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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

2017년 5월 10일 업데이트: Pfizer

A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis

Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

188

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 그리스
      • Thessaloniki, 그리스, 56429
        • Rheumatology Unit
    • Achaia
      • Rion Patras, Achaia, 그리스, 26500
        • Rheumatology department
    • Crete
      • Heraklion, Crete, 그리스, 71110
        • University Hospital of Heraklion
  • 남아프리카
    • Cape Town
      • Panorama, Cape Town, 남아프리카, 7500
        • Panorama Medical Centre
    • Johannesburg
      • Parktown, Johannesburg, 남아프리카, 2193
        • Wits Clinical Research CMJAH Clinical Trial Site
    • Kwazulu-natal
      • Durban/Berea, Kwazulu-natal, 남아프리카, 4001
        • St. Augustines Hospital
  • 독일
      • Berlin, 독일, 14059
        • Schlosspark-Klinik, Innere Medizin II, Rheumatologie
      • Hannover, 독일, 30625
        • Medizinische Hochschule Hannover
      • Vogelsang-Gommern, 독일, 39245
        • Immunologisches Zentrum Vogelsang-Gommern GmbH
    • Hessen
      • Frankfurt/Main, Hessen, 독일, 60528
        • Centrum für innovative Diagnostik und Therapie
    • Nordrhein-westfalen
      • Ratingen, Nordrhein-westfalen, 독일, 40882
        • Rheumaforschung - Studienambulanz Dr. Wassenberg
  • 불가리아
      • Plovdiv, 불가리아, 4000
        • MHAT Plovdiv
      • Sofia, 불가리아, 1431
        • DCC "Aleksandrovska" EOOD
      • Sofia, 불가리아, 1612
        • UMHAT "Sv. Ivan Rilski" EAD, Sofia
      • Stara Zagora, 불가리아, 6000
        • Medical Center - "New rehabilitation center" EOOD
  • 세르비아
    • Beograd
      • Belgrade, Beograd, 세르비아, 11000
        • Institute of Rheumatology
  • 슬로바키아
      • Bratislava, 슬로바키아, 841 04
        • Reumatologicka ambulancia
      • Dunajska Streda, 슬로바키아, 929 01
        • AAGS, s.r.o.
      • Poprad, 슬로바키아, 058 01
        • Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.
      • Rimavska Sobota, 슬로바키아, 979 01
        • REUMEX s.r.o.
      • Trnava, 슬로바키아, 917 01
        • REUMA-GLOBAL s.r.o.
      • Zilina, 슬로바키아, 010 01
        • Reumatologicka ambulancia
  • 크로아티아
      • Rijeka, 크로아티아, 51000
        • CHC Rijeka
      • Zagreb, 크로아티아, 10000
        • Medicinski Centar Kuna Peric
  • 폴란드
      • Krakow, 폴란드, 31-501
        • Krakowskie Centrum Medyczne sp. Z.O.O
      • Nadarzyn, 폴란드, 05-830
        • NZOZ Lecznica MAK-MED s.c.
      • Poznan, 폴란드, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
      • Warszawa, 폴란드, 02-691
        • Reumatika-Centrum Reumatologii
  • 헝가리
      • Budapest, 헝가리, 1036
        • Qualiclinic Kft.
      • Kistarcsa, 헝가리, 2143
        • Pest Megyei Flor Ferenc Korhaz
      • Nyiregyhaza, 헝가리, 4400
        • Szabolcs-Szatmar-Bereg megyei

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
  • Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.

Exclusion Criteria:

  • Prior treatment with etanercept.
  • Presence of active infection or active or untreated tuberculosis.

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ETN 50mg QW
생물학적: etanercept
50mg subcutaneous, once weekly, 24 weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
기간: Week 12
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Week 12
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
기간: Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Week 24
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
기간: Baseline up to Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Baseline up to Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
기간: Baseline (Day 1) up to Week 24
Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.
Baseline (Day 1) up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Baseline (Day 1) up to Week 28 (Follow-up)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Investigator-Identified Serious Infections
기간: Baseline (Day 1) up to Week 28 (Follow-up)
Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Injection Site Reactions
기간: Baseline (Day 1) up to Week 28 (Follow-up)
Injection site reactions included injection site erythema, swelling, pain and warmth.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities
기간: Baseline (Day 1) up to Week 28 (Follow-up)
Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).
Baseline (Day 1) up to Week 28 (Follow-up)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
기간: Week 4, 12, 24
ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.
Week 4, 12, 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
기간: Week 4, 12, 24
ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.
Week 4, 12, 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
기간: Week 4, 12, 24
ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.
Week 4, 12, 24
Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
기간: Baseline, Week 4, 12, 24
DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
Baseline, Week 4, 12, 24
Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
기간: Baseline, Week 4, 12, 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
Baseline, Week 4, 12, 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
기간: Baseline, Week 4, 12, 24
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Baseline, Week 4, 12, 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2015년 4월 1일

기본 완료 (실제)

2016년 5월 1일

연구 완료 (실제)

2016년 6월 1일

연구 등록 날짜

최초 제출

2015년 2월 13일

QC 기준을 충족하는 최초 제출

2015년 2월 26일

처음 게시됨 (추정)

2015년 3월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 5월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 5월 10일

마지막으로 확인됨

2017년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B1801359
  • 2013-004569-16 (EudraCT 번호)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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