A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
NCT ID: NCT01695239
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
417 participants
INTERVENTIONAL
2012-12-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ixekizumab Q2W
Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).
Ixekizumab
Administered SC
Ixekizumab Q4W
Administered by 80 mg SC injection every 4 weeks (Q4W).
Ixekizumab
Administered SC
Placebo
Placebo for ixekizumab and placebo for adalimumab administered by SC injection.
Placebo
Administered SC
Adalimumab Q2W
Administered by 40 mg SC injection Q2W.
Adalimumab
Administered SC
Interventions
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Ixekizumab
Administered SC
Placebo
Administered SC
Adalimumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leeds, West Yorkshire, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Liverpool, , United Kingdom
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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