Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

4. července 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

402

Fáze

  • Fáze 3

Rozšířený přístup

Dostupný mimo klinické hodnocení. Viz rozšířený záznam o přístupu.

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Certolizumab Pegol
Biologický: Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Ostatní jména:
  • Cimzia

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

UCB Pharma

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2003

Primární dokončení (Aktuální)

1. února 2011

Dokončení studie (Aktuální)

1. února 2011

Termíny zápisu do studia

První předloženo

6. září 2005

První předloženo, které splnilo kritéria kontroly kvality

8. září 2005

První zveřejněno (Odhad)

12. září 2005

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. srpna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. července 2018

Naposledy ověřeno

1. března 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C87015
  • 2005-002617-21 (Číslo EudraCT)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Certolizumab Pegol

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Poland

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit