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

4. Juli 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

402

Phase

  • Phase 3

Erweiterter Zugriff

Verfügbar außerhalb der klinischen Studie. Siehe erweiterter Zugriffsdatensatz.

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Certolizumab Pegol
Biologisch: Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Andere Namen:
  • Cimzia

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

UCB Pharma

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2003

Primärer Abschluss (Tatsächlich)

1. Februar 2011

Studienabschluss (Tatsächlich)

1. Februar 2011

Studienanmeldedaten

Zuerst eingereicht

6. September 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. September 2005

Zuerst gepostet (Schätzen)

12. September 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. August 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juli 2018

Zuletzt verifiziert

1. März 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

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