A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
SPIRIT-P2
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
3 other identifiers
interventional
363
10 countries
109
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2014
Longer than P75 for phase_3
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2014
CompletedStudy Start
First participant enrolled
December 31, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2016
CompletedResults Posted
Study results publicly available
December 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2019
CompletedJuly 1, 2020
September 1, 2019
1.7 years
October 10, 2014
September 6, 2017
June 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
Week 24
Secondary Outcomes (25)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Baseline, Week 24
Percentage of Participants Achieving ACR20
Week 12
Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)
Week 24
Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)
Week 24
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75
Week 12
- +20 more secondary outcomes
Study Arms (3)
Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)
EXPERIMENTALBlinded 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).
Ixekizumab 80 mg Q4W
EXPERIMENTALBlinded 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
PLACEBO COMPARATORBlinded 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).
Interventions
Administered SC
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Rheumatology Associates PC
Birmingham, Alabama, 35205, United States
Arizona Arthritis & Rheumatology Research
Glendale, Arizona, 85304, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, 85210, United States
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, 72205, United States
University of California - San Diego
La Jolla, California, 92093, United States
Purushotham & Akther Kotha MD Inc
La Mesa, California, 91942, United States
Stanford University Hospital
Palo Alto, California, 94304, United States
East Bay Rheumatology Medical Group
San Leandro, California, 94578, United States
Office: Dr Robin K Dore
Tustin, California, 92780, United States
Rheumatology Associates of South Florida
Boca Raton, Florida, 33486, United States
Jeffrey Alper MD Research
Naples, Florida, 34102, United States
Arthritis & Osteoporosis Treatment Center, PA
Orange Park, Florida, 32073, United States
Florida Medical Clinic PA
Zephyrhills, Florida, 33542-7505, United States
Diagnostic Rheumatology and Research
Indianapolis, Indiana, 46227, United States
Physicians Clinic of Iowa
Cedar Rapids, Iowa, 52403, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Bluegrass Community Research. Inc
Lexington, Kentucky, 40504, United States
Johns Hopkins Arthritis Center
Baltimore, Maryland, 21224, United States
Klein and Associates MD, PA
Cumberland, Maryland, 21502, United States
Klein and Associates MD, PA
Hagerstown, Maryland, 21740, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beals Institute PC
Lansing, Michigan, 48917, United States
North MS Medical Clinics, Inc.
Tupelo, Mississippi, 38801, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Glacier View Research Institute
Kalispell, Montana, 59901, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
New Jersey Physicians
Clifton, New Jersey, 07012, United States
Atlantic Coastal Research
Toms River, New Jersey, 08755, United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, 08043, United States
Albuquerque Rehabilitation & Rheumatology, PC
Albuquerque, New Mexico, 87102, United States
The Center for Rheumatology
Albany, New York, 12203, United States
Weill Cornell Medical College
Brooklyn, New York, 11201, United States
Allergy Asthma Immunology of Rochester, AAIR Research Ctr
Rochester, New York, 14618, United States
Rheumatology Associates of Long Island
Smithtown, New York, 11787, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28602, United States
STAT Research
Dayton, Ohio, 45417, United States
Health Research Institute
Oklahoma City, Oklahoma, 73103, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
PMA Medical Specialists, LLC
Limerick, Pennsylvania, 19468, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, 19610, United States
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Wyomissing, Pennsylvania, 19610, United States
Methodist Healthcare
Memphis, Tennessee, 38104-3499, United States
Ramesh C. Gupta MD
Memphis, Tennessee, 38119, United States
Austin Rheumatology Research PA
Austin, Texas, 78705, United States
Austin Regional Clinic
Austin, Texas, 78731, United States
Arthritis Care & Diagnostic Center P.A.
Dallas, Texas, 75231, United States
Pioneer Research Solutions
Houston, Texas, 77008, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Accurate Clinical Research
Houston, Texas, 77084, United States
Accurate Clinical Research
League City, Texas, 77573, United States
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, 79424, United States
Kadlec Clinic Rheumatology
Kennewick, Washington, 99336, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Arthritis Northwest PLLC
Spokane, Washington, 99204, United States
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, 53132, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Coast Joint Care
Maroochydore, Queensland, 4558, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
CCBR Czech Prague, s.r.o.
Prague, 13000, Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, 686 01, Czechia
PV-MEDICAL s.r.o. Revmatologicka ambulance
Zlín, 760 01, Czechia
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, 37170, France
CHU de Montpellier-Hopital Arnaud de Villeneuve
Montpellier, 34295, France
Chru De Nantes Hotel-Dieu
Nantes, 44093, France
Hopital Cochin
Paris, 75679, France
Hopital Purpan
Toulouse, 31059, France
CHU Brabois
Vandœuvre-lès-Nancy, 54511, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, 44649, Germany
Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum
Dresden, Saxony, 01067, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Universität Leipzig - Universitätsklinikum
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, 20095, Germany
Istituto Ortopedico Gaetano Pini
Milan, 20122, Italy
Azienda Ospedaliera - Universitaria Pisana
Pisa, 56126, Italy
Malopolskie Centrum Medyczne S.C.
Krakow, 30-510, Poland
Medica pro Familia Sp z o.o. S.K.A
Krakow, 30002, Poland
AI Centrum Medyczne
Poznan, 61-113, Poland
Medica pro Familia Sp z o.o. S.K.A
Warsaw, 01-868, Poland
Rheuma Medicus Zakład Opieki Zdrowotnej
Warsaw, 02-118, Poland
Hospital Infanta Luisa
Seville, Andalusia, 41007, Spain
Centro de Salud Mental Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, 39008, Spain
Hospital De Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital De Basurto
Bilbao, Vizcaya, 48013, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, 15006, Spain
Hospital Regional Universitario de Málaga
Málaga, 29009, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, 46014, Spain
Chi-Mei Hospital, Liouying
Tainan, Yongkang Dist, Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City (r.o.c), 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, 33305, Taiwan
Basildon and Thurrock University Hospital
Basildon, Essex, SS16 5NL, United Kingdom
King George Hospital
Goodmayes, Essex, IG7 4DY, United Kingdom
Princess Alexandra Hospital
Harlow, Essex, CM20 1QX, United Kingdom
Whipps Cross University Hospital
London, Surrey, E11 1NR, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Chapel Allerton Hospital
Leeds, West Yorkshire, LS7 4SA, United Kingdom
Related Publications (15)
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.
PMID: 40014255DERIVEDTillett 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.
PMID: 38955921DERIVEDArmstrong 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.
PMID: 38814433DERIVEDKirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
PMID: 37400681DERIVEDEder 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.
PMID: 35397092DERIVEDDeodhar 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.
PMID: 35393269DERIVEDCombe 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.
PMID: 33499913DERIVEDOrbai 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.
PMID: 33278016DERIVEDSchweikert 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.
PMID: 32792421DERIVEDCombe 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.
PMID: 31964419DERIVEDTillett 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.
PMID: 31154634DERIVEDCoates 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.
PMID: 30886974DERIVEDGladman 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.
PMID: 30696483DERIVEDGenovese 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.
PMID: 30053162DERIVEDNash 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.
PMID: 28551073DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2014
First Posted
January 28, 2015
Study Start
December 31, 2014
Primary Completion
September 9, 2016
Study Completion
June 26, 2019
Last Updated
July 1, 2020
Results First Posted
December 14, 2017
Record last verified: 2019-09-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.