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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02349295
Registration number
NCT02349295
Ethics application status
Date submitted
10/10/2014
Date registered
28/01/2015
Date last updated
1/07/2020
Titles & IDs
Public title
A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis
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Secondary ID [1]
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I1F-MC-RHBE
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Secondary ID [2]
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14310
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Universal Trial Number (UTN)
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Trial acronym
SPIRIT-P2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ixekizumab 80 mg Q4W
Treatment: Drugs - Ixekizumab 80 mg Q2W
Experimental: Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W) - Blinded Treatment Period (Week(wk) 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22, and 24.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Wks 16,18,20,22,24. Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q2W at week 0 and continued on ixe 80 mg Q2W during the Extension Period. Pts who received ixekizumab 80 mg Q2W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Experimental: Ixekizumab 80 mg Q4W - Blinded Treatment Period (Week 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q4W given on Wks 4, 8 and 12 alternating with placebo for ixe injections Q4W given on Wks 2,6,10,14,18, and 22.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Wks 16 and 20 alternating with placebo for ixe injections Q4W given on Wks 18 and 22.Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q4W at week 0 and continued on ixe 80 mg Q4W during the Extension Period.Pts who received ixekizumab 80 mg Q4W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Placebo Comparator: Placebo - Blinded Treatment Period (Wk 0-24): Pts received placebo for Ixe as 2 SC injections followed by 1 SC injection Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22 and 24. Pts initially randomized to placebo treatment group in the double blind treatment period,flagged as IR at Wk 16,re-randomized to ixe 80 mg Q2W/Q4W for the remainder of the current period and following period. Extended Treatment Period (Wk 24-156): Pts who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W/Q4W during the Extension Period.Pts who remained on placebo at the completion of the double blind treatment period received the first dose of ixe (160 mg starting dose) at Wk 24.Pts who were IRs at Wk 16 and were re-randomized to ixe at Wk 16 received the first dose of ixe (160 mg starting dose) at Wk 16. Pts who received placebo,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Treatment: Drugs: Placebo
Administered SC
Treatment: Drugs: Ixekizumab 80 mg Q4W
Administered SC
Treatment: Drugs: Ixekizumab 80 mg Q2W
Administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
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Assessment method [1]
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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).
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Percentage of Participants Achieving ACR20
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Assessment method [2]
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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.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)
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Assessment method [3]
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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.
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)
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Assessment method [4]
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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.
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75
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Assessment method [5]
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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.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Percentage of Patients Achieving Minimal Disease Activity (MDA)
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Assessment method [6]
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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.
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Timepoint [6]
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Week 24
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Secondary outcome [7]
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Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)
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Assessment method [7]
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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.
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Change From Baseline in Itch Numeric Rating Scale (NRS)
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Week 12
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Secondary outcome [9]
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Change From Baseline in Tender Joint Count (TJC)
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 24
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Secondary outcome [10]
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Change From Baseline in Swollen Joint Count (SJC)
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, Week 24
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Secondary outcome [11]
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Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, Week 24
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Secondary outcome [12]
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Change From Baseline in Patients Global Assessment of Disease Activity VAS
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, Week 24
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Secondary outcome [13]
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Change From Baseline in Physicians Global Assessment of Disease Activity VAS
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, Week 24
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Secondary outcome [14]
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Change From Baseline in C-Reactive Protein (CRP)
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline, Week 24
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Secondary outcome [15]
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Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, Week 24
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Secondary outcome [16]
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Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline, Week 24
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Secondary outcome [17]
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Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, Week 24
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Secondary outcome [18]
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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline, Week 24
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Secondary outcome [19]
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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline, Week 24
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Secondary outcome [20]
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Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
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Assessment method [20]
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Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.
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Timepoint [20]
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Week 24
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Secondary outcome [21]
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Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab
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Assessment method [21]
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The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.
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Timepoint [21]
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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)
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Secondary outcome [22]
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Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab
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Assessment method [22]
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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).
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Timepoint [22]
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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)
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Secondary outcome [23]
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Percentage of Participants Achieving ACR 20
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Assessment method [23]
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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.
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Timepoint [23]
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Week 52 and Week 156
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Secondary outcome [24]
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Percentage of Participants Achieving ACR 50
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Assessment method [24]
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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.
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Timepoint [24]
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Week 52 and Week 156
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Secondary outcome [25]
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Percentage of Participants Achieving ACR 70
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Assessment method [25]
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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.
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Timepoint [25]
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Week 52 and Week 156
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/06/2019
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Sample size
Target
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Accrual to date
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Final
363
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Coast Joint Care - Maroochydore
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Recruitment hospital [3]
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0
Emeritus Research - Camberwell
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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0
4558 - Maroochydore
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Recruitment postcode(s) [3]
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3124 - Camberwell
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Indiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Iowa
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kansas
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Kentucky
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Praha
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Zlin
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France
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France
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Nantes Cedex 1
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France
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Paris CEDEX 14
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France
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Toulouse
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France
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Vandoeuvre Les Nancy
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Germany
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Warszawa
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Madrid
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Spain
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La Coruña
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Malaga
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Sevilla
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Taichung
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West Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
The main purpose of this study is to evaluate how effective and safe the study drug known as
ixekizumab is in participants with active psoriatic arthritis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02349295
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Public notes
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02349295
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