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/show/NCT03151551




Registration number
NCT03151551
Ethics application status
Date submitted
4/05/2017
Date registered
12/05/2017
Date last updated
2/04/2019

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) - 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.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants Achieving ACR50 - 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).
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving PASI100 - 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.
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in TJC - TJC is determined by examination of 68 joint counts that are assessed for tenderness by pressure and joint manipulation on physical examination.
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Change From Baseline in SJC - SJC is determined by examination of 66 joint counts that are classified as either swollen or not swollen. Swelling is defined as palpable fluctuating synovitis of the joint.
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Change From Baseline in Participant's Assessment of Pain VAS - Participants are asked to assess his/her current level of arthritis pain by marking a vertical tick on a horizontal VAS with the left end marked as "no pain" and the right end marked "worst possible pain."
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Change From Baseline in Participant's Global Assessment of Disease Activity - The participant's overall assessment of his or her PsA activity is recorded using a horizontal VAS.
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Change From Baseline in Physician's Global Assessment of Disease Activity - The investigator, who must be a physician, is asked to give an overall assessment of the severity of the participant's current PsA activity using a horizontal VAS.
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change From Baseline in C-Reactive Protein (CRP) - CRP is the ACR Core Set laboratory measure of acute-phase reactant.
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Change From Baseline in HAQ-DI - HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.
Timepoint [9] 0 0
Baseline, Week 52
Secondary outcome [10] 0 0
Percentage of Participants Simultaneously Achieving ACR50 and PASI100 - Proportion of participants simultaneously achieving ACR50 and PASI100 will be derived from the number of participants who have achieved PASI100 and achieved ACR50 divided by the total number of participants.
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Change From Baseline in Disease Activity Score-CRP (DAS28-CRP) - The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.
Timepoint [11] 0 0
Baseline, Week 52
Secondary outcome [12] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) - MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC =1; SJC =1; psoriasis activity and severity index (PASI total score) =1 or BSA =3; participant pain VAS score of =15; participant global disease activity VAS score of =20; HAQ-DI score =0.5; and tender entheseal points =1.
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) - The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA.
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified) - The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected.
Timepoint [14] 0 0
Baseline, Week 52
Secondary outcome [15] 0 0
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline - The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left [R/L]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L).
Timepoint [15] 0 0
Baseline, Week 52
Secondary outcome [16] 0 0
Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline - The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)).
Timepoint [16] 0 0
Baseline, Week 52
Secondary outcome [17] 0 0
Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline - The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in circumference over the contra-lateral digit.
Timepoint [17] 0 0
Baseline, Week 52
Secondary outcome [18] 0 0
Change From Baseline in Psoriasis Body Surface Area (BSA) - The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb.
Timepoint [18] 0 0
Baseline, Week 52
Secondary outcome [19] 0 0
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline - The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
Timepoint [19] 0 0
Baseline, Week 52
Secondary outcome [20] 0 0
Change From Baseline in the Itch NRS - The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis is indicated by circling the number that best described the worst level of itching in the past 24 hours.
Timepoint [20] 0 0
Baseline, Week 52
Secondary outcome [21] 0 0
Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score - The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours.
Timepoint [21] 0 0
Baseline, Week 52
Secondary outcome [22] 0 0
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) - SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well-being.
Timepoint [22] 0 0
Baseline, Week 52
Secondary outcome [23] 0 0
Change From Baseline in SF-36: Mental Component Summary (MCS) - SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well-being.
Timepoint [23] 0 0
Baseline, Week 52
Secondary outcome [24] 0 0
Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) - The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Timepoint [24] 0 0
Baseline, Week 52
Secondary outcome [25] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score - DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Timepoint [25] 0 0
Baseline, Week 52
Secondary outcome [26] 0 0
Change From Baseline on the Treatment Satisfaction Questionnaire - The Treatment Satisfaction Questionnaire is a clinician-administered questionnaire which provides an assessment of the participant's opinion of the effectiveness, safety, and overall satisfaction of the study medication.
Timepoint [26] 0 0
Baseline, Week 52
Secondary outcome [27] 0 0
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) - The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period.
Timepoint [27] 0 0
Baseline, Week 52

Eligibility
Key inclusion criteria
- Presents with 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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Tucuman
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autonoma de Buenos Aire
Country [4] 0 0
Argentina
State/province [4] 0 0
Cordoba
Country [5] 0 0
Argentina
State/province [5] 0 0
San Juan
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Belgium
State/province [7] 0 0
Genk
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Gilly
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Mons
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Canada
State/province [14] 0 0
Saskatchewan
Country [15] 0 0
Denmark
State/province [15] 0 0
Hovedstaden
Country [16] 0 0
Denmark
State/province [16] 0 0
Aalborg
Country [17] 0 0
Finland
State/province [17] 0 0
Helsinki
Country [18] 0 0
Finland
State/province [18] 0 0
Hyvinkaa
Country [19] 0 0
Finland
State/province [19] 0 0
Kouvola
Country [20] 0 0
Finland
State/province [20] 0 0
Turku
Country [21] 0 0
France
State/province [21] 0 0
Chambray-lès-Tours
Country [22] 0 0
France
State/province [22] 0 0
La Roche Sur Yon
Country [23] 0 0
France
State/province [23] 0 0
Lyon Cedex 03
Country [24] 0 0
France
State/province [24] 0 0
Montpellier Cedex 5
Country [25] 0 0
France
State/province [25] 0 0
Orleans CEDEX 2
Country [26] 0 0
France
State/province [26] 0 0
Toulouse cedex 9
Country [27] 0 0
Germany
State/province [27] 0 0
Bayern
Country [28] 0 0
Germany
State/province [28] 0 0
Hessen
Country [29] 0 0
Germany
State/province [29] 0 0
Nordrhein-Westfalen
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Hungary
State/province [31] 0 0
Jasz-Nagykun-Szolnok
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Veszprem
Country [34] 0 0
India
State/province [34] 0 0
Andhra Pradesh
Country [35] 0 0
India
State/province [35] 0 0
Delhi
Country [36] 0 0
India
State/province [36] 0 0
Gujarat
Country [37] 0 0
India
State/province [37] 0 0
Haryana
Country [38] 0 0
India
State/province [38] 0 0
Karnataka
Country [39] 0 0
India
State/province [39] 0 0
Maharashtra
Country [40] 0 0
India
State/province [40] 0 0
Telengana
Country [41] 0 0
India
State/province [41] 0 0
West Bengal
Country [42] 0 0
Israel
State/province [42] 0 0
Ashkelon
Country [43] 0 0
Israel
State/province [43] 0 0
Haifa
Country [44] 0 0
Israel
State/province [44] 0 0
Kfar Saba
Country [45] 0 0
Israel
State/province [45] 0 0
Petach Tikva
Country [46] 0 0
Israel
State/province [46] 0 0
Ramat Gan
Country [47] 0 0
Israel
State/province [47] 0 0
Tel Aviv
Country [48] 0 0
Israel
State/province [48] 0 0
Zerifin
Country [49] 0 0
Italy
State/province [49] 0 0
Milano
Country [50] 0 0
Italy
State/province [50] 0 0
Bologna
Country [51] 0 0
Italy
State/province [51] 0 0
Catania
Country [52] 0 0
Italy
State/province [52] 0 0
Chieti
Country [53] 0 0
Italy
State/province [53] 0 0
Roma
Country [54] 0 0
Italy
State/province [54] 0 0
Verona
Country [55] 0 0
Mexico
State/province [55] 0 0
Baja California
Country [56] 0 0
Mexico
State/province [56] 0 0
Coahuila
Country [57] 0 0
Mexico
State/province [57] 0 0
Distrito Federal
Country [58] 0 0
Mexico
State/province [58] 0 0
Michoacan
Country [59] 0 0
Mexico
State/province [59] 0 0
Sinaloa
Country [60] 0 0
Mexico
State/province [60] 0 0
Yucatán
Country [61] 0 0
Netherlands
State/province [61] 0 0
Sneek
Country [62] 0 0
Poland
State/province [62] 0 0
Elblag
Country [63] 0 0
Poland
State/province [63] 0 0
Lodz
Country [64] 0 0
Poland
State/province [64] 0 0
Nowa Sol
Country [65] 0 0
Poland
State/province [65] 0 0
Warsaw
Country [66] 0 0
Poland
State/province [66] 0 0
Wroclaw
Country [67] 0 0
South Africa
State/province [67] 0 0
Eastern Cape
Country [68] 0 0
South Africa
State/province [68] 0 0
Gauteng
Country [69] 0 0
South Africa
State/province [69] 0 0
KwaZulu-Natal
Country [70] 0 0
South Africa
State/province [70] 0 0
Western Cape
Country [71] 0 0
South Africa
State/province [71] 0 0
Durban
Country [72] 0 0
South Africa
State/province [72] 0 0
Muckleneuk
Country [73] 0 0
South Africa
State/province [73] 0 0
Pretoria
Country [74] 0 0
Spain
State/province [74] 0 0
Alicante
Country [75] 0 0
Spain
State/province [75] 0 0
La Coruna
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
Sevilla
Country [78] 0 0
Sweden
State/province [78] 0 0
Västmanland
Country [79] 0 0
Sweden
State/province [79] 0 0
Malmo
Country [80] 0 0
Sweden
State/province [80] 0 0
Stockholm
Country [81] 0 0
Switzerland
State/province [81] 0 0
Sankt Gallen
Country [82] 0 0
Switzerland
State/province [82] 0 0
Genève
Country [83] 0 0
Ukraine
State/province [83] 0 0
Kharkiv
Country [84] 0 0
Ukraine
State/province [84] 0 0
Kyiv
Country [85] 0 0
Ukraine
State/province [85] 0 0
Odesa
Country [86] 0 0
Ukraine
State/province [86] 0 0
Ternopil
Country [87] 0 0
Ukraine
State/province [87] 0 0
Vinnytsya
Country [88] 0 0
Ukraine
State/province [88] 0 0
Zaporizhzhia
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Cambridgeshire
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Cornwall
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Hants
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Manchester
Country [93] 0 0
United Kingdom
State/province [93] 0 0
North Lanarkshire
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Scotland
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Surrey
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Tyneside
Country [97] 0 0
United Kingdom
State/province [97] 0 0
West Midlands
Country [98] 0 0
United Kingdom
State/province [98] 0 0
West Yorkshire
Country [99] 0 0
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
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 website
https://clinicaltrials.gov/show/NCT03151551
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

Summary results
Other publications