Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

24 agosto 2016 aggiornato da: Janssen Research & Development, LLC

A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

65

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
  • Aged between 18 and 75 years (both inclusive)
  • Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
  • Use of highly effective contraception during the trial (both males and females)

Exclusion Criteria:

  • A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
  • An active or latent tuberculosis
  • Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
  • A known significant cardio-vascular disease
  • Vaccination against live virus or bacteria within 4 weeks prior to randomization
  • The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
  • A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
  • Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SD 0.0002 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD 0.0012 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD 0.007 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD 0.035 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD 0.175 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD 0.7 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD 2.5 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD 7.5 mg/kg
Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: SD Placebo
Subjects were injected once with placebo
Droga: placebo
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times
Sperimentale: MD 0.02 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: MD 0.3 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: MD 1.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: MD 1.6 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: MD 4.0 mg/kg
Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
Droga: NNC0142-0002
Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1
Droga: NNC0142-0002
Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly
Sperimentale: MD Placebo
Subjects were injected biweekly four times with placebo
Droga: placebo
Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frequency of Adverse Events
Lasso di tempo: Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.
Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.
Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area Under the Concentration-time Curve (AUC)
Lasso di tempo: Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.
Systemic exposure to NNC0142-0002.
Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Britta Væver Bysted, DVM, PhD, Novo Nordisk A/S

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2009

Completamento primario (Effettivo)

1 dicembre 2011

Completamento dello studio (Effettivo)

1 dicembre 2011

Date di iscrizione allo studio

Primo inviato

24 giugno 2009

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2009

Primo Inserito (Stima)

25 giugno 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

3 ottobre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 agosto 2016

Ultimo verificato

1 agosto 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NN8555-3618
  • 2008-008703-18 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su NNC0142-0002

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Tanzania

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi