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재발완성다발성경화증(RRMS) 소아 환자 대상 BG00012의 3상 효능 및 안전성 연구 (CONNECT)

2026년 5월 16일 업데이트: Biogen

재발 완화성 다발성 경화증이 있는 10세에서 18세 미만의 소아에서 BG00012의 공개 라벨, 무작위, 다기관, 다중 용량, 활성 제어, 병렬 그룹, 효능 및 안전성 연구(선택적 공개 라벨 확장 포함)

파트 1의 주요 목적은 다음과 같습니다. RRMS가 있는 소아 대상에서 질병 수정 치료와 비교하여 BG00012의 안전성, 내약성 및 효능을 평가하고 건강 결과 및 장애의 진화를 평가합니다. 파트 2의 주요 목적은 연구 109MS306의 파트 1에서 96주차를 완료한 피험자에서 BG00012의 장기 안전성을 평가하는 것입니다. 파트 2의 2차 목적은 연구 109MS306의 파트 1에서 96주를 완료한 피험자에서 BG00012의 장기 MS 결과를 설명하는 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

156

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 덴마크
      • Aarhus N, 덴마크, 8200
        • Århus Universitetshospital
      • Copenhagen, 덴마크, 2100
        • Rigshospitalet
      • Odense, 덴마크, 5000
        • Odense Universitetshospital
  • 독일
    • Bavaria
      • Augsburg, Bavaria, 독일, 86156
        • Universitaetsklinikum Augsburg
      • Munich, Bavaria, 독일, 80337
        • Klinikum der Universitaet Muenchen
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, 독일, 44791
        • Katholisches Klinikum Bochum gGmbH
  • 미국
    • Massachusetts
      • Boston, Massachusetts, 미국, 2115
        • Boston Children's Hospital
    • Virginia
      • Charlottesville, Virginia, 미국, 22903
        • The Rector and Visitors of the University of Virginia
  • 벨기에
      • Brussels, 벨기에, 1020
        • Universitair Kinderziekenhuis Koningin Fabiola
      • Ghent, 벨기에, 9000
        • Universitair Ziekenhuis Ghent
  • 불가리아
      • Sofia, 불가리아, 1113
        • MHATNP 'Sv.Naum', EAD
  • 세르비아
      • Belgrade, 세르비아, 11000
        • Clinic of Neurology and Psychiatry for Children and Youth
      • Belgrade, 세르비아, 11000
        • Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''
      • Kragujevac, 세르비아, 34000
        • University Clinical Center Kragujevac
  • 스웨덴
      • Gothenburg, 스웨덴, 41345
        • Sahlgrenska Sjukhuset
      • Stockholm, 스웨덴, SE-113 61
        • Karolinska
  • 스페인
      • Seville, 스페인, 41009
        • Hospital Universitario Virgen Macarena
    • Barcelona
      • Esplugues de Llobregat, Barcelona, 스페인, 8950
        • Hospital Sant Joan de Déu
    • Córdoba
      • Córdoba, Córdoba, 스페인, 14011
        • Hospital Universitario Reina Sofia
    • Madrid
      • Torrejón de Ardoz, Madrid, 스페인, 28850
        • Hospital Universitario De Torrejon
  • 영국
    • Greater London
      • London, Greater London, 영국, WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery
      • London, Greater London, 영국, WC1N 3JH
        • Great Ormond Street Hospital for Children
      • London, Greater London, 영국, SE1 7EH
        • Evelina London Children's Hospital
    • West Midlands
      • Birmingham, West Midlands, 영국, B4 6NH
        • Birmingham Children's Hospital
  • 이스라엘
      • Jerusalem, 이스라엘, 91120
        • Hadassah University Hospital - Ein Kerem
      • Petah Tikva, 이스라엘, 4920235
        • Schneider Children's Medical Center
      • Ramat Gan, 이스라엘, 5265601
        • Chaim Sheba Medical Center
  • 이탈리아
      • Bari, 이탈리아, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Genova, 이탈리아, 16132
        • IRCCS Ospedale Policlinico San Martino
      • Milan, 이탈리아, 20132
        • Ospedale San Raffaele
      • Naples, 이탈리아, 80131
        • Azienda Ospedaliera Universitaria 'Federico II'
      • Padova, 이탈리아, 35128
        • Azienda Ospedale-Università di Padova
      • Palermo, 이탈리아, 90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Roma, 이탈리아, 00189
        • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
      • Roma, 이탈리아, 00165
        • Ospedale Pediatrico Bambino Gesu
    • Varese
      • Gallarate, Varese, 이탈리아, 21013
        • Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
  • 체코
      • Brno, 체코, 656 91
        • Fakultni nemocnice u sv. Anny v Brne
      • Hradec Králové, 체코, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Jihlava, 체코, 58633
        • Nemocnice Jihlava p.o.
      • Ostrava, 체코, 708 52
        • Fakultni Nemocnice Ostrava
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T3B 6A8
        • University of Calgary - Alberta Children's Hospital
  • 쿠웨이트
      • Ash Shuwaykh, 쿠웨이트, 12345
        • Ibn Sina Hospital
  • 터키 (Türkiye)
      • Ankara, 터키 (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Antalya, 터키 (Türkiye), 07070
        • Akdeniz University Faculty of Medicine
  • 폴란드
      • Bialystok, 폴란드, 15-274
        • SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
      • Gdansk, 폴란드, 80-211
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, 폴란드, 93-338
        • Instytut Centrum Zdrowia Matki Polki
      • Poznan, 폴란드, 60-355
        • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
      • Warsaw, 폴란드, 04-730
        • Instytut 'Pomnik - Centrum Zdrowia Dziecka'
  • 프랑스
    • Bas Rhin
      • Strasbourg, Bas Rhin, 프랑스, 67098
        • CHU Strasbourg - Hôpital Hautepierre
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, 프랑스, 13385
        • Hôpital de la Timone
    • Côte-d'Or
      • Dijon, Côte-d'Or, 프랑스, 21079
        • CHU Dijon -BOCAGE CENTRAL
    • Herault
      • Montpellier, Herault, 프랑스, 34295
        • Hôpital Gui de Chauliac
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, 프랑스, 35033
        • CHU Rennes - Hôpital Pontchaillou
    • Meurthe Et Moselle
      • Vandœuvre-lès-Nancy, Meurthe Et Moselle, 프랑스, 54500
        • Hôpital de Brabois Enfants
    • Nord
      • Lille, Nord, 프랑스, 59037
        • Hopital Roger Salengro - CHU Lille
    • Puy De Dome
      • Clermont-Ferrand, Puy De Dome, 프랑스, 63003
        • CHU Clermont Ferrand - Hopital d'Estaing
    • Rhone
      • Bron, Rhone, 프랑스, 69677
        • Hopital Neurologique Pierre Wertheimer
    • Somme
      • Amiens, Somme, 프랑스, 80054
        • CHU Amiens - Hopital Sud
    • Val De Marne
      • Le Kremlin-Bicêtre, Val De Marne, 프랑스, 94275
        • Hôpital Bicêtre
  • 헝가리
      • Budapest, 헝가리, 1083
        • Semmelweis Egyetem
      • Budapest, 헝가리, 1089
        • Heim Pal Orszagos Gyermekgyogyaszati Intezet

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

10년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

설명

주요 포함 기준:

  • 체중이 30kg 이상이어야 합니다.
  • RRMS 진단이 있어야 합니다(소아 RRMS에 대한 합의된 정의 [Krupp 2007]).
  • 기준선 EDSS 점수가 0에서 5.5 사이여야 합니다.
  • 다음 3가지 조건 중 1가지 이상을 경험해야 합니다. b) MS와 일치하는 병변을 나타내는 이전 뇌 MRI와 함께 1일 전 지난 24개월 이내에 적어도 2회의 재발; c) 1일 전 6주 이내에 수행된 MRI에서 뇌의 Gd-향상 병변의 증거.
  • 1일 전 50일 이내에 재발의 증거가 없고 1일 전 30일 이내에 코르티코스테로이드 치료의 증거가 없어야 하며 신경학적으로 안정적이어야 합니다.
  • 성적으로 왕성한 가임 가능성이 있는 피험자는 연구 기간 동안 효과적인 피임법을 실행할 의향이 있어야 하며 연구 치료의 최종 투여 후 최소 30일 동안 피임을 계속할 의향과 능력이 있어야 합니다.

주요 제외 기준:

  • 1차 진행성, 2차 진행성 또는 진행성 재발 MS([Lublin and Reingold 1996]에 의해 정의됨). 이러한 상태는 최소 3개월의 기간 동안 악화되는 지속적인 임상 질환의 존재를 필요로 합니다. 이러한 조건을 가진 피험자는 재발이 중첩될 수도 있지만 임상적으로 안정한 기간이나 임상적 개선이 없다는 점에서 재발-완화 피험자와 구별됩니다.
  • 기타 탈수초성 장애(예: 급성 파종성 뇌척수염), 전신 자가면역 장애(예: 쇼그렌병, 홍반성 루푸스), 대사 장애(예: 이영양증) 및 감염성 장애와 같은 MS를 모방하는 장애.
  • 전암 또는 악성 질환의 병력. 스크리닝 전에 완전히 절제된 기저 세포 암종이 있는 피험자는 자격이 유지됩니다.
  • 심각한 알레르기 또는 아나필락시 반응의 병력 또는 DMF, 푸마르산 에스테르 또는 인터페론 베타-1a(IFN 베타-1a)에 대한 알려진 약물 과민증의 병력.
  • 중요한 내분비, 혈액, 간, 면역, 대사, 비뇨기, 신장 및/또는 임상 연구 참여를 방해하는 기타 주요 질병을 나타내는 비정상적인 실험실 결과의 병력.

  • 임상적으로 중요한 심혈관, 폐, 위장관, 피부, 성장, 발달, 정신과(우울증 포함), 신경계(MS 제외) 및/또는 임상 연구 참여를 방해하는 기타 주요 질병의 병력.

    -.Human Immunodeficiency Virus의 역사.

  • 1일 이전 50일 이내에 발생한 MS 재발 및/또는 대상체가 1일 이전의 이전 재발로부터 안정화되지 않았습니다.
  • 조사자 또는 Biogen Idec의 의견에 따라 피험자를 등록에 부적합하게 만드는 기타 불특정 이유.
  • 대상의 PD/PK 하위 집합의 경우: 대상은 BG00012 캡슐 전체를 삼킬 수 없습니다.

주요 치료 내역

  • Fumaderm(푸마르산 에스테르) 또는 BG00012를 사용한 이전 치료.
  • 다음 중 하나를 사용한 사전 치료: 총 림프구 방사선 조사, 클라드리빈, T 세포 또는 T 세포 수용체 백신 접종, 리툭시맙 또는 나탈리주맙을 제외한 모든 치료용 단클론 항체.
  • 1일 전 12개월 이내에 다음 약물 중 하나를 사용한 이전 치료: 미톡산트론, 시클로포스파미드, 리툭시맙.
  • 1일 전 6개월 이내에 다음 약물 또는 절차 중 하나로 사전 치료: 핀골리모드; 테리플루노마이드; 나탈리주맙; 사이클로스포린; 아자티오프린; 메토트렉세이트; 마이코페놀레이트 모페틸; 라퀴니모드; 정맥내(IV) 면역글로불린; 혈장분리반출술 또는 세포분리반출술
  • 1일 전 30일 이내에 다음 약물 중 하나로 치료: 스테로이드(IV 또는 경구 코르티코스테로이드 치료, 코르티코스테로이드 경로를 통해 작용하지 않을 수 있는 제제[예: 저용량 날트렉손] 포함), 4-아미노피리딘 또는 관련 제품(대상 제외) 3개월 동안 안정적인 용량의 제어 방출 팜프리딘)

참고: 다른 프로토콜 정의 포함/제외 기준이 적용될 수 있습니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: BG00012
참가자는 1일 2회 240mg의 권장 복용량을 구두로 받게 됩니다.
의약품: 푸마르산디메틸
경구 투여
다른 이름들:
  • BG00012
  • 텍피데라
활성 비교기: IFN β-1a(아보넥스)
참가자는 30μg(매주)의 권장 복용량을 받게 됩니다.
의약품: 인터페론 β-1a
근육 주사로 투여
다른 이름들:
  • 아보넥스

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans
기간: At Week 96
Participants who were free of new or newly enlarging T2 hyperintense lesions were assessed on Brain MRI scans.
At Week 96
Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
기간: From Week 96 up to last follow-up visit (up to Week 340)
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of the Investigator, placed the participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. TEAEs were defined as AEs occurring or worsening after beginning study treatment (after the first dose).
From Week 96 up to last follow-up visit (up to Week 340)
Part 2: Number of Participants Who Discontinued Study Treatment Due to an AE
기간: From Week 96 up to last follow-up visit (up to Week 340)
An AE was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Week 96 up to last follow-up visit (up to Week 340)

2차 결과 측정

결과 측정
측정값 설명
기간
Part 1: Number of New or Newly Enlarged T2 Hyperintense Lesions on Brain MRI Scans
기간: At Weeks 24 and Week 96
The number of new or newly enlarging T2 hyperintense lesions that developed in each participant was assessed on Brain MRI scans.
At Weeks 24 and Week 96
Part 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans
기간: At Weeks 24 and 48
Participants who were free of new or newly enlarging T2 hyperintense lesions were assessed on Brain MRI scans.
At Weeks 24 and 48
Part 1: Proportion of Participants Free of New MRI Activity as Measured by Brain MRI Scans
기간: At Weeks 24, 48, and 96
Participants free of Gd-enhancing MRI lesions and new or newly enlarging T2 MRI lesions were assessed on Brain MRI Scans.
At Weeks 24, 48, and 96
Part 1: Time to First Relapse
기간: Up to Week 96
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The time to first relapse was defined as the time from the first dose in Part 1 up to the first relapse. Time to First Relapse was estimated by Kaplan-Meier method.
Up to Week 96
Part 1: Proportion of Relapse-Free Participants
기간: Up to Week 96
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The proportion of relapse-free participants was estimated using the Kaplan-Meier method.
Up to Week 96
Part 1: Annualized Relapse Rate (ARR)
기간: At Weeks 48 and 96
ARR is calculated as the total number of relapses that occurred during the study divided by the total number of participant-years. ARR was analyzed using negative binomial regression model.
At Weeks 48 and 96
Part 1: Number of Participants With TEAEs and TESAEs
기간: From Day 1 up to Week 96
An AE was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of the Investigator, placed the participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. TEAEs were defined as AEs occurring or worsening after beginning study treatment (after the first dose).
From Day 1 up to Week 96
Part 1: Change From Baseline in Vital Signs (Temperature)
기간: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in temperature.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Change From Baseline in Vital Signs (Pulse Rate)
기간: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in pulse rate.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Change From Baseline in Vital Signs (Blood Pressure)
기간: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in blood pressure.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Change From Baseline in Vital Signs (Respiratory Rate)
기간: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in respiratory rate.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Number of Participants With Shifts From Baseline in Electrocardiograms (ECG) Abnormalities
기간: Up to Week 96
Clinical significance of abnormalities in ECG was determined based on the investigator's discretion. Shift to abnormal indicated values that were normal or unknown at baseline and shifted to abnormal values post-baseline.
Up to Week 96
Part 1: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)
기간: Baseline up to Week 96
Hematology parameters included leukocytes, erythrocytes, hemoglobin, hematocrit, platelets, eosinophils, lymphocytes, monocytes and neutrophils. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 96
Part 1: Change From Baseline in Coagulation Parameters [Activated Partial Thromboplastin Time (aPTT)]
기간: Baseline, Weeks 24, 48 and 96
A negative change from baseline indicated a reduction in aPTT.
Baseline, Weeks 24, 48 and 96
Part 1: Change From Baseline in Coagulation Parameters [Prothrombin Time (PT)]
기간: Baseline, Weeks 24, 48 and 96
A negative change from baseline indicated a reduction in PT.
Baseline, Weeks 24, 48 and 96
Part 1: Change From Baseline in Coagulation Parameters [International Normalized Ratio (INR)]
기간: Baseline, Weeks 24, 48 and 96
A negative change from baseline indicated a reduction in clotting time.
Baseline, Weeks 24, 48 and 96
Part 1: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)
기간: Baseline up to Week 96
Parameters included sodium, potassium, chloride, bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, urea nitrogen, creatinine, bicarbonate, calcium, magnesium, phosphate, urate and glucose. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 96
Part 1: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Urinalysis Parameters)
기간: Baseline up to Week 96
Urinalysis included assessments of glucose, ketones, occult blood, protein, specific gravity. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 96
Part 1: Fatigue Score Measured by the Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale
기간: Up to Week 96
The PedsQL multidimensional fatigue questionnaire was answered by the participant (self-assessment) and parent. The fatigue scale contains 18 questions in 3 fatigue dimensions: general fatigue, sleep/rest fatigue and cognitive fatigue. Each item was scored on 5-point Likert scale (0=never to 4=almost always). Each individual score was then reversed (subtracted from 4) and linearly transformed as follows: 0=100, 1=75, 2=50, 3=25, 4=0. For each dimension, total score was calculated as the sum of all the items/number of items answered. A higher total score indicated fewer problems.
Up to Week 96
Part 1: Quality of Life (QOL) as Measured by the PedsQL
기간: Up to Week 96
The PedsQL QOL questionnaire was answered by the participant (self-assessment) and parent. The QoL scale contains 23 questions in 4 dimensions: Physical Functioning, Emotional Fatigue, Social Fatigue and School Fatigue. Each item was scored on 5-point Likert scale (0=never to 4=almost always). Each individual score was then reversed (subtracted from 4) and linearly transformed as follows: 0=100, 1=75, 2=50, 3=25, 4=0. For each dimension, total score was calculated as the sum of all the items/number of items answered. A higher total score indicated better quality of life.
Up to Week 96
Part 1: Change From Baseline in the Expanded Disability Status Scale (EDSS) Score
기간: Baseline, Week 96
The EDSS measures the disability status of participants with multiple sclerosis on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS with higher scores indicating more disability. A negative change from baseline indicated an improvement in the disability.
Baseline, Week 96
Part 2: Annualized Relapse Rate (ARR)
기간: From Baseline (Week 96) up to Week 336
ARR is calculated as the total number of relapses that occurred during the study divided by the total number of participant-years. ARR was analyzed using negative binomial regression model.
From Baseline (Week 96) up to Week 336
Part 2: Change From Baseline in the Expanded Disability Status Scale (EDSS) Score
기간: Baseline (Week 96), Week 336
The EDSS measures the disability status of participants with multiple sclerosis on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. A negative change from baseline indicated an improvement in the disability.
Baseline (Week 96), Week 336
Part 2: Change From Baseline in Brief Visuospatial Memory Test - Revised (BVMT-R) Score
기간: Baseline (Week 96), Weeks 144,192, 240, 288 and 336
BVMT-R is used to assess learning/memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view, and participants render the stimuli via pencil on paper, manual responses. Each design receives from 0 to 2 points, representing accuracy and location. There are three Learning Trials, and the score is reported as the total number of points earned over the trials. Thus, scores range from 0 to 12 per trial; total score range is 0 to 36 for all three trials. Scores were converted to standardized scores using normative data, ranging from 2-86. The lower the score, the more severe the cognitive impairment while higher scores reflect better visuospatial memory.
Baseline (Week 96), Weeks 144,192, 240, 288 and 336
Part 2: Change From Baseline in Symbol Digit Modalities Test (SDMT) Score
기간: Baseline (Week 96), Weeks 144,192, 240, 288 and 336
SDMT is used to assess processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a key, showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110, where higher scores indicate improvement in cognitive functioning and lower scores indicate worsening.
Baseline (Week 96), Weeks 144,192, 240, 288 and 336
Part 2: Number of Participants With or Without School Progression
기간: At Weeks 144, 192, 240, 288 and 336
Participants or caregivers were posed the following question: "During the past year, did [you/the participant] progress from one [class/grade-level] to the next in school?" Responses were recorded as Yes (participant advanced to the next grade) or No (participant did not advance).
At Weeks 144, 192, 240, 288 and 336
Part 2: Change From Baseline in Vital Signs (Temperature)
기간: Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in temperature.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Vital Signs (Pulse Rate)
기간: Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in pulse rate.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Vital Signs (Blood Pressure)
기간: Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in blood pressure.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Vital Signs (Respiratory Rate)
기간: Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in respiratory rate.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Number of Participants With Shifts From Baseline in ECG Abnormalities
기간: From Baseline (Week 96) to Week 336
Clinical significance of abnormalities in ECG was determined based on the investigator's discretion. Shift to abnormal indicated values that were normal or unknown at baseline and shifted to abnormal values post-baseline.
From Baseline (Week 96) to Week 336
Part 2: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)
기간: Baseline (Week 96) up to Week 340
Hematology parameters included leukocytes, erythrocytes, hemoglobin, hematocrit, platelets, eosinophils, lymphocytes, monocytes and neutrophils. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline (Week 96) up to Week 340
Part 2: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)
기간: Baseline (Week 96) up to Week 340
Parameters included potassium, bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, urea nitrogen, creatinine, bicarbonate, calcium, magnesium, phosphate, urate and glucose. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.
Baseline (Week 96) up to Week 340
Part 2: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Urinalysis Parameters)
기간: Baseline up to Week 340
Urinalysis included assessments of erythrocytes, leukocytes and specific gravity. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 340
Part 2: Change From Baseline in Height
기간: Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Weight
기간: Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Bone Age
기간: Baseline (Week 96), Weeks 144, 192 and 240
Bone age was tested until the participant reached a bone age of 16 years.
Baseline (Week 96), Weeks 144, 192 and 240
Part 2: Number of Male Participants by Tanner Stage Assessment
기간: At Weeks 96, 144, 192, 240, 288 and 336
Tanner pubertal staging in males was assessed for testes and scrotum development and pubic hair growth, progressing from stage 1 (prepubertal) to stage 5 (adult). Assessments ended when bone age reached ≥16 years. Testes and scrotum stages were: 1-prepubertal; 2-enlargement of testes, scrotum reddens, texture change; 3-Enlargement of penis, further growth of testes; 4-Increased size of penis with growth in breadth and development of glans; testes and scrotum larger, scrotum skin darker; 5-adult genitalia. Pubic hair stages were: 1-prepubertal; 2-Sparse growth of long, slightly pigmented hair, straight or curled; 3-Darker, coarser and more curled hair, spreading sparsely over junction of pubes; 4-Hair adult in type, but covering smaller area than in adult; no spread to medial surface of thighs; 5-Adult in type and quantity, with horizontal distribution.
At Weeks 96, 144, 192, 240, 288 and 336
Part 2: Number of Female Participants by Tanner Stage Assessment
기간: At Weeks 96, 144, 192, 240, 288 and 336
Tanner pubertal staging in females was assessed for breast development and pubic hair growth, progressing from stage 1 (prepubertal) to stage 5 (adult). Assessments ended when bone age reached ≥16 years or the participant was post-menarche. Breast development stages: 1-prepubertal; 2-breast bud stage with elevation of breast and papilla; enlargement of areola, 3-further enlargement of breast and areola; no separation of their contour; 4-areola and papilla form secondary mound above level of breast; 5-mature stage: projection of papilla only, related to recession of areola. Pubic hair stages: 1-prepubertal (can see velus hair similar to abdominal wall); 2-sparse growth of long, slightly pigmented hair, straight or curled, mainly on labia; 3-Darker, coarser and more curled hair, spreading sparsely over junction of pubes; 4-hair adult in type, but covering smaller area than in adult; no spread to medial surface of thighs; 5-adult in type and quantity, with horizontal distribution.
At Weeks 96, 144, 192, 240, 288 and 336

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스폰서

Biogen

수사관

  • 연구 책임자: Medical Director, Biogen

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 8월 28일

기본 완료 (실제)

2025년 7월 8일

연구 완료 (실제)

2025년 7월 8일

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최초 제출

2014년 11월 3일

QC 기준을 충족하는 최초 제출

2014년 11월 4일

처음 게시됨 (추정된)

2014년 11월 5일

연구 기록 업데이트

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2026년 5월 19일

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2026년 5월 16일

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2026년 5월 1일

추가 정보

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키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 109MS306
  • 2013-002318-11 (EudraCT 번호)

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