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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
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
Secondary ID [1] 0 0
I1F-MC-RHCF
Secondary ID [2] 0 0
16687
Universal Trial Number (UTN)
Trial acronym
SPIRIT-H2H
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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)
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants Achieving ACR50
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving PASI100
Timepoint [2] 0 0
Week 24

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/09/2019
Sample size
Target
Accrual to date
Final
566
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Combined Rheumatology Practice (CRP) - Kogarah
Recruitment hospital [2] 0 0
Rheumatology, The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [3] 0 0
Southern Clinical Research Pty Ltd - Hobart
Recruitment hospital [4] 0 0
Emeritus Research - Camberwell
Recruitment hospital [5] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Argentina
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Buenos Aires
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Argentina
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Tucuman
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Cordoba
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Argentina
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San Juan
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Austria
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Wien
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Gilly
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Belgium
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Leuven
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Belgium
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Mons
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Ontario
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Quebec
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Saskatchewan
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Denmark
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Hovedstaden
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Aalborg
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Finland
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Helsinki
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Hyvinkaa
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Finland
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Kouvola
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Finland
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Turku
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La Roche Sur Yon
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Lyon Cedex 03
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Orleans CEDEX 2
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Toulouse cedex 9
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Bayern
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Hessen
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Nordrhein-Westfalen
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Hamburg
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Jasz-Nagykun-Szolnok
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Budapest
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Delhi
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Haryana
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Maharashtra
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Telengana
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West Bengal
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Ashkelon
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Haifa
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Kfar Saba
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Petach Tikva
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Ramat Gan
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Tel Aviv
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Milano
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Bologna
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Catania
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Chieti
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Barcelona
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Malmo
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Stockholm
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Switzerland
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Genève
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Ukraine
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Kharkiv
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Kyiv
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Odesa
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Ternopil
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Vinnytsya
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Ukraine
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Zaporizhzhia
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United Kingdom
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Cambridgeshire
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Cornwall
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Hants
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Manchester
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North Lanarkshire
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Scotland
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Surrey
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United Kingdom
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Tyneside
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United Kingdom
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West Midlands
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United Kingdom
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West Yorkshire
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United Kingdom
State/province [99] 0 0
Wiltshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03151551