Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

keskiviikko 10. toukokuuta 2017 päivittänyt: Pfizer

A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis

Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

188

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

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

Opiskelupaikat

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • MHAT Plovdiv
      • Sofia, Bulgaria, 1431
        • DCC "Aleksandrovska" EOOD
      • Sofia, Bulgaria, 1612
        • UMHAT "Sv. Ivan Rilski" EAD, Sofia
      • Stara Zagora, Bulgaria, 6000
        • Medical Center - "New rehabilitation center" EOOD
  • Etelä-Afrikka
    • Cape Town
      • Panorama, Cape Town, Etelä-Afrikka, 7500
        • Panorama Medical Centre
    • Johannesburg
      • Parktown, Johannesburg, Etelä-Afrikka, 2193
        • Wits Clinical Research CMJAH Clinical Trial Site
    • Kwazulu-natal
      • Durban/Berea, Kwazulu-natal, Etelä-Afrikka, 4001
        • St. Augustines Hospital
  • Kreikka
      • Thessaloniki, Kreikka, 56429
        • Rheumatology Unit
    • Achaia
      • Rion Patras, Achaia, Kreikka, 26500
        • Rheumatology department
    • Crete
      • Heraklion, Crete, Kreikka, 71110
        • University Hospital of Heraklion
  • Kroatia
      • Rijeka, Kroatia, 51000
        • CHC Rijeka
      • Zagreb, Kroatia, 10000
        • Medicinski Centar Kuna Peric
  • Puola
      • Krakow, Puola, 31-501
        • Krakowskie Centrum Medyczne sp. Z.O.O
      • Nadarzyn, Puola, 05-830
        • NZOZ Lecznica MAK-MED s.c.
      • Poznan, Puola, 61-397
        • Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
      • Warszawa, Puola, 02-691
        • Reumatika-Centrum Reumatologii
  • Saksa
      • Berlin, Saksa, 14059
        • Schlosspark-Klinik, Innere Medizin II, Rheumatologie
      • Hannover, Saksa, 30625
        • Medizinische Hochschule Hannover
      • Vogelsang-Gommern, Saksa, 39245
        • Immunologisches Zentrum Vogelsang-Gommern GmbH
    • Hessen
      • Frankfurt/Main, Hessen, Saksa, 60528
        • Centrum für innovative Diagnostik und Therapie
    • Nordrhein-westfalen
      • Ratingen, Nordrhein-westfalen, Saksa, 40882
        • Rheumaforschung - Studienambulanz Dr. Wassenberg
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Institute of Rheumatology
  • Slovakia
      • Bratislava, Slovakia, 841 04
        • Reumatologicka ambulancia
      • Dunajska Streda, Slovakia, 929 01
        • AAGS, s.r.o.
      • Poprad, Slovakia, 058 01
        • Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.
      • Rimavska Sobota, Slovakia, 979 01
        • Reumex S.R.O.
      • Trnava, Slovakia, 917 01
        • REUMA-GLOBAL s.r.o.
      • Zilina, Slovakia, 010 01
        • Reumatologicka ambulancia
  • Unkari
      • Budapest, Unkari, 1036
        • Qualiclinic Kft.
      • Kistarcsa, Unkari, 2143
        • Pest Megyei Flor Ferenc Korhaz
      • Nyiregyhaza, Unkari, 4400
        • Szabolcs-Szatmar-Bereg megyei

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

Kuvaus

Inclusion Criteria:

  • Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
  • Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.

Exclusion Criteria:

  • Prior treatment with etanercept.
  • Presence of active infection or active or untreated tuberculosis.

Opintosuunnitelma

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

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: ETN 50mg QW
Biologinen: etanercept
50mg subcutaneous, once weekly, 24 weeks

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
Aikaikkuna: Week 12
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Week 12
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
Aikaikkuna: Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Week 24
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
Aikaikkuna: Baseline up to Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Baseline up to Week 24

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
Aikaikkuna: Baseline (Day 1) up to Week 24
Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.
Baseline (Day 1) up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Aikaikkuna: Baseline (Day 1) up to Week 28 (Follow-up)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Investigator-Identified Serious Infections
Aikaikkuna: Baseline (Day 1) up to Week 28 (Follow-up)
Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Injection Site Reactions
Aikaikkuna: Baseline (Day 1) up to Week 28 (Follow-up)
Injection site reactions included injection site erythema, swelling, pain and warmth.
Baseline (Day 1) up to Week 28 (Follow-up)
Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities
Aikaikkuna: Baseline (Day 1) up to Week 28 (Follow-up)
Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).
Baseline (Day 1) up to Week 28 (Follow-up)
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Aikaikkuna: Week 4, 12, 24
ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.
Week 4, 12, 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Aikaikkuna: Week 4, 12, 24
ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.
Week 4, 12, 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Aikaikkuna: Week 4, 12, 24
ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.
Week 4, 12, 24
Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
Aikaikkuna: Baseline, Week 4, 12, 24
DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
Baseline, Week 4, 12, 24
Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
Aikaikkuna: Baseline, Week 4, 12, 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.
Baseline, Week 4, 12, 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
Aikaikkuna: Baseline, Week 4, 12, 24
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Baseline, Week 4, 12, 24

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

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

Keskiviikko 1. huhtikuuta 2015

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. toukokuuta 2016

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. kesäkuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 13. helmikuuta 2015

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 26. helmikuuta 2015

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 4. maaliskuuta 2015

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 15. toukokuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 10. toukokuuta 2017

Viimeksi vahvistettu

Keskiviikko 1. maaliskuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • B1801359
  • 2013-004569-16 (EudraCT-numero)

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 .

Tilaa