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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03151551
Other study ID # 16687
Secondary ID I1F-MC-RHCF2016-
Status Completed
Phase Phase 4
First received
Last updated
Start date August 24, 2017
Est. completion date September 4, 2019

Study information

Verified date September 2019
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 566
Est. completion date September 4, 2019
Est. primary completion date November 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ixekizumab
Administered SC
Adalimumab
Administered SC

Locations

Country Name City State
Argentina Atencion Integral en Reumatología Ciudad Autonoma de Buenos Aire Buenos Aires
Argentina Centro de Medicina Familiar Mindout Research Ciudad Autonoma de Buenos Aire
Argentina CENUDIAB Ciudad Autonoma de Buenos Aire
Argentina Hospital Ramos Mejia Ciudad Autonoma de Buenos Aire
Argentina Instituto Centenario Ciudad Autonoma de Buenos Aire
Argentina Organizacion Medica de Investigacion - OMI Ciudad Autonoma de Buenos Aire
Argentina Clinica Adventista de Belgrano Ciudad de Buenos Aires Buenos Aires
Argentina Consultora Integral de Salud S.R.L. Cordoba
Argentina CER Instituto Medico Quilmes Buenos Aires
Argentina Instituto de Asist Reumatologica Integral San Fernando Buenos Aires
Argentina Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan San Juan
Argentina Centro Medico Privado de Reumatologia San Miguel de Tucuman Tucuman
Australia Emeritus Research Camberwell Victoria
Australia St Vincents Hospital Melbourne Fitzroy Victoria
Australia Southern Clinical Research Pty Ltd Hobart Tasmania
Australia Combined Rheumatology Practice (CRP) Kogarah New South Wales
Australia Rheumatology, The Queen Elizabeth Hospital Woodville South South Australia
Austria AKH Wien
Austria Rheuma-Zentrum Wien Oberlaa Wien
Austria Zentrum für klinische Studien Dr. Ursula Hanusch GmbH Wien
Belgium Reumaclinic Genk
Belgium Universitair Ziekenhuis Gent Gent
Belgium Saint Joseph Hospital Gilly
Belgium Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven
Belgium Hopital Ambroise Pare Mons
Canada The Waterside Clinic Barrie Ontario
Canada SKiN Center for Dermatology Peterborough Ontario
Canada Group de recherche en maladies osseuses Quebec
Canada Polmed Research Inc. Saskatoon Saskatchewan
Canada Centre de Recherche Musculo-Squelettique Trois-Rivieres Quebec
Denmark Aalborg Universitetshospital - Psykiatrien Aalborg
Denmark Frederiksberg Hospital Frederiksberg Hovedstaden
Finland Helsinki University Hospital, HYKS Helsinki
Finland Kiljava Medical Research Hyvinkaa
Finland Terveystalo Kouvola Kouvola
Finland Turun Yliopistollinen Keskussairaala Turku
France Hôpital Trousseau, CHRU de Tours Chambray-lès-Tours
France Centre Hospitalier de Vendee Les Oudairies La Roche Sur Yon
France Hopital Edouard Herriot Lyon Cedex 03
France Centre hospitalier universitaire Lapeyronie Montpellier Cedex 5
France Nouvel Hôpital Orléans La Source Orleans CEDEX 2
France Hôpital Pierre-Paul Riquet Toulouse cedex 9
Germany Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hessen
Germany HRF Hamburger Rheuma Forschungszentrum Hamburg
Germany Klinikum der Universität München München Bayern
Germany Rheumazentrum Ratingen Ratingen Nordrhein-Westfalen
Hungary Obudai Egeszsegugyi Centrum Kft Budapest
Hungary UNO Medical Trials Kft. Budapest
Hungary Allergo-Derm Bakos Kft Szolnok Jasz-Nagykun-Szolnok
Hungary Vital Medical Center Veszprem
India Byramjee Jeejeebhoy Medical College & Civil Hospital Ahmedabad Gujarat
India Panchshil Hospital Ahmedabad Gujarat
India Shalby Hospital Ahmedabad Gujarat
India Narayana Hrudayalaya Hospital Bangalore Karnataka
India Artemis Hospital Gurgaon Haryana
India Care Hospital Hyderabad Andhra Pradesh
India Apollo Gleneagles Hospitals Kolkata West Bengal
India Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst. Mumbai Maharashtra
India Sir Ganga Ram Hospital New Delhi Delhi
India Ruby Hall Clinic and Grant Medical Foundation Pune Maharashtra
India Krishna Institute of Medical Sciences Ltd. Secunderabad Telengana
India Government Medical College & Sir Sayajirao General Hospital Vadodara Gujarat
India King George Hospital Visakhapatnam Andhra Pradesh
Israel Barzilai Medical Center Ashkelon
Israel Carmel Medical Center Haifa
Israel Rambam Medical Center Haifa
Israel Meir Medical Center Kfar Saba
Israel Rabin Medical Center Petach Tikva
Israel Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Israel Assaf Harofeh Medical Center Zerifin
Italy Istituto Ortopedico Rizzoli Bologna
Italy Presidio Ospedaliero Vittorio Emanuele Catania
Italy Fondazione Universitaria degli Studi G D'Annunzio Chieti
Italy Complesso Integrato Columbus Roma
Italy Policlinico di Tor Vergata Roma
Italy Istituto Clinico Humanitas Rozzano Milano
Italy Ospedale Policlinico Giambattista Rossi, Borgo Roma Verona
Mexico Centro Investigacion de Tratam Innovadores de Sinaloa SC Culiacan Sinaloa
Mexico RM Pharma Specialists S.A. de C.V. Distrito Federal
Mexico Cemdeicy S.C.P. Merida Yucatán
Mexico Centro Medico del Angel S.C. Mexicali Baja California
Mexico Ctro Inv en Artritis y Osteoporosis SC Mexicali Baja California
Mexico Grupo Médico CAMINO S.C. México City Distrito Federal
Mexico Clínica Enfermedades Crónicas y Procedimientos Especiales SC Morelia Michoacan
Mexico CIMAB S.A. de C.V. Torreon Coahuila
Netherlands Antonius Ziekenhuis Sneek
Poland NZOZ Centrum Reumatologiczne Ind. Prak. Elblag
Poland "Dermed" Centrum Medyczne Sp. z o.o. Lodz
Poland Twoja Przychodnia-Centrum Medyczne Nowa Sol Nowa Sol
Poland Rheuma Medicus Zaklad Opieki Zdrowotnej Warsaw
Poland DermMEDICA Sp. z o.o. Wroclaw
South Africa St Augustines Hospital Durban
South Africa Suite 509 Umhlanga Netcare Medical Centre Durban KwaZulu-Natal
South Africa Clinresco Centres (Pt) Ltd Johannesburg Gauteng
South Africa Emmed Research Muckleneuk
South Africa Arthritis Clinical Research Trial Unit Pinelands Western Cape
South Africa Greenacres Hospital Port Elizabeth Eastern Cape
South Africa Prof Ally Pretoria
South Africa Suite 209A Jakaranda Hospital Pretoria
South Africa Winelands Medical Research Centre Stellenbosch Western Cape
Spain Hospital Del Sagrado Coraz Barcelona
Spain Complexo Hospitalario Universitario A Coruña, CHUAC La Coruna
Spain Hospital Marina Baixa La Vila Joiosa Alicante
Spain Hospital Clinico Universitario de Santiago Santiago de Compostela La Coruna
Spain Hospital Infanta Luisa Sevilla
Sweden Reumatologiska Kliniken Skånes universitetssjukhus Malmö Malmo
Sweden Centrum för reumatologi Stockholm
Sweden Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna Stockholm
Sweden Reumatologikliniken Västmanlands Sjukhus Västerås Västmanland
Switzerland HUG-Hôpitaux Universitaires de Genève Genève
Switzerland Kantonsspital St. Gallen St. Gallen Sankt Gallen
Ukraine Regional Clinical Hospital Center for Emergency medical care Kharkiv
Ukraine Kyiv City Clinical Hospital #3 Kyiv
Ukraine National Scientific Center "Strazhesko institute of cardio" Kyiv
Ukraine Multifield Medical Center of Odesa NMU (University Clinic#1) Odesa
Ukraine Municipal Institution of Ternopil Regional Council Ternopil
Ukraine Vinnytsya Regional Clinical Hospital Vinnytsya
Ukraine Regional Clinical Hospital of Zaporizhzhia Zaporizhzhia
United Kingdom St Lukes Hospital Bradford West Yorkshire
United Kingdom Addenbrookes Hospital Cambridge Cambridgeshire
United Kingdom The Dudley Group NHS Foundation Trust Dudley West Midlands
United Kingdom Western General Hospital Edinburgh Scotland
United Kingdom Whipps Cross University Hospital London Surrey
United Kingdom North Tyneside General Hospital North Shields Tyneside
United Kingdom Southampton General Hospital Southampton Hants
United Kingdom The Great Western Hospital Swindon Wiltshire
United Kingdom Royal Cornwall Hospital Truro Cornwall
United Kingdom Wishaw General Hospital Wishaw North Lanarkshire
United Kingdom New Cross Hospital Wolverhampton West Midlands
United Kingdom Wythenshawe Hospital Wythenshawe Manchester

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  South Africa,  Spain,  Sweden,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Baseline in Tender Joint Count (TJC) 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. Baseline, Week 52
Other Change From Baseline in Swollen Joint Count (SJC) 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. Baseline, Week 52
Other Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS) 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. Baseline, Week 52
Other Change From Baseline in Participant's Global Assessment of Disease Activity 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. Baseline, Week 52
Other Change From Baseline in Physician's Global Assessment of Disease Activity 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. Baseline, Week 52
Other Change From Baseline in C-Reactive Protein (CRP) 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. Baseline, Week 52
Other 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. 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. Baseline, Week 52
Other Percentage of Participants Simultaneously Achieving ACR50 and PASI100 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. Week 52
Other 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. 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. Baseline, Week 52
Other Percentage of Participants Achieving Minimal Disease Activity (MDA) 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. Week 52
Other 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. Week 52
Other Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score 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. Baseline, Week 52
Other 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). 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. Baseline, Week 52
Other 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)). 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. Baseline, Week 52
Other 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(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. Baseline, Week 52
Other 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. 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. Baseline, Week 52
Other 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). 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. Baseline, Week 52
Other 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. 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. Baseline, Week 52
Other 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. 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. Baseline, Week 52
Other Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) 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. Baseline, Week 52
Other Change From Baseline in SF-36: Mental Component Summary (MCS) 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. Baseline, Week 52
Other Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score 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. Baseline, Week 52
Other Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score 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. Baseline, Week 52
Other Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score 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. Baseline, Week 52
Other Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ) 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"). Week 52
Other Number of Participants Who Answered "Yes" to Any 10 Questions 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.
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
Week 52
Primary 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. Week 24
Secondary 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). Week 24
Secondary 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. Week 24
See also
  Status Clinical Trial Phase
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