Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03151551
Registration number
NCT03151551
Ethics application status
Date submitted
4/05/2017
Date registered
12/05/2017
Titles & IDs
Public title
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
I1F-MC-RHCF
Query!
Secondary ID [2]
0
0
16687
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SPIRIT-H2H
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ixekizumab
Treatment: Drugs - Adalimumab
Experimental: 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.
Active comparator: 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.
Treatment: Drugs: Ixekizumab
Administered SC
Treatment: Drugs: Adalimumab
Administered SC
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving ACR50
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving PASI100
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 24
Query!
Eligibility
Key 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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/08/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
4/09/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
566
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Combined Rheumatology Practice (CRP) - Kogarah
Query!
Recruitment hospital [2]
0
0
Rheumatology, The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [3]
0
0
Southern Clinical Research Pty Ltd - Hobart
Query!
Recruitment hospital [4]
0
0
Emeritus Research - Camberwell
Query!
Recruitment hospital [5]
0
0
St Vincents Hospital Melbourne - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [3]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [4]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [5]
0
0
3065 - Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Tucuman
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Ciudad Autonoma de Buenos Aire
Query!
Country [4]
0
0
Argentina
Query!
State/province [4]
0
0
Cordoba
Query!
Country [5]
0
0
Argentina
Query!
State/province [5]
0
0
San Juan
Query!
Country [6]
0
0
Austria
Query!
State/province [6]
0
0
Wien
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Genk
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Gent
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Gilly
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Leuven
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Mons
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Ontario
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Quebec
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Saskatchewan
Query!
Country [15]
0
0
Denmark
Query!
State/province [15]
0
0
Hovedstaden
Query!
Country [16]
0
0
Denmark
Query!
State/province [16]
0
0
Aalborg
Query!
Country [17]
0
0
Finland
Query!
State/province [17]
0
0
Helsinki
Query!
Country [18]
0
0
Finland
Query!
State/province [18]
0
0
Hyvinkaa
Query!
Country [19]
0
0
Finland
Query!
State/province [19]
0
0
Kouvola
Query!
Country [20]
0
0
Finland
Query!
State/province [20]
0
0
Turku
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Chambray-lès-Tours
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
La Roche Sur Yon
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Lyon Cedex 03
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Montpellier Cedex 5
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Orleans CEDEX 2
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Toulouse cedex 9
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Bayern
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Hessen
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Nordrhein-Westfalen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hamburg
Query!
Country [31]
0
0
Hungary
Query!
State/province [31]
0
0
Jasz-Nagykun-Szolnok
Query!
Country [32]
0
0
Hungary
Query!
State/province [32]
0
0
Budapest
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Veszprem
Query!
Country [34]
0
0
India
Query!
State/province [34]
0
0
Andhra Pradesh
Query!
Country [35]
0
0
India
Query!
State/province [35]
0
0
Delhi
Query!
Country [36]
0
0
India
Query!
State/province [36]
0
0
Gujarat
Query!
Country [37]
0
0
India
Query!
State/province [37]
0
0
Haryana
Query!
Country [38]
0
0
India
Query!
State/province [38]
0
0
Karnataka
Query!
Country [39]
0
0
India
Query!
State/province [39]
0
0
Maharashtra
Query!
Country [40]
0
0
India
Query!
State/province [40]
0
0
Telengana
Query!
Country [41]
0
0
India
Query!
State/province [41]
0
0
West Bengal
Query!
Country [42]
0
0
Israel
Query!
State/province [42]
0
0
Ashkelon
Query!
Country [43]
0
0
Israel
Query!
State/province [43]
0
0
Haifa
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Kfar Saba
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Petach Tikva
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Ramat Gan
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Tel Aviv
Query!
Country [48]
0
0
Israel
Query!
State/province [48]
0
0
Zerifin
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Milano
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Bologna
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Catania
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Chieti
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Roma
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Verona
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
Baja California
Query!
Country [56]
0
0
Mexico
Query!
State/province [56]
0
0
Coahuila
Query!
Country [57]
0
0
Mexico
Query!
State/province [57]
0
0
Distrito Federal
Query!
Country [58]
0
0
Mexico
Query!
State/province [58]
0
0
Michoacan
Query!
Country [59]
0
0
Mexico
Query!
State/province [59]
0
0
Sinaloa
Query!
Country [60]
0
0
Mexico
Query!
State/province [60]
0
0
Yucatán
Query!
Country [61]
0
0
Netherlands
Query!
State/province [61]
0
0
Sneek
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Elblag
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Lodz
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Nowa Sol
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Warsaw
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Wroclaw
Query!
Country [67]
0
0
South Africa
Query!
State/province [67]
0
0
Eastern Cape
Query!
Country [68]
0
0
South Africa
Query!
State/province [68]
0
0
Gauteng
Query!
Country [69]
0
0
South Africa
Query!
State/province [69]
0
0
KwaZulu-Natal
Query!
Country [70]
0
0
South Africa
Query!
State/province [70]
0
0
Western Cape
Query!
Country [71]
0
0
South Africa
Query!
State/province [71]
0
0
Durban
Query!
Country [72]
0
0
South Africa
Query!
State/province [72]
0
0
Muckleneuk
Query!
Country [73]
0
0
South Africa
Query!
State/province [73]
0
0
Pretoria
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Alicante
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
La Coruna
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Barcelona
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Sevilla
Query!
Country [78]
0
0
Sweden
Query!
State/province [78]
0
0
Västmanland
Query!
Country [79]
0
0
Sweden
Query!
State/province [79]
0
0
Malmo
Query!
Country [80]
0
0
Sweden
Query!
State/province [80]
0
0
Stockholm
Query!
Country [81]
0
0
Switzerland
Query!
State/province [81]
0
0
Sankt Gallen
Query!
Country [82]
0
0
Switzerland
Query!
State/province [82]
0
0
Genève
Query!
Country [83]
0
0
Ukraine
Query!
State/province [83]
0
0
Kharkiv
Query!
Country [84]
0
0
Ukraine
Query!
State/province [84]
0
0
Kyiv
Query!
Country [85]
0
0
Ukraine
Query!
State/province [85]
0
0
Odesa
Query!
Country [86]
0
0
Ukraine
Query!
State/province [86]
0
0
Ternopil
Query!
Country [87]
0
0
Ukraine
Query!
State/province [87]
0
0
Vinnytsya
Query!
Country [88]
0
0
Ukraine
Query!
State/province [88]
0
0
Zaporizhzhia
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Cambridgeshire
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Cornwall
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Hants
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Manchester
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
North Lanarkshire
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Scotland
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Surrey
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Tyneside
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
West Midlands
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
West Yorkshire
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Wiltshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03151551
Query!
Trial related presentations / publications
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. 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. 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
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.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/51/NCT03151551/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/51/NCT03151551/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03151551