Council
Ternopil, 46002, Ukraine
Vinnytsya Regional Clinical Hospital
Vinnytsia, 21018, Ukraine
Regional Clinical Hospital of Zaporizhzhia
Zaporizhzhia, 69600, Ukraine
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
Southampton General Hospital
Southampton, Hants, SO16 6YD, United Kingdom
Wythenshawe Hospital
Wythenshawe, Manchester, M23 9LT, United Kingdom
Wishaw General Hospital
Wishaw, North Lanarkshire, ML2 0DP, United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 2XU, United Kingdom
Whipps Cross University Hospital
London, Surrey, E11 1NR, United Kingdom
North Tyneside General Hospital
North Shields, Tyneside, NE29 8NH, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, DY1 2HQ, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
St Lukes Hospital
Bradford, West Yorkshire, BD5 0NA, United Kingdom
The Great Western Hospital
Swindon, Wiltshire, SN3 6BB, United Kingdom
Related Publications (6)
Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials. Rheumatol Ther. 2025 Apr;12(2):381-395. doi: 10.1007/s40744-025-00748-8. Epub 2025 Feb 27.
PMID: 40014255DERIVEDKirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
PMID: 37400681DERIVEDDeodhar 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.
PMID: 35393269DERIVEDElewski 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.
PMID: 35279805DERIVEDSmolen 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.
PMID: 33200394DERIVEDSmolen 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.
PMID: 32660977DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2017
First Posted
May 12, 2017
Study Start
August 24, 2017
Primary Completion
November 15, 2018
Study Completion
September 4, 2019
Last Updated
November 3, 2020
Results First Posted
April 2, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.