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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
Date last updated
3/11/2020
Titles & IDs
Public title
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
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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
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Secondary ID [1]
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I1F-MC-RHCF
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Secondary ID [2]
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16687
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Universal Trial Number (UTN)
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Trial acronym
SPIRIT-H2H
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percentage of Participants Achieving ACR50
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Assessment method [1]
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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).
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants Achieving PASI100
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Assessment method [2]
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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.
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Timepoint [2]
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Week 24
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/08/2017
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
4/09/2019
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Sample size
Target
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Accrual to date
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Final
566
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
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Recruitment hospital [1]
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Combined Rheumatology Practice (CRP) - Kogarah
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Rheumatology, The Queen Elizabeth Hospital - Woodville South
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Southern Clinical Research Pty Ltd - Hobart
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Emeritus Research - Camberwell
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St Vincents Hospital Melbourne - Fitzroy
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2217 - Kogarah
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5011 - Woodville South
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7000 - Hobart
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3124 - Camberwell
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3065 - Fitzroy
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03151551
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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.
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Data sharing statement
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
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