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Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

14. října 2015 aktualizováno: Novartis Pharmaceuticals

Randomized, Double-blind Placebo-controlled Multi-center Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Psoriatic Arthritis

This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

42

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Holandsko
    • DE
      • Amsterdamn, DE, Holandsko, 1100
        • Novartis Investigative Site
    • KR
      • Meerssen, KR, Holandsko, 6231
        • Novartis Investigative Site
  • Německo
      • Berlin, Německo, 12203
        • Novartis Investigative Site
      • Hamburg, Německo, 22081
        • Novartis Investigative Site
      • Hamburg, Německo, 22415
        • Novartis Investigative Site
      • Herne, Německo, 44649
        • Novartis Investigative Site
      • Muenchen, Německo, 80336
        • Novartis Investigative Site
  • Spojené království
      • Glasgow, Spojené království, G12 8TA
        • Novartis Investigative Site
      • Leeds, Spojené království, LS7 4SA
        • Novartis Investigative Site
      • Newcastle upon Tyne, Spojené království, NE2 4HH
        • Novartis Investigative Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • A diagnosis of psoriatic arthritis

Exclusion Criteria:

  • Patients with arthritis or ankylosing spondyitis
  • Drug-induced psoriasis
  • Male or female patients who plan to conceive during the time course of the study, or for 6 months after the administration of the second dose.
  • Participation in any clinical trial within 4 weeks prior to initial dosing or longer.
  • Previous use of immunosuppressive agents eg cyclosporine, without the necessary wash-out period
  • History of severe allergy to food or drugs
  • Positive TB test. Other protocol-defined inclusion/exclusion criteria may apply

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: AIN457 (2x 10mg/kg)
Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
Biologický: AIN457
The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.
Komparátor placeba: Placebo
Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
Biologický: Placebo
Matching placebo to AIN457

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of ACR Responders Per Treatment at Week 6
Časové okno: week 6
A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)
week 6
Percentage of PsARC Responders Per Treatment at Week 6
Časové okno: week 6

Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity

A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)
week 6

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria
Časové okno: Day 8 and 15, Weeks 6, 8, 12, 16 and 24
A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)
Day 8 and 15, Weeks 6, 8, 12, 16 and 24
Percentage of Participants Who Achieved PsARC Response
Časové okno: Day 8 and 15, Weeks 6, 8, 12, 16 and 24
responder" defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)
Day 8 and 15, Weeks 6, 8, 12, 16 and 24
Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment
Časové okno: Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24
The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).
Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24
Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment
Časové okno: Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24
The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease).
Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24
SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment
Časové okno: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease.
Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment
Časové okno: Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers.
Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24
Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment
Časové okno: Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24
The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.
Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24
Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Časové okno: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration
Časové okno: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)
Časové okno: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
Časové okno: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)
Časové okno: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)
Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
Časové okno: Day 1 till end of the study (169)
On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.
Day 1 till end of the study (169)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2009

Primární dokončení (Aktuální)

1. prosince 2010

Dokončení studie (Aktuální)

1. prosince 2010

Termíny zápisu do studia

První předloženo

16. prosince 2008

První předloženo, které splnilo kritéria kontroly kvality

16. prosince 2008

První zveřejněno (Odhad)

17. prosince 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

13. listopadu 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. října 2015

Naposledy ověřeno

1. října 2015

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CAIN457A2206

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