- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02378506
Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
10. mai 2017 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
188
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Plovdiv, Bulgaria, 4000
- MHAT Plovdiv
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Sofia, Bulgaria, 1431
- DCC "Aleksandrovska" EOOD
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Sofia, Bulgaria, 1612
- UMHAT "Sv. Ivan Rilski" EAD, Sofia
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Stara Zagora, Bulgaria, 6000
- Medical Center - "New rehabilitation center" EOOD
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Thessaloniki, Hellas, 56429
- Rheumatology Unit
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Achaia
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Rion Patras, Achaia, Hellas, 26500
- Rheumatology department
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Crete
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Heraklion, Crete, Hellas, 71110
- University Hospital of Heraklion
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Rijeka, Kroatia, 51000
- CHC Rijeka
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Zagreb, Kroatia, 10000
- Medicinski Centar Kuna Peric
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Krakow, Polen, 31-501
- Krakowskie Centrum Medyczne sp. Z.O.O
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Nadarzyn, Polen, 05-830
- NZOZ Lecznica MAK-MED s.c.
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Poznan, Polen, 61-397
- Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
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Warszawa, Polen, 02-691
- Reumatika-Centrum Reumatologii
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Beograd
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Belgrade, Beograd, Serbia, 11000
- Institute of Rheumatology
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Bratislava, Slovakia, 841 04
- Reumatologicka ambulancia
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Dunajska Streda, Slovakia, 929 01
- AAGS, s.r.o.
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Poprad, Slovakia, 058 01
- Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.
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Rimavska Sobota, Slovakia, 979 01
- REUMEX s.r.o.
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Trnava, Slovakia, 917 01
- REUMA-GLOBAL s.r.o.
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Zilina, Slovakia, 010 01
- Reumatologicka ambulancia
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Cape Town
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Panorama, Cape Town, Sør-Afrika, 7500
- Panorama Medical Centre
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Johannesburg
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Parktown, Johannesburg, Sør-Afrika, 2193
- Wits Clinical Research CMJAH Clinical Trial Site
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Kwazulu-natal
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Durban/Berea, Kwazulu-natal, Sør-Afrika, 4001
- St. Augustines Hospital
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Berlin, Tyskland, 14059
- Schlosspark-Klinik, Innere Medizin II, Rheumatologie
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Hannover, Tyskland, 30625
- Medizinische Hochschule Hannover
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Vogelsang-Gommern, Tyskland, 39245
- Immunologisches Zentrum Vogelsang-Gommern GmbH
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Hessen
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Frankfurt/Main, Hessen, Tyskland, 60528
- Centrum für innovative Diagnostik und Therapie
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Nordrhein-westfalen
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Ratingen, Nordrhein-westfalen, Tyskland, 40882
- Rheumaforschung - Studienambulanz Dr. Wassenberg
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Budapest, Ungarn, 1036
- Qualiclinic Kft.
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Kistarcsa, Ungarn, 2143
- Pest Megyei Flor Ferenc Korhaz
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Nyiregyhaza, Ungarn, 4400
- Szabolcs-Szatmar-Bereg megyei
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: ETN 50mg QW
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50mg subcutaneous, once weekly, 24 weeks
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
Tidsramme: Week 12
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Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated.
Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
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Week 12
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Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
Tidsramme: Week 24
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Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated.
Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
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Week 24
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Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
Tidsramme: Baseline up to Week 24
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Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated.
Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
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Baseline up to Week 24
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
Tidsramme: Baseline (Day 1) up to Week 24
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Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.
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Baseline (Day 1) up to Week 24
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline (Day 1) up to Week 28 (Follow-up)
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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.
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Baseline (Day 1) up to Week 28 (Follow-up)
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Number of Participants With Investigator-Identified Serious Infections
Tidsramme: Baseline (Day 1) up to Week 28 (Follow-up)
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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.
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Baseline (Day 1) up to Week 28 (Follow-up)
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Number of Participants With Injection Site Reactions
Tidsramme: Baseline (Day 1) up to Week 28 (Follow-up)
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Injection site reactions included injection site erythema, swelling, pain and warmth.
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Baseline (Day 1) up to Week 28 (Follow-up)
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Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities
Tidsramme: Baseline (Day 1) up to Week 28 (Follow-up)
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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).
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Baseline (Day 1) up to Week 28 (Follow-up)
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Tidsramme: Week 4, 12, 24
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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.
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Week 4, 12, 24
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Tidsramme: Week 4, 12, 24
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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.
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Week 4, 12, 24
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Tidsramme: Week 4, 12, 24
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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.
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Week 4, 12, 24
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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
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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.
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Baseline, Week 4, 12, 24
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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
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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.
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Baseline, Week 4, 12, 24
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
Tidsramme: Baseline, Week 4, 12, 24
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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.
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Baseline, Week 4, 12, 24
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2015
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
13. februar 2015
Først innsendt som oppfylte QC-kriteriene
26. februar 2015
Først lagt ut (Anslag)
4. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Autoimmune sykdommer
- Leddsykdommer
- Muskel- og skjelettsykdommer
- Revmatiske sykdommer
- Bindevevssykdommer
- Leddgikt
- Leddgikt, revmatoid
- Fysiologiske effekter av legemidler
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Etanercept
Andre studie-ID-numre
- B1801359
- 2013-004569-16 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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