Clinical trial NCT02070978: Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
Official title: A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus Erythematosus, Systemic
Atacicept 75 and 150 mg
LTE
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the discontinuation criteria were invited to enter this long-term extension (LTE) study NCT02070978.


Eligibility criteria: Inclusion Criteria:

* Participants who had completed the 24-week treatment period of study EMR-700461-023 (ADDRESS II core trial)
* Women of childbearing potential who had a negative pregnancy test
* Other protocol defined inclusion criteria were applied

Exclusion Criteria:

* Active neurological symptoms of SLE that were deemed severe or progressive
* Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis
* Pregnancy
* Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the participants unsuitable to continued participation in the study
* Other protocol defined exclusion criteria were applied

Primary outcomes:
measure: Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period
timeFrame: Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks
measure: Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE)
timeFrame: Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks
Secondary outcomes:
measure: Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores
timeFrame: Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score
timeFrame: Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score
timeFrame: Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score
timeFrame: Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score
timeFrame: Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96
measure: Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index)
timeFrame: Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index)
timeFrame: Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose
timeFrame: Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score
timeFrame: Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score
timeFrame: Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72, and Week 96
measure: Number of Participants With Patient Global Impression of Change (PGIC)
timeFrame: Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score
timeFrame: Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores
timeFrame: Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
timeFrame: Baseline: Day 1 (Core study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96
measure: Number of Participants With at Least One Adverse Event
timeFrame: Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks
measure: Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: LTE Day 1, Week 24, Week 48, Week 72 and Week 98
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - (UAB)
state: Alabama
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Fontana
country: United States
facility: Southern California Permenent Medical Group
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc.
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida - Corporate
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: McIlwain Medical Group, PA
state: Florida
city: Grand Blanc
country: United States
facility: AA MRC LLC Ahmed Arif Medical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Medical Associates, P.C.
state: Missouri
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: OMRF
state: Oklahoma
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Austin Regional Clinic, P.A.
state: Texas
city: Waco
country: United States
facility: Little River Arthritis & Osteoporosis Clinic
state: Texas
city: Rosario
country: Argentina
facility: Instituto CAICI
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clinicas Tucuman
state: Tucuman
city: San Miguel de Tucumán
country: Argentina
facility: Centro Integral de Reumatologia
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion (OMI)
city: Ciudad Autonoma Buenos aires
country: Argentina
facility: APRILLUS
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Atencion Integral en Reumatologia (AIR)
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Salta
country: Argentina
facility: Cordis S.A.
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisas em Diabetes Ltda.
state: Rio Grande Do Sul
city: Plovdiv
country: Bulgaria
facility: MHAT "Eurohospital" - Plovdiv, OOD
city: Ruse
country: Bulgaria
facility: Medical Center "Teodora", EOOD
city: Ruse
country: Bulgaria
facility: MHAT - Ruse, AD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: DCC "Sveta Anna", EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Targovishte
country: Bulgaria
facility: MHAT-Targovishte, AD
city: Osorno
country: Chile
facility: Corporacion de Beneficencia Osorno
city: Puerto Varas
country: Chile
facility: Quantum Research Santiago
city: Santiago
country: Chile
facility: Centro Medico Prosalud
city: Santiago
country: Chile
facility: Biomedica
city: Santiago
country: Chile
facility: Centro de Estudios Reumatologicos
city: Viña del Mar
country: Chile
facility: CINVEC - Centro de Investigacion Clinica V Region
city: Praha 2
country: Czechia
facility: Revmatologicky Ustav
city: Uherske Hradiste
country: Czechia
facility: Revmatologicka ambulance
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
state: Rheinland Pfalz
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Saltillo
country: Mexico
facility: Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"
state: Coahuila
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C.
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Icle S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
state: Jalisco
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.
state: Michoacán
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
state: Nuevo León
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el desarrollo Especializado de la Investigacion Clinica en Yucatan
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua, S.C.
city: Arequipa
country: Peru
facility: Hogar Clínica San Juan de Dios - Arequipa
city: Lima
country: Peru
facility: Clinica Medica Cayetano Heredia
city: Lima
country: Peru
facility: Invest Clinicas Sac Inst de Ginecologia y Reproduccion
city: Angeles City, Pampanga
country: Philippines
facility: Angeles University Foundation Medical Center
city: Batangas
country: Philippines
facility: Mary Mediatrix Medical Center
city: Davao
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo
country: Philippines
facility: Iloilo Doctors Hospital
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Moscow
country: Russian Federation
facility: FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
city: Petrozavodsk
country: Russian Federation
facility: SBIH of Republic Kareliya "Republican Hospital n.a. V.A. Baranov"
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "Clinical Rheumatological Hospital # 25"
city: Saratov
country: Russian Federation
facility: SIH "Saratov City Clinical Hospital # 12"
city: Vladimir
country: Russian Federation
facility: SBIH of Vladimir region "Regional Clinical Hospital"
city: Yaroslavl
country: Russian Federation
facility: SBHI of Yaroslavl Region "Clinical Hospital # 8"
city: Durban
country: South Africa
facility: Naidoo, A
state: KwaZulu-Natal
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre
state: Western Cape
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Romford
country: United Kingdom
facility: Queen's Hospital
state: Essex
city: London
country: United Kingdom
facility: University College London Hospitals
state: Greater London
city: London
country: United Kingdom
facility: Guy's Hospital
state: Greater London
Study officials:
affiliation: EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Wallace DJ, Isenberg DA, Morand EF, Vazquez-Mateo C, Kao AH, Aydemir A, Pudota K, Ona V, Aranow C, Merrill JT. Safety and clinical activity of atacicept in the long-term extension of the phase 2b ADDRESS II study in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Nov 3;60(11):5379-5389. doi: 10.1093/rheumatology/keab115.