Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
NCT ID: NCT00624338
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
461 participants
INTERVENTIONAL
2008-01-31
2012-10-31
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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Atacicept 75 mg
Atacicept 75 mg
75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Atacicept 150 mg
Atacicept 150 mg
150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Placebo
Placebo Comparator
Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Interventions
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Atacicept 75 mg
75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Atacicept 150 mg
150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Placebo Comparator
Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Eligibility Criteria
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Inclusion Criteria
* Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
* Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
* Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
* Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication
Exclusion Criteria
* Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
* Previous treatment with rituximab, abatacept, or belimumab
* History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
16 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Research Site
Rijeka, , Croatia
Division of Clinical Immunology and Rheumatology - UAB
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Research Site
San Diego, California, United States
Inland Rheumatology Clinical Trials Inc
Upland, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Boise, Idaho, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
US Local Medical Information
Rockland, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Justus J. Fiechtner, MD, MPH
Lansing, Michigan, United States
SUNY Health Science Center at Brooklyn
Brooklyn, New York, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
Hospital for Special Surgey
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
University of Cincinnati Medical Center, Division of Immunology
Cincinnati, Ohio, United States
Research Site
Temple, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Research Site
Buenos Aires, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Quilmes, , Argentina
Research Site
San Juan, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Cairns, , Australia
Research Site
Clayton, Victoria, , Australia
Research Site
Sunshine Coast, Queensland, , Australia
Research Site
Woodville S.A., , Australia
Research Site
Wein, , Austria
Research Site
Sofia, , Bulgaria
Research Site
Osijek, , Croatia
Research Site
Split, , Croatia
Research Site
Zagreb, , Croatia
Research Site
Prague, , Czechia
Research Site
Bordeaux Pessac, , France
Research Site
Lille, , France
Research Site
Montpelier Cedex, , France
Research Site
Paris, , France
Research Site
Strasbourg, , France
Research Site
Toulouse, , France
Research Site
Berlin, , Germany
Research Site
Erlangen, , Germany
Research Site
Hanover, , Germany
Research Site
Heidelberg, , Germany
Research Site
Herne, , Germany
Research Site
München, , Germany
Research Site
Münster, , Germany
Research Site
Athens, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Secunderabad, Andhra Pradesh, , India
Research Site
Haifa, , Israel
Research Site
Jerasalem, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Riga, , Latvia
Research Site
Beirut, , Lebanon
Research Site
Kaunas, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Kuala Lumpur, , Malaysia
Research Site
Perak, , Malaysia
Research Site
Seremban, , Malaysia
Research Site
Guadalajara Jalisco, , Mexico
Research Site
Tijuana, BC, , Mexico
Research Site
Amsterdam, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Maastricht, , Netherlands
Research Site
Angeles City, Pampanga, Philippines
Research Site
Davao City, , Philippines
Research Site
Iloilo City, , Philippines
Research Site
Las Piñas, , Philippines
Research Site
Manila, , Philippines
Research Site
Bialystok, , Poland
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Szczecin, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Kemerovo, , Russia
Research Site
Petrozavodsk, , Russia
Research Site
Ryazan, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Tula, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Belgrade, , Serbia
Research Site
New Belgrade, , Serbia
Research Site
Niška Banja, , Serbia
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Panorama, Western Cape, , South Africa
Research Site
Parlow, Western Cape, , South Africa
Research Site
Pinelands, , South Africa
Research Site
Stellenbosch, Western Cape, , South Africa
Research Site
Gyeonggi-do, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Sankt Gallen, , Switzerland
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Donetsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Zhytomyr, , Ukraine
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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References
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Pitsiu M, Yalkinoglu O, Farrell C, Girard P, Vazquez-Mateo C, Papasouliotis O. Population pharmacokinetics of atacicept in systemic lupus erythematosus: An analysis of three clinical trials. CPT Pharmacometrics Syst Pharmacol. 2023 Aug;12(8):1157-1169. doi: 10.1002/psp4.12982. Epub 2023 Jun 18.
Eslami M, Willen D, Papasouliotis O, Schuepbach-Mallpell S, Willen L, Donze O, Yalkinoglu O, Schneider P. Kinetics of free and ligand-bound atacicept in human serum. Front Immunol. 2022 Dec 2;13:1035556. doi: 10.3389/fimmu.2022.1035556. eCollection 2022.
Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015 Nov;74(11):2006-15. doi: 10.1136/annrheumdis-2013-205067. Epub 2014 Jun 20.
Other Identifiers
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27646
Identifier Type: -
Identifier Source: org_study_id
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