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Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol (SONAR-12)

tiistai 18. maaliskuuta 2014 päivittänyt: UCB Pharma SA

An Open-label, Observational 12-week Study to Assess Health-related Quality of Life and Patient-reported Outcomes in Patients With Rheumatoid Arthritis Treated With Certolizumab Pegol

The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis Factor alpha (TNFα) Certolizumab Pegol (CZP).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Yksityiskohtainen kuvaus

An open-label, prospective, and post-authorization observational study. This non-interventional study is designed to establish the importance of the measurement of HRQoL data and patient-reported outcomes in clinical practice in patients with RA, and to assess efficacy and safety use of CZP according to the summary of product characteristics.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

81

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Espanja
      • A Coruña, Espanja
        • 11
      • Barcelona, Espanja
        • 7
      • Barcelona, Espanja
        • 15
      • Barcelona, Espanja
        • 20
      • Barcelona, Espanja
        • 4
      • Girona, Espanja
        • 21
      • Granada, Espanja
        • 9
      • Leon, Espanja
        • 12
      • Lerida, Espanja
        • 18
      • Lérida, Espanja
        • 17
      • Salamanca, Espanja
        • 6
      • Sevilla, Espanja
        • 10
      • Tarragona, Espanja
        • 14
      • Tarragona, Espanja
        • 16
      • Vigo, Espanja
        • 5

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Todennäköisyysnäyte

Tutkimusväestö

Patients with RA who begin therapy with CZP will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the study protocol.

The study will include approximately 105 patients from 20 to 25 sites in Spain.

Kuvaus

Inclusion Criteria:

  • Patient is male or female, aged 18 years or older
  • Patient has active Rheumatoid Arthritis according to American College of Rheumatology (ACR) criteria with duration ≥ 3 months
  • Patient has DAS28 (ESR) > 4.5 and CRP > 1.0 mg/dl at Baseline
  • Patient has failed previous Disease Modifying Anti-Rheumatic Drugs (DMARDs) including Methotrexate treatment
  • Patient has initiated treatment with subcutaneous anti-Tumour Necrosis Factor alpha (anti-TNFα) CZP, administered every 2 weeks
  • Patient has no other prior anti-TNFα treatment (Naïve Patient) or CZP is administered after failure to the first anti-TNFα treatment (First Switch Patient)
  • Patient is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the physician
  • Patient has signed and dated a written informed consent form
  • The patient's treatment must be within the terms of Summary of Product Characteristics (SmPC)

Exclusion Criteria:

  • Patient has a known hypersensitivity to the active substance or to any of the excipients
  • Patient has active Tuberculosis or other severe infections such as Sepsis or Opportunistic Infections
  • Patient has moderate to severe Heart Failure (New York Heart Association (NHYA) classes III/IV)
  • Patient has any medical or psychiatric condition that, in the opinion of the physician, could jeopardize or would compromise the patient's ability to participate in this study or to complete the scheduled questionnaires
  • Pregnant women or women of childbearing potential who are not using adequate contraception to prevent pregnancy

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Certolizumab Pegol treatment
Patients with RA who begin therapy with Certolizumab Pegol (CZP) will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the protocol.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
The HAQ-DI is a measure of function in Rheumatoid Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability.
From Baseline (Week 0) to Week 12
Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)
Aikaikkuna: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)
Aikaikkuna: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)
Aikaikkuna: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).
From Baseline (Week 0) to Week 12
Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
The SF-36 measures the Health Related Quality of Life (HRQoL). It is a 36-item survey that measures eight domains of health. Four of these domains belong to physical health and four domains to mental health. Domain scores are generated from the SF-36. In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).
From Baseline (Week 0) to Week 12
Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
VAS ranges from 0 (no pain) to 100 (worst pain).
From Baseline (Week 0) to Week 12
Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
The DAS28 is used for assessing disease activity in RA. The number of swollen and tender joints will be assessed using 28-joint counts (tender 28 and swollen 28). The ESR is measured in mm/h. In addition the Patient's General Health (GH) is obtained and recorded on a Visual Analog Scale (VAS) of 100 mm. Using this data, the DAS28 [ESR] can be calculated.
From Baseline (Week 0) to Week 12
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
ESR is an inflammatory parameter measured in mm/h.
From Baseline (Week 0) to Week 12
Change from Baseline in the Rheumatoid Factor (RF) at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
RF is an inflammatory parameter measured in International Units (IU)/ml.
From Baseline (Week 0) to Week 12
Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
CRP is an inflammatory parameter measured in mg/l.
From Baseline (Week 0) to Week 12
Change from Baseline in the C3 level at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
C3 is an inflammatory parameter. This measurement includes only subjects for which C3 data are available in the medical history of the subject.
From Baseline (Week 0) to Week 12
Change from Baseline in the C4 level at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
C4 is an inflammatory parameter. This measurement includes only subjects for which C4 data are available in the medical history of the subject.
From Baseline (Week 0) to Week 12
Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12
Aikaikkuna: From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12
Aikaikkuna: From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12
Aikaikkuna: From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12
Aikaikkuna: From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Aikaikkuna: From Week 6 to Week 12
From Week 6 to Week 12
Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
From Baseline (Week 0) to Week 12
Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12
Aikaikkuna: From Week 6 to Week 12
From Week 6 to Week 12
Change from Baseline in global ultrasound index at Week 6
Aikaikkuna: From Baseline (Week 0) to Week 6
Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.
From Baseline (Week 0) to Week 6
Change from Baseline in global ultrasound index at Week 12
Aikaikkuna: From Baseline (Week 0) to Week 12
Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.
From Baseline (Week 0) to Week 12
Number of injection site reactions during the study (up to 16 weeks)
Aikaikkuna: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising.
From Baseline (Week 0) to the end of the Follow-up Period (Week 16)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

UCB Pharma SA

Yhteistyökumppanit

ReSearch Pharmaceutical Services, Inc.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Sunnuntai 1. tammikuuta 2012

Ensisijainen valmistuminen (Todellinen)

Lauantai 1. maaliskuuta 2014

Opintojen valmistuminen (Todellinen)

Lauantai 1. maaliskuuta 2014

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 1. helmikuuta 2012

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 1. helmikuuta 2012

Ensimmäinen Lähetetty (Arvio)

Perjantai 3. helmikuuta 2012

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Keskiviikko 19. maaliskuuta 2014

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 18. maaliskuuta 2014

Viimeksi vahvistettu

Lauantai 1. maaliskuuta 2014

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • RA0053
  • UCB-CER-2010-01

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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