Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
2018년 7월 10일 업데이트: UCB Pharma
Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
연구 개요
연구 유형
중재적
등록 (실제)
539
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
-
-
-
Amsterdam, 네덜란드
-
Eindhoven, 네덜란드
-
Enschede, 네덜란드
-
Heerlen, 네덜란드
-
Leiden, 네덜란드
-
Terneuven, 네덜란드
-
Zwolle, 네덜란드
-
-
-
-
-
Oslo, 노르웨이
-
Tromso, 노르웨이
-
-
-
-
-
Aalborg, 덴마크
-
Arhus, 덴마크
-
Copenhagen, 덴마크
-
Herlev, 덴마크
-
-
-
-
-
Berlin, 독일
-
Hamburg, 독일
-
Hannover, 독일
-
Herne, 독일
-
Kiel, 독일
-
Leipzig, 독일
-
Minden, 독일
-
Munchen, 독일
-
Munich, 독일
-
-
-
-
California
-
San Francisco, California, 미국
-
-
Florida
-
Gainesville, Florida, 미국
-
-
Georgia
-
Atlanta, Georgia, 미국
-
-
Illinois
-
Chicago, Illinois, 미국
-
-
Indiana
-
Indianapolis, Indiana, 미국
-
-
Kentucky
-
Lexington, Kentucky, 미국
-
Louisville, Kentucky, 미국
-
-
Louisiana
-
Baton Rouge, Louisiana, 미국
-
-
Maryland
-
Baltimore, Maryland, 미국
-
-
Massachusetts
-
Boston, Massachusetts, 미국
-
-
Minnesota
-
Rochester, Minnesota, 미국
-
-
Nebraska
-
Lincoln, Nebraska, 미국
-
-
New York
-
Great Neck, New York, 미국
-
New York, New York, 미국
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국
-
Charlotte, North Carolina, 미국
-
-
Ohio
-
Cincinnati, Ohio, 미국
-
Cleveland, Ohio, 미국
-
-
Oklahoma
-
Oklahoma City, Oklahoma, 미국
-
-
Oregon
-
Portland, Oregon, 미국
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국
-
Pittsburgh, Pennsylvania, 미국
-
-
South Carolina
-
Charleston, South Carolina, 미국
-
-
Tennessee
-
Germantown, Tennessee, 미국
-
Kingsport, Tennessee, 미국
-
Nashville, Tennessee, 미국
-
-
Texas
-
Dallas, Texas, 미국
-
Galveston, Texas, 미국
-
Houston, Texas, 미국
-
-
Washington
-
Seattle, Washington, 미국
-
-
Wisconsin
-
Milwaukee, Wisconsin, 미국
-
-
-
-
-
Bonheiden, 벨기에
-
Brussels, 벨기에
-
Genk, 벨기에
-
Gent, 벨기에
-
Kortrijk, 벨기에
-
Leuven, 벨기에
-
Liege, 벨기에
-
Roeselare, 벨기에
-
-
-
-
-
Goteborg, 스웨덴
-
Malmo, 스웨덴
-
Orebro, 스웨덴
-
Stockholm, 스웨덴
-
-
-
-
-
Basel, 스위스
-
Bern, 스위스
-
Lausanne, 스위스
-
-
-
-
-
Barcelona, 스페인
-
Madrid, 스페인
-
Oviedo, 스페인
-
Santiago De Compostela, 스페인
-
Sevilla, 스페인
-
Valencia, 스페인
-
-
-
-
-
Bristol, 영국
-
Cambridge, 영국
-
Edinburgh, 영국
-
London, 영국
-
Nottingham, 영국
-
Oxford, 영국
-
Sheffield, 영국
-
-
-
-
-
Innsbruck, 오스트리아
-
Oberpullendorf, 오스트리아
-
Wien, 오스트리아
-
-
-
-
-
Bari, 이탈리아
-
Bologna, 이탈리아
-
Milano, 이탈리아
-
Padova, 이탈리아
-
Palermo, 이탈리아
-
Roma, 이탈리아
-
Torino, 이탈리아
-
-
-
-
-
Calgary, 캐나다
-
-
Alberta
-
Edmonton, Alberta, 캐나다
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다
-
-
Ontario
-
London, Ontario, 캐나다
-
Richmond, Ontario, 캐나다
-
Toronto, Ontario, 캐나다
-
-
-
-
-
Amiens, 프랑스
-
Clichy, 프랑스
-
Grenoble, Cedex 9, 프랑스
-
Lille, 프랑스
-
Montpellier, Cédex 5, 프랑스
-
Nice, 프랑스, Cedex 3
-
Paris, 프랑스
-
Pessac, 프랑스
-
Rouen, 프랑스
-
Toulouse, Cedex 9, 프랑스
-
-
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:
- Subjects with Crohn's Disease
- Previous treatment failure to Infliximab (intolerance and/or no response)
Exclusion Criteria:
- Obstructive intestinal strictures
- Recent bowel resection
- Proctocolectomy or total colectomy
- Current total parenteral nutrition
- Short bowel syndrome
- All concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Active 1
Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol |
400mg Certolizumab Pegol, Q4W, administered 4-weekly
다른 이름들:
400mg Certolizumab Pegol, Q2W, administered 2-weekly
다른 이름들:
placebo administered 4-weekly in Active 1
|
|
실험적: Active 2
Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol |
400mg Certolizumab Pegol, Q4W, administered 4-weekly
다른 이름들:
400mg Certolizumab Pegol, Q2W, administered 2-weekly
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
기간: Baseline to Week 6
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. |
Baseline to Week 6
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
기간: Baseline to Week 26
|
Response is defined as at least 100 point decrease in CDAI score from baseline.
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 26
|
|
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
기간: Baseline to Week 6
|
Response is defined as at least 70 points reduction in CDAI score.
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 6
|
|
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
기간: Baseline to Week 26
|
Response is defined as at least 70 points reduction in CDAI score.
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 26
|
|
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
기간: Week 6
|
Remission is defined as CDAI score ≤ 150.
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 6
|
|
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
기간: Week 26
|
Remission is defined as CDAI score ≤ 150.
The CDAI score is used to quantify the symptoms with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 26
|
|
CDAI Score at Week 2 of the Induction Phase
기간: Week 2
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 2
|
|
CDAI Score at Week 4 of the Induction Phase
기간: Week 4
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 4
|
|
CDAI Score at Week 6 of the Induction Phase
기간: Week 6
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 6
|
|
CDAI Score at Week 8 in the Randomized Maintenance Phase
기간: Week 8
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 8
|
|
CDAI Score at Week 10 in the Randomized Maintenance Phase
기간: Week 10
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 10
|
|
CDAI Score at Week 12 in the Randomized Maintenance Phase
기간: Week 12
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 12
|
|
CDAI Score at Week 14 in the Randomized Maintenance Phase
기간: Week 14
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 14
|
|
CDAI Score at Week 16 in the Randomized Maintenance Phase
기간: Week 16
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 16
|
|
CDAI Score at Week 18 in the Randomized Maintenance Phase
기간: Week 18
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 18
|
|
CDAI Score at Week 20 in the Randomized Maintenance Phase
기간: Week 20
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 20
|
|
CDAI Score at Week 22 in the Randomized Maintenance Phase
기간: Week 22
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 22
|
|
CDAI Score at Week 24 in the Randomized Maintenance Phase
기간: Week 24
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 24
|
|
CDAI Score at Week 26 in the Randomized Maintenance Phase
기간: Week 26
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Week 26
|
|
Change From Baseline in CDAI Score at Week 2 of the Induction Phase
기간: Baseline to Week 2
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 2
|
|
Change From Baseline in CDAI Score at Week 4 of the Induction Phase
기간: Baseline to Week 4
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 4
|
|
Change From Baseline in CDAI Score at Week 6 of the Induction Phase
기간: Baseline to Week 6
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 6
|
|
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
기간: Baseline to Week 8
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 8
|
|
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
기간: Baseline to Week 10
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 10
|
|
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
기간: Baseline to Week 12
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 12
|
|
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
기간: Baseline to Week 14
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 14
|
|
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
기간: Baseline to Week 16
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 16
|
|
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
기간: Baseline to Week 18
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 18
|
|
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
기간: Baseline to Week 20
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 20
|
|
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
기간: Baseline to Week 22
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 22
|
|
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
기간: Baseline to Week 24
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 24
|
|
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
기간: Baseline to Week 26
|
The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
|
Baseline to Week 26
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 10
|
Remission is defined as CDAI score ≤ 150.
|
Week 10
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 12
|
Remission is defined as CDAI score ≤ 150.
|
Week 12
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 14
|
Remission is defined as CDAI score ≤ 150.
|
Week 14
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 16
|
Remission is defined as CDAI score ≤ 150.
|
Week 16
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 18
|
Remission is defined as CDAI score ≤ 150.
|
Week 18
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 20
|
Remission is defined as CDAI score ≤ 150.
|
Week 20
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 22
|
Remission is defined as CDAI score ≤ 150.
|
Week 22
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 24
|
Remission is defined as CDAI score ≤ 150.
|
Week 24
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 26
|
Remission is defined as CDAI score ≤ 150.
|
Week 26
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 10
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 10
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 12
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 12
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 14
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 14
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 16
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 16
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 18
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 18
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 20
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 20
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 22
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 22
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 24
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 24
|
|
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
기간: Week 26
|
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
|
Week 26
|
|
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
기간: Week 0
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 0
|
|
CRP Level at Week 2 of the Induction Phase
기간: Week 2
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 2
|
|
CRP Level at Week 4 of the Induction Phase
기간: Week 4
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 4
|
|
CRP Level at Week 6 of the Induction Phase
기간: Week 6
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 6
|
|
CRP Level at Week 8 in the Randomized Maintenance Phase
기간: Week 8
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 8
|
|
CRP Level at Week 10 in the Randomized Maintenance Phase
기간: Week 10 (optional measurement)
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 10 (optional measurement)
|
|
CRP Level at Week 12 in the Randomized Maintenance Phase
기간: Week 12
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 12
|
|
CRP Level at Week 14 in the Randomized Maintenance Phase
기간: Week 14 (optional measurement)
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 14 (optional measurement)
|
|
CRP Level at Week 16 in the Randomized Maintenance Phase
기간: Week 16
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 16
|
|
CRP Level at Week 18 in the Randomized Maintenance Phase
기간: Week 18 (optional measurement)
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 18 (optional measurement)
|
|
CRP Level at Week 20 in the Randomized Maintenance Phase
기간: Week 20
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 20
|
|
CRP Level at Week 22 in the Randomized Maintenance Phase
기간: Week 22 (optional measurement)
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 22 (optional measurement)
|
|
CRP Level at Week 24 in the Randomized Maintenance Phase
기간: Week 24
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 24
|
|
CRP Level at Week 26 in the Randomized Maintenance Phase
기간: Week 26
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
|
Week 26
|
|
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
기간: Last visit on or before Week 26
|
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.
|
Last visit on or before Week 26
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
기간: Week 6 to Week 26
|
Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event.
Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.
|
Week 6 to Week 26
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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
- Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.
- Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.
- Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
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
2006년 4월 1일
기본 완료 (실제)
2008년 4월 1일
연구 완료 (실제)
2008년 4월 1일
연구 등록 날짜
최초 제출
2006년 3월 28일
QC 기준을 충족하는 최초 제출
2006년 3월 28일
처음 게시됨 (추정)
2006년 3월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 10일
마지막으로 확인됨
2011년 4월 1일
추가 정보
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. .