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

4 luglio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

402

Fase

  • Fase 3

Accesso esteso

A disposizione al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Certolizumab Pegol
Biologico: Certolizumab Pegol
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Altri nomi:
  • Cimzia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

UCB Pharma

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2003

Completamento primario (Effettivo)

1 febbraio 2011

Completamento dello studio (Effettivo)

1 febbraio 2011

Date di iscrizione allo studio

Primo inviato

6 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

8 settembre 2005

Primo Inserito (Stima)

12 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 luglio 2018

Ultimo verificato

1 marzo 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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