A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

NCT ID: NCT01695239

Last Updated: 2019-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-09-30

Brief Summary

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This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

Detailed Description

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Conditions

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Psoriasis, Arthritic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ixekizumab Q2W

Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered SC

Ixekizumab Q4W

Administered by 80 mg SC injection every 4 weeks (Q4W).

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered SC

Placebo

Placebo for ixekizumab and placebo for adalimumab administered by SC injection.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Adalimumab Q2W

Administered by 40 mg SC injection Q2W.

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type DRUG

Administered SC

Interventions

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Ixekizumab

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Adalimumab

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY2439821

Eligibility Criteria

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Inclusion Criteria

* Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
* Presence of active psoriatic skin lesion or a personal 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

Exclusion Criteria

* Current or prior use of biologic agents for treatment of Ps or PsA
* Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
* Current use of more than one conventional DMARD
* Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Tuscaloosa, Alabama, United States

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Little Rock, Arkansas, United States

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Upland, California, United States

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Trumbull, Connecticut, United States

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Boca Raton, Florida, United States

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Orange Park, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Marietta, Georgia, United States

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Indianapolis, Indiana, United States

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Cedar Rapids, Iowa, United States

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Wichita, Kansas, United States

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Cumberland, Maryland, United States

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Hagerstown, Maryland, United States

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St Louis, Missouri, United States

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Toms River, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Brooklyn, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Dayton, Ohio, United States

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Duncansville, Pennsylvania, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Jackson, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Kennewick, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Clarksburg, West Virginia, United States

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Genk, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sliven, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Québec, , Canada

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Brno, , Czechia

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Bruntál, , Czechia

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Hlučín, , Czechia

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Ostrava - Trebovice, , Czechia

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Prague, , Czechia

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Zlín, , Czechia

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Tallinn, , Estonia

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Bordeaux, , France

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Nantes, , France

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Orléans, , France

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Toulouse, , France

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Fukuoka, , Japan

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Hokkaido, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Tokyo, , Japan

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Chihuahua City, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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San Luis Potosí City, , Mexico

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Almelo, , Netherlands

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Amsterdam, , Netherlands

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Maastricht, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Sneek, , Netherlands

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Bialystok, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Środa Wielkopolska, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Barnaul, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Petrozavodsk, , Russia

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Saint Petersburg, , Russia

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Yekaterinburg, , Russia

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Barcelona, , Spain

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Bilbao, , Spain

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Córdoba, , Spain

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Majadahonda, , Spain

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Málaga, , Spain

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Sabadell, , Spain

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Santander, , Spain

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Seville, , Spain

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Lutsk, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhia, , Ukraine

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Cambridge, Cambridgeshire, United Kingdom

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Goodmayes, Essex, United Kingdom

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London, Greater London, United Kingdom

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Headington, Oxford, United Kingdom

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Wolverhampton, West Midlands, United Kingdom

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Bradford, West Yorkshire, United Kingdom

Site Status

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Leeds, West Yorkshire, United Kingdom

Site Status

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Liverpool, , United Kingdom

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Countries

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United States Belgium Bulgaria Canada Czechia Estonia France Japan Mexico Netherlands Poland Russia Spain Ukraine United Kingdom

References

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Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials. Rheumatol Ther. 2025 Apr;12(2):381-395. doi: 10.1007/s40744-025-00748-8. Epub 2025 Feb 27.

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Tillett W, Birt J, Vadhariya A, Ross S, Ngantcha M, Ng KJ. Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint. Rheumatol Ther. 2024 Oct;11(5):1101-1114. doi: 10.1007/s40744-024-00690-1. Epub 2024 Jul 2.

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Armstrong AW, Jaleel T, Merola JF, Gottlieb AB, Khattri S, Helt CC, Malatestinic WN, Ross SE, Ngantcha ME, de Vlam K. Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity. Dermatol Ther (Heidelb). 2024 Jun;14(6):1615-1631. doi: 10.1007/s13555-024-01188-y. Epub 2024 May 30.

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PMID: 38814433 (View on PubMed)

Kameda H, Hagimori K, Morisaki Y, Holzkamper T, Konomi A, Dobashi H. Ixekizumab Efficacy in Patients with Severe Peripheral Psoriatic Arthritis: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (SPIRIT-P1). Rheumatol Ther. 2023 Dec;10(6):1683-1703. doi: 10.1007/s40744-023-00605-6. Epub 2023 Oct 19.

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PMID: 37858007 (View on PubMed)

Coates LC, Smolen JS, Mease PJ, Husni ME, Merola JF, Lespessailles E, Kishimoto M, Macpherson L, Bradley AJ, Bolce R, Helliwell PS. Comparative performance of composite measures from two phase III clinical trials of ixekizumab in psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002457. doi: 10.1136/rmdopen-2022-002457.

Reference Type DERIVED
PMID: 36171019 (View on PubMed)

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.

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PMID: 35397092 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35393269 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33499913 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32792421 (View on PubMed)

Chandran V, van der Heijde D, Fleischmann RM, Lespessailles E, Helliwell PS, Kameda H, Burgos-Vargas R, Erickson JS, Rathmann SS, Sprabery AT, Birt JA, Shuler CL, Gallo G. Ixekizumab treatment of biologic-naive patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020 Oct 1;59(10):2774-2784. doi: 10.1093/rheumatology/kez684.

Reference Type DERIVED
PMID: 32031665 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31964419 (View on PubMed)

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.

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PMID: 31154634 (View on PubMed)

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.

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PMID: 30886974 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30696483 (View on PubMed)

Gottlieb AB, Strand V, Kishimoto M, Mease P, Thaci D, Birt J, Lee CH, Shuler CL, Lin CY, Gladman DD. Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naive patients with active psoriatic arthritis (SPIRIT-P1). Rheumatology (Oxford). 2018 Oct 1;57(10):1777-1788. doi: 10.1093/rheumatology/key161.

Reference Type DERIVED
PMID: 29945203 (View on PubMed)

Coates LC, Kishimoto M, Gottlieb A, Shuler CL, Lin CY, Lee CH, Mease PJ. Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naive patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. RMD Open. 2017 Dec 22;3(2):e000567. doi: 10.1136/rmdopen-2017-000567. eCollection 2017.

Reference Type DERIVED
PMID: 29299340 (View on PubMed)

van der Heijde D, Gladman DD, Kishimoto M, Okada M, Rathmann SS, Moriarty SR, Shuler CL, Carlier H, Benichou O, Mease PJ. Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1). J Rheumatol. 2018 Mar;45(3):367-377. doi: 10.3899/jrheum.170429. Epub 2017 Dec 15.

Reference Type DERIVED
PMID: 29247148 (View on PubMed)

Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, Lin CY, Braun DK, Lee CH, Gladman DD; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017 Jan;76(1):79-87. doi: 10.1136/annrheumdis-2016-209709. Epub 2016 Aug 23.

Reference Type DERIVED
PMID: 27553214 (View on PubMed)

Other Identifiers

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I1F-MC-RHAP

Identifier Type: OTHER

Identifier Source: secondary_id

13731

Identifier Type: -

Identifier Source: org_study_id

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