Assess Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
17. november 2016 opdateret af: MedImmune LLC
A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects With Rheumatoid Arthritis
This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
29
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Anniston, Alabama, Forenede Stater, 36207
- Pinnacle Research Group, LLC
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Florida
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Orlando, Florida, Forenede Stater, 32804
- Omega Research Consultants, LLC.
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Palm Harbor, Florida, Forenede Stater, 34684
- Arthritis Center, Inc.
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Maryland
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Frederick, Maryland, Forenede Stater, 21702
- Arthritis Treatment Center
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68516
- Physician Research Collaboration, LLC
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Pennsylvania
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Duncansville, Pennsylvania, Forenede Stater, 16635
- Altoona Center for Clinical Research
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Texas
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Dallas, Texas, Forenede Stater, 75231
- Metroplex Clinical Research Center
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-
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 til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Must be able to provide written informed consent
- Body mass index 18.5 to 35.0 kg/m2
- Diagnosis of Rheumatoid Arthritis according to 1987 revised American College of Rheumatology (ACR) criteria
- Global Functional Class I, II, or III according to ACR 1991 revised criteria
- Must have at least 4 tender joints and 4 swollen joints (28-joint assesssment)
- Use of >/= 1 non-steroidal anti-inflammatory drugs is allowed, subject must be on a stable dose for >/= 2 weeks prior to randomization
- Use of >/= 1 Disease Modifying Anti-rheumatic Drugs (DMARD) for >/= 3 months and a stable dose for >/= 6 weeks prior to randomization
- Stable use of low dose oral corticosteroids (</= 10 mg prednisone per day or equivalent) is allowed; subjects must be on a stable dose for >/= 4 weeks prior to randomization
Exclusion Criteria:
Prior to Day 0, use of:
- Rituximab within 6 months
- Abatacept within 3 months
- Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, Azathioprine or Mycophenolate mofetil within 2 months
- Etanercept, Anakinra, immunoglobulin or blood products within 28 days
- Prior immunotherapy, including high dose oral corticosteroids or systemic corticosteroids such as prednisone, biologics, Janus kinase (JAK) inhibitors, such as tofacitinib or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer
- Prior exposure to T cell depleting agents such as Campath (alemtuzumab)
- Evidence of any active or recent infection
- History of systemic autoimmune disease other than Rheumatoid Arthritis; secondary Sjogren's syndrome, rheumatoid vasculitis and orther extra-articular manifestations of RA allowed
- History of allergic reactions
- History of anaphylaxis or allergic diathesis
- Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
- Evidence of active or latent tuberculosis
- Vaccination with live attenuated viruses within the 2 weeks prior to Day 0
- Pregnant or breastfeeding women
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: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Crossover Group 1
Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo
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2, 5, or 10 mg/kg
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Eksperimentel: Crossover Group 2
Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week
|
Placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptable number of adverse events per subject as a measure of safety and tolerability of repeat doses of AMP-110 versus placebo
Tidsramme: From start of study drug administration through Day 112
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Determined by the number of AEs, SAEs, and results in laboratory evaluations, vital signs, electrocardiograms and physical examinations
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From start of study drug administration through Day 112
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Repeat dose pharmacokinetic parameters of AMP-110 in serum
Tidsramme: From start of study drug administration through Day 112
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Parameters will include maximum observed concentration (Cmax), area under the concentration-time curve (AUC), total body clearance and terminal half-life
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From start of study drug administration through Day 112
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Optimal dose for repeat dosing of AMP-110
Tidsramme: From start of study drug administration through Day 112
|
Optimal dose will be determined through the occurrence of AEs, SAEs, ACR-20 and DAS-28 results, and individual AMP-110 concentrations in serum including peak and trough levels
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From start of study drug administration through Day 112
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical responses via RA disease scoring systems
Tidsramme: From start of study drug administration through Day 112
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Explore the pharmacodynamics (PD) of repeat doses of AMP-110 versus placebo in subjects with RA
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From start of study drug administration through Day 112
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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. juni 2014
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først indsendt
23. juli 2014
Først indsendt, der opfyldte QC-kriterier
27. oktober 2014
Først opslået (Skøn)
29. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AMP-110-02
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 .