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A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (SPIRIT-H2H)

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ixekizumab
Adalimumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

Sites / Locations

  • Atencion Integral en Reumatología
  • Clinica Adventista de Belgrano
  • CER Instituto Medico
  • Instituto de Asist Reumatologica Integral
  • Centro Medico Privado de Reumatologia
  • Organizacion Medica de Investigacion - OMI
  • Instituto Centenario
  • Hospital Ramos Mejia
  • Centro de Medicina Familiar Mindout Research
  • CENUDIAB
  • Consultora Integral de Salud S.R.L.
  • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
  • Combined Rheumatology Practice (CRP)
  • Rheumatology, The Queen Elizabeth Hospital
  • Southern Clinical Research Pty Ltd
  • Emeritus Research
  • St Vincents Hospital Melbourne
  • Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
  • AKH
  • Rheuma-Zentrum Wien Oberlaa
  • Reumaclinic
  • Universitair Ziekenhuis Gent
  • Saint Joseph Hospital
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Hopital Ambroise Pare
  • The Waterside Clinic
  • SKiN Center for Dermatology
  • Centre de Recherche Musculo-Squelettique
  • Polmed Research Inc.
  • Group de recherche en maladies osseuses
  • Frederiksberg Hospital
  • Aalborg Universitetshospital - Psykiatrien
  • Helsinki University Hospital, HYKS
  • Kiljava Medical Research
  • Terveystalo Kouvola
  • Turun Yliopistollinen Keskussairaala
  • Hôpital Trousseau, CHRU de Tours
  • Centre Hospitalier de Vendee Les Oudairies
  • Hopital Edouard Herriot
  • Centre hospitalier universitaire Lapeyronie
  • Nouvel Hôpital Orléans La Source
  • Hôpital Pierre-Paul Riquet
  • Klinikum der Universität München
  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
  • Rheumazentrum Ratingen
  • HRF Hamburger Rheuma Forschungszentrum
  • Allergo-Derm Bakos Kft
  • Obudai Egeszsegugyi Centrum Kft
  • UNO Medical Trials Kft.
  • Vital Medical Center
  • Care Hospital
  • King George Hospital
  • Sir Ganga Ram Hospital
  • Panchshil Hospital
  • Byramjee Jeejeebhoy Medical College & Civil Hospital
  • Shalby Hospital
  • Government Medical College & Sir Sayajirao General Hospital
  • Artemis Hospital
  • Narayana Hrudayalaya Hospital
  • Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
  • Ruby Hall Clinic and Grant Medical Foundation
  • Krishna Institute of Medical Sciences Ltd.
  • Apollo Gleneagles Hospitals
  • Barzilai Medical Center
  • Rambam Medical Center
  • Carmel Medical Center
  • Meir Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Assaf Harofeh Medical Center
  • Istituto Clinico Humanitas
  • Istituto Ortopedico Rizzoli
  • Presidio Ospedaliero Vittorio Emanuele
  • Fondazione Universitaria degli Studi G D'Annunzio
  • Policlinico di Tor Vergata
  • Complesso Integrato Columbus
  • Ospedale Policlinico Giambattista Rossi, Borgo Roma
  • Centro Medico del Angel S.C.
  • Ctro Inv en Artritis y Osteoporosis SC
  • CIMAB S.A. de C.V.
  • Grupo Médico CAMINO S.C.
  • Clínica Enfermedades Crónicas y Procedimientos Especiales SC
  • Centro Investigacion de Tratam Innovadores de Sinaloa SC
  • Cemdeicy S.C.P.
  • RM Pharma Specialists S.A. de C.V.
  • Antonius Ziekenhuis
  • NZOZ Centrum Reumatologiczne Ind. Prak.
  • "Dermed" Centrum Medyczne Sp. z o.o.
  • Twoja Przychodnia-Centrum Medyczne Nowa Sol
  • Rheuma Medicus Zakład Opieki Zdrowotnej
  • DermMEDICA Sp. z o.o.
  • Greenacres Hospital
  • Clinresco Centres (Pt) Ltd
  • Suite 509 Umhlanga Netcare Medical Centre
  • Arthritis Clinical Research Trial Unit
  • Winelands Medical Research Centre
  • St Augustines Hospital
  • Emmed Research
  • Prof Ally
  • Suite 209A Jakaranda Hospital
  • Hospital Marina Baixa
  • Hospital Clinico Universitario de Santiago
  • Hospital Del Sagrado Coraz
  • Complexo Hospitalario Universitario A Coruña, CHUAC
  • Hospital Infanta Luisa
  • Reumatologikliniken Västmanlands Sjukhus
  • Reumatologiska Kliniken Skånes universitetssjukhus Malmö
  • Centrum för reumatologi
  • Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna
  • Kantonsspital St. Gallen
  • HUG-Hôpitaux Universitaires de Genève
  • Regional Clinical Hospital Center for Emergency medical care
  • National Scientific Center "Strazhesko institute of cardio"
  • Kyiv City Clinical Hospital #3
  • Multifield Medical Center of Odesa NMU (University Clinic#1)
  • Municipal Institution of Ternopil Regional Council
  • Vinnytsya Regional Clinical Hospital
  • Regional Clinical Hospital of Zaporizhzhia
  • Addenbrookes Hospital
  • Royal Cornwall Hospital
  • Southampton General Hospital
  • Wythenshawe Hospital
  • Wishaw General Hospital
  • Western General Hospital
  • Whipps Cross University Hospital
  • North Tyneside General Hospital
  • The Dudley Group NHS Foundation Trust
  • New Cross Hospital
  • St Lukes Hospital
  • The Great Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ixekizumab

Adalimumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
May 4, 2017
Last Updated
October 9, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03151551
Brief Title
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis
Acronym
SPIRIT-H2H
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
September 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
566 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ixekizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab
Other Intervention Name(s)
LY2439821
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving ACR50
Description
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).
Time Frame
Week 24
Title
Percentage of Participants Achieving PASI100
Description
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.
Time Frame
Week 24
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Tender Joint Count (TJC)
Description
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Swollen Joint Count (SJC)
Description
SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)
Description
The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Participant's Global Assessment of Disease Activity
Description
The patient's overall assessment of his or her PsA activity was recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Physician's Global Assessment of Disease Activity
Description
The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in C-Reactive Protein (CRP)
Description
CRP is the ACR Core Set laboratory measure of acute-phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on the participant's PsA. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in HAQ-DI
Description
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. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Percentage of Participants Simultaneously Achieving ACR50 and PASI100
Description
ACR50 response is a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of VAS, Pts Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, participant assessment of physical function using the 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. Participant achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. 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 52.
Time Frame
Week 52
Title
Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
Description
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. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Percentage of Participants Achieving Minimal Disease Activity (MDA)
Description
MDA is a composite of 7 key outcome measures: 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. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures.
Time Frame
Week 52
Title
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Description
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.
Time Frame
Week 52
Title
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score
Description
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. Each domain with the exception of spinal disease is scored from 0-3. Individual domain scores are summed to give an overall composite score (range 0-12) with a higher score indicating higher disease activity. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline
Description
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). Tenderness at each site is quantified on a dichotomous basis: 0 = nontender and 1 = tender. The results from each site are then added to produce a total score (range 0 to 16) with the Higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline
Description
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)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline
Description
The LDI-B measures the severity of dactylitis.In each digit,the ratio of the circumference(cf) of the affected digit to the cf of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in cf over the contra-lateral digit.If the same digits on each hand or foot were thought to be involved,the clinician referred to a table of normative values for a value which was used to provide the comparison.If the ratio is >1.1,then subtract 1 from the calculated ratio and multiply it by 100 and the tenderness score of 0(not tender) or 1(tender).Otherwise,if the ratio of the cf of the digit is ≤1.1,then the LDI-B score is set to 0.LDI-B score can be >=0 with higher numbers indicating worse dactylitis.LS mean was calculated using MMRM model: treatment group,concomitant csDMARD use at baseline,moderate-to-severe Ps involvement,visit as fixed factors,baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Psoriasis Body Surface Area (BSA)
Description
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. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline
Description
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). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in the Itch NRS
Description
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. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score
Description
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. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)
Description
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in SF-36: Mental Component Summary (MCS)
Description
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score
Description
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. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The descriptive part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension.This produced participant-level index scores between -0.594 and 1.0 (worse to better health). LS mean was calculated using MMRM model that included treatment group,concomitant csDMARD use at baseline,moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score
Description
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 0 (worst health you can imagine) to 100mm VAS (best health you can imagine). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Description
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.
Time Frame
Baseline, Week 52
Title
Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)
Description
The TSQ is a clinician-administered questionnaire that provides an assessment of the patient's opinion of the effectiveness, safety, and overall satisfaction of the study medication. Participants were asked to respond to questionnaire items using a 4-point Likert scale (from "mostly satisfied" to "mostly dissatisfied").
Time Frame
Week 52
Title
Number of Participants Who Answered "Yes" to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period. Wish to be dead Non-specific active suicidal thoughts Active suicidal ideation with any methods (not plan) without intent to act Active suicidal ideation with some intent to act, without specific plan Active suicidal ideation with specific plan and intent Preparatory acts or behavior Aborted attempt Interrupted attempt Non-fatal suicide attempt Completed suicide
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Atencion Integral en Reumatología
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1426AAL
Country
Argentina
Facility Name
Clinica Adventista de Belgrano
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
CER Instituto Medico
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVC
Country
Argentina
Facility Name
Instituto de Asist Reumatologica Integral
City
San Fernando
State/Province
Buenos Aires
ZIP/Postal Code
B1646DBM
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Organizacion Medica de Investigacion - OMI
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Instituto Centenario
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1204AAD
Country
Argentina
Facility Name
Hospital Ramos Mejia
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Centro de Medicina Familiar Mindout Research
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1417EYG
Country
Argentina
Facility Name
CENUDIAB
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1440AAD
Country
Argentina
Facility Name
Consultora Integral de Salud S.R.L.
City
Cordoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
Combined Rheumatology Practice (CRP)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Rheumatology, The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Southern Clinical Research Pty Ltd
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Zentrum für klinische Studien Dr. Ursula Hanusch GmbH
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
AKH
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Rheuma-Zentrum Wien Oberlaa
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Reumaclinic
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Saint Joseph Hospital
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hopital Ambroise Pare
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
The Waterside Clinic
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
SKiN Center for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Polmed Research Inc.
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Group de recherche en maladies osseuses
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Frederiksberg Hospital
City
Frederiksberg
State/Province
Hovedstaden
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Aalborg Universitetshospital - Psykiatrien
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Helsinki University Hospital, HYKS
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Kiljava Medical Research
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
Terveystalo Kouvola
City
Kouvola
ZIP/Postal Code
45100
Country
Finland
Facility Name
Turun Yliopistollinen Keskussairaala
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Hôpital Trousseau, CHRU de Tours
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Centre Hospitalier de Vendee Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon Cedex 03
ZIP/Postal Code
69003
Country
France
Facility Name
Centre hospitalier universitaire Lapeyronie
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Nouvel Hôpital Orléans La Source
City
Orleans CEDEX 2
ZIP/Postal Code
45067
Country
France
Facility Name
Hôpital Pierre-Paul Riquet
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Klinikum der Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Rheumazentrum Ratingen
City
Ratingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40878
Country
Germany
Facility Name
HRF Hamburger Rheuma Forschungszentrum
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Allergo-Derm Bakos Kft
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Vital Medical Center
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Care Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500035
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Panchshil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380005
Country
India
Facility Name
Byramjee Jeejeebhoy Medical College & Civil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380016
Country
India
Facility Name
Shalby Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
532004
Country
India
Facility Name
Government Medical College & Sir Sayajirao General Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
Artemis Hospital
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Narayana Hrudayalaya Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Facility Name
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400053
Country
India
Facility Name
Ruby Hall Clinic and Grant Medical Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Krishna Institute of Medical Sciences Ltd.
City
Secunderabad
State/Province
Telengana
ZIP/Postal Code
500003
Country
India
Facility Name
Apollo Gleneagles Hospitals
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
6093000
Country
Israel
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Presidio Ospedaliero Vittorio Emanuele
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Fondazione Universitaria degli Studi G D'Annunzio
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Policlinico di Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Complesso Integrato Columbus
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale Policlinico Giambattista Rossi, Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Centro Medico del Angel S.C.
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Ctro Inv en Artritis y Osteoporosis SC
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Facility Name
CIMAB S.A. de C.V.
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Grupo Médico CAMINO S.C.
City
México City
State/Province
Distrito Federal
ZIP/Postal Code
03310
Country
Mexico
Facility Name
Clínica Enfermedades Crónicas y Procedimientos Especiales SC
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58249
Country
Mexico
Facility Name
Centro Investigacion de Tratam Innovadores de Sinaloa SC
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Facility Name
Cemdeicy S.C.P.
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
Facility Name
RM Pharma Specialists S.A. de C.V.
City
Distrito Federal
ZIP/Postal Code
3100
Country
Mexico
Facility Name
Antonius Ziekenhuis
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
NZOZ Centrum Reumatologiczne Ind. Prak.
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
"Dermed" Centrum Medyczne Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
Twoja Przychodnia-Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67100
Country
Poland
Facility Name
Rheuma Medicus Zakład Opieki Zdrowotnej
City
Warsaw
ZIP/Postal Code
02-118
Country
Poland
Facility Name
DermMEDICA Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Facility Name
Greenacres Hospital
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Clinresco Centres (Pt) Ltd
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Suite 509 Umhlanga Netcare Medical Centre
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4319
Country
South Africa
Facility Name
Arthritis Clinical Research Trial Unit
City
Pinelands
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Winelands Medical Research Centre
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
St Augustines Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Emmed Research
City
Muckleneuk
ZIP/Postal Code
0135
Country
South Africa
Facility Name
Prof Ally
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Suite 209A Jakaranda Hospital
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital Marina Baixa
City
La Vila Joiosa
State/Province
Alicante
ZIP/Postal Code
03570
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Del Sagrado Coraz
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña, CHUAC
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Reumatologikliniken Västmanlands Sjukhus
City
Västerås
State/Province
Västmanland
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Reumatologiska Kliniken Skånes universitetssjukhus Malmö
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Centrum för reumatologi
City
Stockholm
ZIP/Postal Code
102 35
Country
Sweden
Facility Name
Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
HUG-Hôpitaux Universitaires de Genève
City
Genève
ZIP/Postal Code
1206
Country
Switzerland
Facility Name
Regional Clinical Hospital Center for Emergency medical care
City
Kharkiv
Country
Ukraine
Facility Name
National Scientific Center "Strazhesko institute of cardio"
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #3
City
Kyiv
Country
Ukraine
Facility Name
Multifield Medical Center of Odesa NMU (University Clinic#1)
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Municipal Institution of Ternopil Regional Council
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Hospital
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Regional Clinical Hospital of Zaporizhzhia
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Addenbrookes Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hants
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
State/Province
North Lanarkshire
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Surrey
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
Tyneside
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
The Dudley Group NHS Foundation Trust
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
St Lukes Hospital
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
The Great Western Hospital
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN3 6BB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
35393269
Citation
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.
Results Reference
derived
PubMed Identifier
35279805
Citation
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.
Results Reference
derived
PubMed Identifier
33200394
Citation
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.
Results Reference
derived
PubMed Identifier
32660977
Citation
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.
Results Reference
derived
Links:
URL
https://www.lillytrialguide.com/en-US/studies/psoriatic-arthritis/RHCF#?postal=
Description
A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (Spirit-H2H)

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A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

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