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

10. maj 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

188

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ETN 50mg QW
Biologisk: etanercept
50mg subcutaneous, once weekly, 24 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

13. februar 2015

Først indsendt, der opfyldte QC-kriterier

26. februar 2015

Først opslået (Skøn)

4. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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