- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00838565
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
12. mars 2018 oppdatert av: Pfizer
Phase 1, Randomized, Patient And Investigator-blind, Placebo-controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of Pf-04236921 In Patients With Rheumatoid Arthritis Receiving Methotrexate
This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions.
Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels.
Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.
Studietype
Intervensjonell
Registrering (Faktiske)
41
Fase
- Fase 1
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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Florida
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Daytona Beach, Florida, Forente stater, 32114
- Allergy, Asthma, Arthritis, & Lung
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Ormond Beach, Florida, Forente stater, 32174
- Millennium Research
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Pennsylvania
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Duncansville, Pennsylvania, Forente stater, 16635
- Altoona Center for Clinical Research
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Incheon, Korea, Republikken, 400-711
- Inha University Hospital, Medicine/Rheumatology
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Seoul, Korea, Republikken, 110-744
- Seoul National University Hospital, Rheumatology, Internal Medicine
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Seoul, Korea, Republikken, 120-752
- Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center
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A Coruña, Spania, 15006
- Complexo Hospitalario Universitario A Coruña
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A Coruña
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Santiago de Compostela, A Coruña, Spania, 15706
- Hospital Clínico Universitario de Santiago
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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 til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Rheumatoid Arthritis on a stable dose of methotrexate
- Rheumatoid Arthritis disease activity as assessed by blood tests
Exclusion Criteria:
- Serious or uncontrolled medical conditions
- Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
- Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
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intravenous infusion on three consecutive months
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Eksperimentell: PF-04236921
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intravenous infusion on three consecutive months
intravenous infusion on three consecutive months
intravenous infusion on three consecutive months
intravenous infusion on 3 consecutive months
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
|
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship.
An 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 are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ 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 up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
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Number of Participants With Positive Anti-drug Antibodies Response
Tidsramme: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
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Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
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Maximum Observed Serum Concentration (Cmax): Day 1
Tidsramme: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1
Tidsramme: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1
Tidsramme: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
|
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
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Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
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Maximum Observed Serum Concentration (Cmax): Day 28
Tidsramme: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
Tidsramme: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28
Tidsramme: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
|
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
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Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
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Maximum Observed Serum Concentration (Cmax): Day 56
Tidsramme: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
Tidsramme: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56
Tidsramme: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
|
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
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Serum Decay Half-Life (t1/2): Day 56
Tidsramme: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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Serum decay half-life is the time measured for the serum concentration to decrease by one half.
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Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation
Tidsramme: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra sensitive assay.
A decrease in the level of CRP indicates reduction in inflammation.
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Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
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Change From Baseline in Log CRP Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
Tidsramme: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
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Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation
Tidsramme: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
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Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
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Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624
Tidsramme: Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
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Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method.
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Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
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Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
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 (Faktiske)
20. mai 2009
Primær fullføring (Faktiske)
2. februar 2012
Studiet fullført (Faktiske)
2. februar 2012
Datoer for studieregistrering
Først innsendt
4. februar 2009
Først innsendt som oppfylte QC-kriteriene
4. februar 2009
Først lagt ut (Anslag)
6. februar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B0151002
- 2009-009866-15 (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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