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Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

2018년 7월 4일 업데이트: UCB Pharma

A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis

The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

402

단계

  • 3단계

확장된 액세스

사용 가능 임상시험 외. 확장 액세스 기록을 참조하세요.

연락처 및 위치

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

연구 장소

  • 독일
      • Berlin, 독일
      • Gortlitz, 독일
      • Hamburg, 독일
      • Jena, 독일
      • Koln, 독일
      • Leipzig, 독일
      • Ratingen, 독일
  • 미국
    • Alabama
      • Huntsville, Alabama, 미국
    • Arizona
      • Paradise Valley, Arizona, 미국
    • District of Columbia
      • Washington, District of Columbia, 미국
    • Florida
      • Aventura, Florida, 미국
      • Clearwater, Florida, 미국
      • Ocala, Florida, 미국
      • Orlando, Florida, 미국
      • Tampa, Florida, 미국
    • Idaho
      • Coeur d'Alene, Idaho, 미국
    • Illinois
      • Springfield, Illinois, 미국
    • Kansas
      • Wichita, Kansas, 미국
    • Maryland
      • Wheaton, Maryland, 미국
    • Massachusetts
      • Fall River, Massachusetts, 미국
    • Missouri
      • Saint Louis, Missouri, 미국
    • Nebraska
      • Lincoln, Nebraska, 미국
    • North Carolina
      • Charlotte, North Carolina, 미국
    • Ohio
      • Cleveland, Ohio, 미국
      • Dayton, Ohio, 미국
    • Pennsylvania
      • Erie, Pennsylvania, 미국
      • West Reading, Pennsylvania, 미국
    • South Carolina
      • Charleston, South Carolina, 미국
    • Tennessee
      • Memphis, Tennessee, 미국
    • Texas
      • Austin, Texas, 미국
      • Dallas, Texas, 미국
      • Duncanville, Texas, 미국
      • Lubbock, Texas, 미국
      • San Antonio, Texas, 미국
      • San Diego, Texas, 미국
    • Washington
      • Everett, Washington, 미국
  • 벨기에
      • Antwerpen, 벨기에
      • Diepenbeek, 벨기에
      • Liege, 벨기에
      • Merksem, 벨기에
  • 아일랜드
      • Dublin, 아일랜드
      • Waterford, 아일랜드
  • 영국
      • Birmingham, 영국
      • Cannock, 영국
      • Colchester, 영국
      • Glasgow, 영국
      • Harrogate, 영국
      • London, 영국
      • Manchester, 영국
      • Oxford, 영국
      • Peterborough, 영국
      • Wirral, 영국
  • 오스트리아
      • Graz, 오스트리아
      • Klagenfurt, 오스트리아
      • Vienna, 오스트리아
  • 체코
      • Ceske Budejovice, 체코
      • Liberec, 체코
      • Ostrava Trebovice, 체코
      • Prague 2, 체코
      • Praha4 -krc, 체코
      • Uherske Hradiste, 체코

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:

  • Participation in CZP trial C87014 or C87011
  • If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
  • Must have provided written informed consent before undergoing any study procedures

Exclusion Criteria:

  • History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
  • Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
  • Any finding indicative of Tuberculosis at end of previous study
  • Known HIV infection
  • Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal)
  • Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 %
  • Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm^3)
  • Platelet count < 100 x 100 L (100,000/mm^3)
  • Serum creatinine > 1.5 times upper limit of normal based on patient age and sex
  • Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
  • Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
  • Any other condition which the Principal Investigator judges would make patient unsuitable for study participation

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: Certolizumab Pegol
생물학적: Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
다른 이름들:
  • 심지아

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
기간: From first dose of CZP up to 8 years

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo.
From first dose of CZP up to 8 years
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years
기간: From First Visit (Week 0 in this study) up to 8 years

An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
From First Visit (Week 0 in this study) up to 8 years

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52
기간: From Baseline to Week 52

The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
From Baseline to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100
기간: From Baseline to Week 100

The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
From Baseline to Week 100
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160
기간: From Baseline to Week 160

The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
From Baseline to Week 160
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208
기간: From Baseline to Week 208

The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
From Baseline to Week 208
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256
기간: From Baseline to Week 256

The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
From Baseline to Week 256
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316
기간: From Baseline to Week 316

The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

Baseline is Baseline of the respective feeder study.
From Baseline to Week 316
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit
기간: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit
기간: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit
기간: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit
기간: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years
기간: From First Visit (Week 0 in this study) up to 8 years
From First Visit (Week 0 in this study) up to 8 years
Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years
기간: From First Visit (Week 0 in this study) up to 8 years
This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.
From First Visit (Week 0 in this study) up to 8 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

UCB Pharma

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

유용한 링크

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

2003년 3월 1일

기본 완료 (실제)

2011년 2월 1일

연구 완료 (실제)

2011년 2월 1일

연구 등록 날짜

최초 제출

2005년 9월 6일

QC 기준을 충족하는 최초 제출

2005년 9월 8일

처음 게시됨 (추정)

2005년 9월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 8월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 7월 4일

마지막으로 확인됨

2018년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • C87015
  • 2005-002617-21 (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. .

구독하다