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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349295
Other study ID # 14310
Secondary ID I1F-MC-RHBE2011-
Status Completed
Phase Phase 3
First received
Last updated
Start date December 31, 2014
Est. completion date June 26, 2019

Study information

Verified date September 1, 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 how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.


Recruitment information / eligibility

Status Completed
Enrollment 363
Est. completion date June 26, 2019
Est. primary completion date September 9, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

- Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints

- Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)

- 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 been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)

- Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.

Exclusion Criteria:

- Current use of biologic agents for treatment of Ps or PsA

- Inadequate response to greater than 2 biologic DMARDs

- Current use of more than one cDMARDs

- Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA

- Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy

- Serious disorder or illness other than psoriatic arthritis

- Serious infection within the last 3 months

- Breastfeeding or nursing (lactating) women

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Administered SC
Ixekizumab 80 mg Q4W
Administered SC
Ixekizumab 80 mg Q2W
Administered SC

Locations

Country Name City State
Australia Emeritus Research Camberwell Victoria
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Coast Joint Care Maroochydore Queensland
Czechia CCBR Czech Prague, s.r.o. Praha
Czechia MEDICAL PLUS, s.r.o. Uherske Hradiste
Czechia PV-MEDICAL s.r.o. Revmatologicka ambulance Zlin
France Hôpital Trousseau, CHRU de Tours Chambray-lès-Tours
France CHU de Montpellier-Hopital Arnaud de Villeneuve Montpellier Cedex 5
France Chru De Nantes Hotel-Dieu Nantes Cedex 1
France Hopital Cochin Paris CEDEX 14
France Hopital Purpan Toulouse
France CHU Brabois Vandoeuvre Les Nancy
Germany Charité Universitätsmedizin Berlin Berlin
Germany Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum Dresden Sachsen
Germany Universitätsklinikum Carl Gustav Carus Dresden Sachsen
Germany Klinikum der Johann Wolfgang Goethe-Universität Frankfurt Frankfurt am Main Hessen
Germany HRF Hamburger Rheuma Forschungszentrum Hamburg
Germany Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg
Germany Rheumazentrum Ruhrgebiet Herne Nordrhein-Westfalen
Germany Universität Leipzig - Universitätsklinikum Leipzig Sachsen
Germany Universitätsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein
Germany Universitätsklinikum Würzburg Würzburg Bayern
Italy Istituto Ortopedico Gaetano Pini Milano
Italy Azienda Ospedaliera - Universitaria Pisana Pisa
Poland Malopolskie Centrum Medyczne S.C. Krakow
Poland Medica pro Familia Sp z o.o. S.K.A Krakow
Poland AI Centrum Medyczne Poznan
Poland Medica pro Familia Sp z o.o. S.K.A Warszawa
Poland Rheuma Medicus Zaklad Opieki Zdrowotnej Warszawa
Spain Hospital De Basurto Bilbao Vizcaya
Spain Hospital De Fuenlabrada Fuenlabrada Madrid
Spain Complexo Hospitalario Universitario A Coruña, CHUAC La Coruña
Spain Hospital Regional Universitario de Málaga Malaga
Spain Centro de Salud Mental Parc Tauli Sabadell Barcelona
Spain Hospital Universitario Marques De Valdecilla Santander Cantabria
Spain Hospital Infanta Luisa Sevilla Andalucia
Spain Hospital Universitario Nuestra Señora de Valme Sevilla
Taiwan Chang Gung Memorial Hospital - Kaohsiung Kaohsiung City (r.o.c)
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Chung Shan Medical University Hospital Taichung City
Taiwan Chi-Mei Hospital, Liouying Tainan City Yongkang Dist
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Memorial Hospital - Linkou Taoyuan City
United Kingdom Basildon and Thurrock University Hospital Basildon Essex
United Kingdom King George Hospital Goodmayes Essex
United Kingdom Princess Alexandra Hospital Harlow Essex
United Kingdom Chapel Allerton Hospital Leeds West Yorkshire
United Kingdom Whipps Cross University Hospital London Surrey
United Kingdom New Cross Hospital Wolverhampton West Midlands
United States The Center for Rheumatology Albany New York
United States Albuquerque Rehabilitation & Rheumatology, PC Albuquerque New Mexico
United States Austin Regional Clinic Austin Texas
United States Austin Rheumatology Research PA Austin Texas
United States Johns Hopkins Arthritis Center Baltimore Maryland
United States Rheumatology Associates PC Birmingham Alabama
United States Rheumatology Associates of South Florida Boca Raton Florida
United States Tufts Medical Center Boston Massachusetts
United States Weill Cornell Medical College Brooklyn New York
United States Physicians Clinic of Iowa Cedar Rapids Iowa
United States Arthritis and Osteoporosis Consultants of the Carolinas Charlotte North Carolina
United States DJL Clinical Research, PLLC Charlotte North Carolina
United States New Jersey Physicians Clifton New Jersey
United States Klein and Associates MD, PA Cumberland Maryland
United States Arthritis Care & Diagnostic Center P.A. Dallas Texas
United States STAT Research Dayton Ohio
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Rheumatology and Immunotherapy Center Franklin Wisconsin
United States Arizona Arthritis & Rheumatology Research Glendale Arizona
United States Klein and Associates MD, PA Hagerstown Maryland
United States PMG Research of Hickory, LLC Hickory North Carolina
United States Accurate Clinical Research Houston Texas
United States Houston Institute for Clinical Research Houston Texas
United States Pioneer Research Solutions Houston Texas
United States Diagnostic Rheumatology and Research Indianapolis Indiana
United States Glacier View Research Institute Kalispell Montana
United States Kadlec Clinic Rheumatology Kennewick Washington
United States University of California - San Diego La Jolla California
United States Purushotham & Akther Kotha MD Inc La Mesa California
United States Beals Institute PC Lansing Michigan
United States Accurate Clinical Research League City Texas
United States Bluegrass Community Research. Inc Lexington Kentucky
United States PMA Medical Specialists, LLC Limerick Pennsylvania
United States Physician Research Collaboration, LLC Lincoln Nebraska
United States Little Rock Diagnostic Clinic Little Rock Arkansas
United States Arthritis & Osteoporosis Associates LLP Lubbock Texas
United States Methodist Healthcare Memphis Tennessee
United States Ramesh C. Gupta MD Memphis Tennessee
United States Arizona Arthritis & Rheumatology Research, PLLC Mesa Arizona
United States Jeffrey Alper MD Research Naples Florida
United States Health Research Institute Oklahoma City Oklahoma
United States Arthritis & Osteoporosis Treatment Center, PA Orange Park Florida
United States Stanford University Hospital Palo Alto California
United States Arizona Arthritis & Rheumatology Research Phoenix Arizona
United States Oregon Health and Science University Portland Oregon
United States Allergy Asthma Immunology of Rochester, AAIR Research Ctr Rochester New York
United States Washington University School of Medicine Saint Louis Missouri
United States East Bay Rheumatology Medical Group San Leandro California
United States Swedish Medical Center Seattle Washington
United States Rheumatology Associates of Long Island Smithtown New York
United States Arthritis Northwest PLLC Spokane Washington
United States Atlantic Coastal Research Toms River New Jersey
United States North MS Medical Clinics, Inc. Tupelo Mississippi
United States Office: Dr Robin K Dore Tustin California
United States Arthritis, Rheumatic & Back Disease Associates Voorhees New Jersey
United States Heartland Research Associates Wichita Kansas
United States Clinical Research Center of Reading, LLC Wyomissing Pennsylvania
United States Pennsylvania Regional Center for Arthritis & Osteoarthritis Wyomissing Pennsylvania
United States Florida Medical Clinic PA Zephyrhills Florida

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  France,  Germany,  Italy,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20) ACR20 response is defined as a greater than or equal to (=) 20% 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 VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP). Week 24
Secondary Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score 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 degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn. Baseline, Week 24
Secondary Percentage of Participants Achieving ACR20 ACR20 response is defined as a =20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. Week 12
Secondary Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50) ACR50 response is defined as a =50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. Week 24
Secondary Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70) ACR70 response is defined as a =70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. Week 24
Secondary Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Week 12
Secondary Percentage of Patients Achieving Minimal Disease Activity (MDA) It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC =1, 2. SJC =1, 3. PASI total score =1 or BSA =3, 4. patient pain VAS score of =15, 5. patient global VAS score of =20, 6. HAQ-DI score =0.5, 7. tender entheseal points (6 entheseal points) =1. Week 24
Secondary Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI) The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here. Week 24
Secondary Change From Baseline in Itch Numeric Rating Scale (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 participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 12
Secondary 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. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary 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 analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in Participants Assessment of Pain Visual Analog Scale (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 analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in Patients Global Assessment of Disease Activity VAS The patient's overall assessment of his or her PsA activity will be 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 analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in Physicians Global Assessment of Disease Activity VAS The investigator will be 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 analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in C-Reactive Protein (CRP) C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary 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 mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) 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 analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in Fatigue Severity Numeric Rating Scale (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 rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: 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. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: 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. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. Baseline, Week 24
Secondary Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group. Week 24
Secondary Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported. All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Secondary Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively). All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Secondary Percentage of Participants Achieving ACR 20 ACR20 response is defined as a =20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. Week 52 and Week 156
Secondary Percentage of Participants Achieving ACR 50 ACR50 response is defined as a =50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. Week 52 and Week 156
Secondary Percentage of Participants Achieving ACR 70 ACR70 response is defined as a =70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. Week 52 and Week 156
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