이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)

2019년 5월 20일 업데이트: Novartis Pharmaceuticals

A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

460

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 독일
      • Aachen, 독일, 52064
        • Novartis Investigative Site
      • Erlangen, 독일, 91054
        • Novartis Investigative Site
      • Erlangen, 독일, 91056
        • Novartis Investigative Site
      • Gommern, 독일, 39245
        • Novartis Investigative Site
      • Hamburg, 독일, 22415
        • Novartis Investigative Site
      • Hildesheim, 독일, 31134
        • Novartis Investigative Site
      • Koeln, 독일, 50937
        • Novartis Investigative Site
      • Leipzig, 독일, 04103
        • Novartis Investigative Site
      • Nürnberg, 독일, 90429
        • Novartis Investigative Site
      • Ratingen, 독일, 40878
        • Novartis Investigative Site
      • Zerbst, 독일, 39261
        • Novartis Investigative Site
  • 러시아 연방
      • Ekaterinburg, 러시아 연방, 620109
        • Novartis Investigative Site
      • Ekaterinburg, 러시아 연방, 620028
        • Novartis Investigative Site
      • Kemerovo, 러시아 연방, 650029
        • Novartis Investigative Site
      • Moscow, 러시아 연방, 115522
        • Novartis Investigative Site
      • St Petersburg, 러시아 연방, 190068
        • Novartis Investigative Site
      • Yaroslavl, 러시아 연방, 150003
        • Novartis Investigative Site
  • 미국
    • Alabama
      • Anniston, Alabama, 미국, 36207-5710
        • Novartis Investigative Site
    • Arizona
      • Mesa, Arizona, 미국, 85202
        • Novartis Investigative Site
      • Paradise Valley, Arizona, 미국, 85253
        • Novartis Investigative Site
    • California
      • Upland, California, 미국, 91786
        • Novartis Investigative Site
    • Florida
      • Tamarac, Florida, 미국, 33321
        • Novartis Investigative Site
    • Minnesota
      • Eagan, Minnesota, 미국, 55121
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, 미국, 63117
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, 미국, 68516
        • Novartis Investigative Site
    • New Jersey
      • Freehold, New Jersey, 미국, 07728
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, 미국, 28210
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73103
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, 미국, 16635
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, 미국, 29460
        • Novartis Investigative Site
      • Columbia, South Carolina, 미국, 29204
        • Novartis Investigative Site
    • Tennessee
      • Jackson, Tennessee, 미국, 38305
        • Novartis Investigative Site
    • Texas
      • Benbrook, Texas, 미국, 76126
        • Novartis Investigative Site
      • Dallas, Texas, 미국, 75216
        • Novartis Investigative Site
      • Dallas, Texas, 미국, 75246
        • Novartis Investigative Site
      • Houston, Texas, 미국, 77074
        • Novartis Investigative Site
      • League City, Texas, 미국, 77573
        • Novartis Investigative Site
      • Mesquite, Texas, 미국, 75150
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, 미국, 98122
        • Novartis Investigative Site
  • 벨기에
      • Genk, 벨기에, 3600
        • Novartis Investigative Site
      • Gent, 벨기에, 9000
        • Novartis Investigative Site
      • Leuven, 벨기에, 3000
        • Novartis Investigative Site
  • 불가리아
      • Pleven, 불가리아, 5800
        • Novartis Investigative Site
      • Sofia, 불가리아, 1612
        • Novartis Investigative Site
    • Gabrovo
      • Sevlievo, Gabrovo, 불가리아, 5400
        • Novartis Investigative Site
  • 브라질
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, 브라질, 90610-000
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, 브라질, 04023-900
        • Novartis Investigative Site
      • Sao Paulo, SP, 브라질, 04266 010
        • Novartis Investigative Site
  • 슬로바키아
      • Lucenec, 슬로바키아, 984 01
        • Novartis Investigative Site
  • 싱가포르
      • Singapore, 싱가포르, 119074
        • Novartis Investigative Site
      • Singapore, 싱가포르, 529889
        • Novartis Investigative Site
      • Singapore, 싱가포르, 169608
        • Novartis Investigative Site
  • 아르헨티나
      • Buenos Aires, 아르헨티나, C1417EYG
        • Novartis Investigative Site
      • Caba, 아르헨티나, C1419AHN
        • Novartis Investigative Site
      • Cordoba, 아르헨티나, X5016KEH
        • Novartis Investigative Site
      • Córdoba, 아르헨티나, X5000EDC
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, 아르헨티나, C1181ACH
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, 아르헨티나, S2000CFJ
        • Novartis Investigative Site
  • 영국
      • Glasgow, 영국, G31 2ER
        • Novartis Investigative Site
      • London, 영국, SE1 9RT
        • Novartis Investigative Site
    • London
      • Leytonstone, London, 영국, E11 1NR
        • Novartis Investigative Site
    • Staffordshire
      • Cannock, Staffordshire, 영국, WS11 2XY
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, 영국, BD5 0NA
        • Novartis Investigative Site
  • 이스라엘
      • Ashkelon, 이스라엘, 78278
        • Novartis Investigative Site
      • Haifa, 이스라엘, 3339419
        • Novartis Investigative Site
      • Ramat Gan, 이스라엘, 5265601
        • Novartis Investigative Site
      • Tel Aviv, 이스라엘, 6423906
        • Novartis Investigative Site
  • 이탈리아
    • CT
      • Catania, CT, 이탈리아, 95100
        • Novartis Investigative Site
    • PO
      • Prato, PO, 이탈리아, 59100
        • Novartis Investigative Site
    • SI
      • Siena, SI, 이탈리아, 53100
        • Novartis Investigative Site
    • VR
      • Verona, VR, 이탈리아, 37134
        • Novartis Investigative Site
  • 체코
    • Czech Republic
      • Bruntal, Czech Republic, 체코, 792 01
        • Novartis Investigative Site
      • Uherske Hradiste, Czech Republic, 체코, 686 01
        • Novartis Investigative Site
      • Zlin, Czech Republic, 체코, 760 01
        • Novartis Investigative Site
  • 캐나다
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, 캐나다, A1C 5B8
        • Novartis Investigative Site
      • St. John's, Newfoundland and Labrador, 캐나다, A1A 5E8
        • Novartis Investigative Site
    • Ontario
      • Newmarket, Ontario, 캐나다, L3Y 3R7
        • Novartis Investigative Site
      • Waterloo, Ontario, 캐나다, N2J 1C4
        • Novartis Investigative Site
    • Quebec
      • Trois-Rivieres, Quebec, 캐나다, G8Z 1Y2
        • Novartis Investigative Site
  • 태국
      • Bangkok, 태국, 10400
        • Novartis Investigative Site
      • Chiang Mai, 태국, 50200
        • Novartis Investigative Site
    • THA
      • Khon Kaen, THA, 태국, 40002
        • Novartis Investigative Site
  • 폴란드
      • Bialystok, 폴란드, 15-351
        • Novartis Investigative Site
      • Warszawa, 폴란드, 02-341
        • Novartis Investigative Site
  • 필리핀 제도
      • Las Pinas, 필리핀 제도, 1740
        • Novartis Investigative Site
      • Manila, 필리핀 제도, 1003
        • Novartis Investigative Site
      • Manila, 필리핀 제도, 1008
        • Novartis Investigative Site
      • Quezon City, 필리핀 제도, 1102
        • Novartis Investigative Site
      • Quezon City, 필리핀 제도, 1118
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, 필리핀 제도, 4217
        • Novartis Investigative Site
    • Cavite
      • Dasmarinas, Cavite, 필리핀 제도, 4114
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, 필리핀 제도, 1003
        • Novartis Investigative Site
  • 호주
    • Queensland
      • Maroochydore, Queensland, 호주, 4558
        • Novartis Investigative Site
    • Victoria
      • Malvern East, Victoria, 호주, 3145
        • Novartis Investigative Site

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 must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
  • Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
  • Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion criteria

  • Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
  • Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)

Other protocol-defined inclusion/exclusion criteria may apply

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: Secukinumab 75mg
Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
의약품: Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
다른 이름들:
  • AIN457
실험적: Secukinumab 150mg
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
의약품: Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
다른 이름들:
  • AIN457
실험적: Placebo - AIN457A 75mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg
의약품: 위약
위약
다른 이름들:
  • 위약 - AIN457A
의약품: Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
다른 이름들:
  • AIN457
실험적: Placebo - AIN457 150mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg
의약품: 위약
위약
다른 이름들:
  • 위약 - AIN457A
의약품: Secukinumab
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
다른 이름들:
  • AIN457

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260

Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

  • Patient's assessment of Psoriatic Arthritis (PsA) pain
  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR50
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260

Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

  • Patient's assessment of PsA pain
  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR70
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260

Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain

  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260

Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.

Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Change From Baseline in Disease Activity Score-CRP (DAS28)
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260

Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores.

DAS28 is a combined measure of disease activity based on the following formula:

DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of Subjects Achieving Low Disease Activity
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
기간: weeks 116, 128, 140, 156, 180, 208, 232 and 260
Percentage of subjects achieving disease remission (DAS28<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
weeks 116, 128, 140, 156, 180, 208, 232 and 260

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

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 (실제)

2013년 9월 30일

기본 완료 (실제)

2018년 1월 11일

연구 완료 (실제)

2018년 1월 11일

연구 등록 날짜

최초 제출

2013년 7월 1일

QC 기준을 충족하는 최초 제출

2013년 7월 1일

처음 게시됨 (추정)

2013년 7월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 6월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 5월 20일

마지막으로 확인됨

2019년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CAIN457F2306E1
  • 2013-001241-13 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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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