A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT-P2)

• ClinicalTrials.gov Identifier: NCT02349295
• Recruitment Status: Completed
• First Posted: January 28, 2015
• Results First Posted: December 14, 2017
• Last Update Posted: July 1, 2020
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Drug: Placebo; Drug: Ixekizumab 80 mg Q4W; Drug: Ixekizumab 80 mg Q2W	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 363 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: December 31, 2014
• Actual Primary Completion Date: September 9, 2016
• Actual Study Completion Date: June 26, 2019

Arms and Interventions

Arm	Intervention/treatment
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).	Drug: Placebo; Administered SC; Drug: Ixekizumab 80 mg Q2W; Administered SC; Other Name: LY2439821
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).	Drug: Placebo; Administered SC; Drug: Ixekizumab 80 mg Q4W; Administered SC; Other Name: LY2439821
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).	Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20) [ Time Frame: Week 24 ]
   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).

Secondary Outcome Measures :

1. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Week 24 ]
   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.
2. Percentage of Participants Achieving ACR20 [ Time Frame: Week 12 ]
   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.
3. Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50) [ Time Frame: Week 24 ]
   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.
4. Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70) [ Time Frame: Week 24 ]
   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.
5. Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 [ Time Frame: Week 12 ]
   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.
6. Percentage of Patients Achieving Minimal Disease Activity (MDA) [ Time Frame: Week 24 ]
   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.
7. Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI) [ Time Frame: Week 24 ]
   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.
8. Change From Baseline in Itch Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 12 ]
   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.
9. Change From Baseline in Tender Joint Count (TJC) [ Time Frame: Baseline, Week 24 ]
   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.
10. Change From Baseline in Swollen Joint Count (SJC) [ Time Frame: Baseline, Week 24 ]
    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.
11. Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 24 ]
    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.
12. Change From Baseline in Patients Global Assessment of Disease Activity VAS [ Time Frame: Baseline, Week 24 ]
    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.
13. Change From Baseline in Physicians Global Assessment of Disease Activity VAS [ Time Frame: Baseline, Week 24 ]
    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.
14. Change From Baseline in C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 24 ]
    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.
15. Change From Baseline in Disease Activity Score-CRP (DAS28-CRP) [ Time Frame: Baseline, Week 24 ]
    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.
16. Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score [ Time Frame: Baseline, Week 24 ]
    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.
17. Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 24 ]
    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.
18. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS) [ Time Frame: Baseline, Week 24 ]
    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.
19. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS) [ Time Frame: Baseline, Week 24 ]
    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.
20. Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) [ Time Frame: Week 24 ]
    Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.
21. Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab [ Time Frame: 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) ]
    The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.
22. Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab [ Time Frame: 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) ]
    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).
23. Percentage of Participants Achieving ACR 20 [ Time Frame: Week 52 and Week 156 ]
    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.
24. Percentage of Participants Achieving ACR 50 [ Time Frame: Week 52 and Week 156 ]
    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.
25. Percentage of Participants Achieving ACR 70 [ Time Frame: Week 52 and Week 156 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Rheumatology Associates PC

Birmingham, Alabama, United States, 35205

United States, Arizona

Arizona Arthritis & Rheumatology Research

Glendale, Arizona, United States, 85304

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, United States, 85210

Arizona Arthritis & Rheumatology Research

Phoenix, Arizona, United States, 85032

United States, Arkansas

Little Rock Diagnostic Clinic

Little Rock, Arkansas, United States, 72205

United States, California

University of California - San Diego

La Jolla, California, United States, 92093

Purushotham & Akther Kotha MD Inc

La Mesa, California, United States, 91942

Stanford University Hospital

Palo Alto, California, United States, 94304

East Bay Rheumatology Medical Group

San Leandro, California, United States, 94578

Office: Dr Robin K Dore

Tustin, California, United States, 92780

United States, Florida

Rheumatology Associates of South Florida

Boca Raton, Florida, United States, 33486

Jeffrey Alper MD Research

Naples, Florida, United States, 34102

Arthritis & Osteoporosis Treatment Center, PA

Orange Park, Florida, United States, 32073

Florida Medical Clinic PA

Zephyrhills, Florida, United States, 33542-7505

United States, Indiana

Diagnostic Rheumatology and Research

Indianapolis, Indiana, United States, 46227

United States, Iowa

Physicians Clinic of Iowa

Cedar Rapids, Iowa, United States, 52403

United States, Kansas

Heartland Research Associates

Wichita, Kansas, United States, 67207

United States, Kentucky

Bluegrass Community Research. Inc

Lexington, Kentucky, United States, 40504

United States, Maryland

Johns Hopkins Arthritis Center

Baltimore, Maryland, United States, 21224

Klein and Associates MD, PA

Cumberland, Maryland, United States, 21502

Klein and Associates MD, PA

Hagerstown, Maryland, United States, 21740

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

United States, Michigan

Beals Institute PC

Lansing, Michigan, United States, 48917

United States, Mississippi

North MS Medical Clinics, Inc.

Tupelo, Mississippi, United States, 38801

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, Montana

Glacier View Research Institute

Kalispell, Montana, United States, 59901

United States, Nebraska

Physician Research Collaboration, LLC

Lincoln, Nebraska, United States, 68516

United States, New Jersey

New Jersey Physicians

Clifton, New Jersey, United States, 07012

Atlantic Coastal Research

Toms River, New Jersey, United States, 08755

Arthritis, Rheumatic & Back Disease Associates

Voorhees, New Jersey, United States, 08043

United States, New Mexico

Albuquerque Rehabilitation & Rheumatology, PC

Albuquerque, New Mexico, United States, 87102

United States, New York

The Center for Rheumatology

Albany, New York, United States, 12203

Weill Cornell Medical College

Brooklyn, New York, United States, 11201

Allergy Asthma Immunology of Rochester, AAIR Research Ctr

Rochester, New York, United States, 14618

Rheumatology Associates of Long Island

Smithtown, New York, United States, 11787

United States, North Carolina

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, United States, 28207

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States, 28210

PMG Research of Hickory, LLC

Hickory, North Carolina, United States, 28602

United States, Ohio

STAT Research

Dayton, Ohio, United States, 45417

United States, Oklahoma

Health Research Institute

Oklahoma City, Oklahoma, United States, 73103

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

PMA Medical Specialists, LLC

Limerick, Pennsylvania, United States, 19468

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, United States, 19610

Pennsylvania Regional Center for Arthritis & Osteoarthritis

Wyomissing, Pennsylvania, United States, 19610

United States, Tennessee

Methodist Healthcare

Memphis, Tennessee, United States, 38104-3499

Ramesh C. Gupta MD

Memphis, Tennessee, United States, 38119

United States, Texas

Austin Rheumatology Research PA

Austin, Texas, United States, 78705

Austin Regional Clinic

Austin, Texas, United States, 78731

Arthritis Care & Diagnostic Center P.A.

Dallas, Texas, United States, 75231

Pioneer Research Solutions

Houston, Texas, United States, 77008

Houston Institute for Clinical Research

Houston, Texas, United States, 77074

Accurate Clinical Research

Houston, Texas, United States, 77084

Accurate Clinical Research

League City, Texas, United States, 77573

Arthritis & Osteoporosis Associates LLP

Lubbock, Texas, United States, 79424

United States, Washington

Kadlec Clinic Rheumatology

Kennewick, Washington, United States, 99336

Swedish Medical Center

Seattle, Washington, United States, 98122

Arthritis Northwest PLLC

Spokane, Washington, United States, 99204

United States, Wisconsin

Rheumatology and Immunotherapy Center

Franklin, Wisconsin, United States, 53132

Australia, New South Wales

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Australia, Queensland

Coast Joint Care

Maroochydore, Queensland, Australia, 4558

Australia, Victoria

Emeritus Research

Camberwell, Victoria, Australia, 3124

Czechia

CCBR Czech Prague, s.r.o.

Praha, Czechia, 13000

MEDICAL PLUS, s.r.o.

Uherske Hradiste, Czechia, 686 01

PV-MEDICAL s.r.o. Revmatologicka ambulance

Zlin, Czechia, 760 01

France

Hôpital Trousseau, CHRU de Tours

Chambray-lès-Tours, France, 37170

CHU de Montpellier-Hopital Arnaud de Villeneuve

Montpellier Cedex 5, France, 34295

Chru De Nantes Hotel-Dieu

Nantes Cedex 1, France, 44093

Hopital Cochin

Paris CEDEX 14, France, 75679

Hopital Purpan

Toulouse, France, 31059

CHU Brabois

Vandoeuvre Les Nancy, France, 54511

Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Württemberg, Germany, 69120

Universitätsklinikum Würzburg

Würzburg, Bayern, Germany, 97080

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hessen, Germany, 60590

Rheumazentrum Ruhrgebiet

Herne, Nordrhein-Westfalen, Germany, 44649

Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum

Dresden, Sachsen, Germany, 01067

Universitätsklinikum Carl Gustav Carus

Dresden, Sachsen, Germany, 01307

Universität Leipzig - Universitätsklinikum

Leipzig, Sachsen, Germany, 04103

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany, 23538

Charité Universitätsmedizin Berlin

Berlin, Germany, 10117

HRF Hamburger Rheuma Forschungszentrum

Hamburg, Germany, 20095

Italy

Istituto Ortopedico Gaetano Pini

Milano, Italy, 20122

Azienda Ospedaliera - Universitaria Pisana

Pisa, Italy, 56126

Poland

Malopolskie Centrum Medyczne S.C.

Krakow, Poland, 30-510

Medica pro Familia Sp z o.o. S.K.A

Krakow, Poland, 30002

AI Centrum Medyczne

Poznan, Poland, 61-113

Medica pro Familia Sp z o.o. S.K.A

Warszawa, Poland, 01-868

Rheuma Medicus Zakład Opieki Zdrowotnej

Warszawa, Poland, 02-118

Spain

Hospital Infanta Luisa

Sevilla, Andalucia, Spain, 41007

Centro de Salud Mental Parc Tauli

Sabadell, Barcelona, Spain, 08208

Hospital Universitario Marques De Valdecilla

Santander, Cantabria, Spain, 39008

Hospital De Fuenlabrada

Fuenlabrada, Madrid, Spain, 28942

Hospital De Basurto

Bilbao, Vizcaya, Spain, 48013

Complexo Hospitalario Universitario A Coruña, CHUAC

La Coruña, Spain, 15006

Hospital Regional Universitario de Málaga

Malaga, Spain, 29009

Hospital Universitario Nuestra Señora de Valme

Sevilla, Spain, 46014

Taiwan

Chi-Mei Hospital, Liouying

Tainan City, Yongkang Dist, Taiwan

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City (r.o.c), Taiwan, 83301

Chung Shan Medical University Hospital

Taichung City, Taiwan, 40201

China Medical University Hospital

Taichung, Taiwan, 40447

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Taiwan University Hospital

Taipei, Taiwan, 10002

Chang Gung Memorial Hospital - Linkou

Taoyuan City, Taiwan, 33305

United Kingdom

Basildon and Thurrock University Hospital

Basildon, Essex, United Kingdom, SS16 5NL

King George Hospital

Goodmayes, Essex, United Kingdom, IG7 4DY

Princess Alexandra Hospital

Harlow, Essex, United Kingdom, CM20 1QX

Whipps Cross University Hospital

London, Surrey, United Kingdom, E11 1NR

New Cross Hospital

Wolverhampton, West Midlands, United Kingdom, WV10 0QP

Chapel Allerton Hospital

Leeds, West Yorkshire, United Kingdom, LS7 4SA

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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); Eli Lilly and Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.

Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

Orbai AM, Gratacos J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.

Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.

Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02349295
• Other Study ID Numbers: 14310; I1F-MC-RHBE ( Other Identifier: Eli Lilly and Company ); 2011-002328-42 ( EudraCT Number )
• First Posted: January 28, 2015
• Results First Posted: December 14, 2017
• Last Update Posted: July 1, 2020
• Last Verified: September 1, 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: https://vivli.org/

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ixekizumab; Dermatologic Agents