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Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate

9 mars 2022 uppdaterad av: Pfizer

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7 RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELY CONTROLLED ON METHOTREXATE

CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Chile
    • Santiago, RM
      • Providencia, Santiago, RM, Chile, 7530206
        • Clínica Santa María, Sección Reumatología
  • Förenta staterna
    • Arizona
      • Mesa, Arizona, Förenta staterna, 85202
        • Arizona Arthritis & Rheumatology Associates, P.C.
    • Florida
      • DeBary, Florida, Förenta staterna, 32713
        • Omega Research Consultants LLC
      • Lake Mary, Florida, Förenta staterna, 32746
        • Florida Arthritis Center
      • Tampa, Florida, Förenta staterna, 33614
        • Tampa Medical Group, Pa
    • Indiana
      • Avon, Indiana, Förenta staterna, 46123
        • American Health Network
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70115
        • George Stanley Walker, MD
      • New Orleans, Louisiana, Förenta staterna, 70115
        • Best Clinical Trials, LLC (Administrative Only)
      • New Orleans, Louisiana, Förenta staterna, 70115
        • Majid Abdul Jawad, MD
    • Maryland
      • Frederick, Maryland, Förenta staterna, 21702
        • The Arthritis and Osteoporosis Center of Maryland
    • Missouri
      • Columbia, Missouri, Förenta staterna, 65212
        • University of Missouri-Columbia
      • Columbia, Missouri, Förenta staterna, 65203
        • University Physicians
    • Nevada
      • Reno, Nevada, Förenta staterna, 89502
        • Arthritis Center of Reno
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45242
        • New Horizons Clinical Research
    • Washington
      • Spokane, Washington, Förenta staterna, 99204-2336
        • Arthritis Northwest
  • Korea, Republiken av
      • Incheon, Korea, Republiken av, 400-711
        • Inha University Hospital, Medicine/Rheumatology
      • Pusan, Korea, Republiken av, 602-739
        • Pusan National University Hospital, Rheumatology, Internal Medicine
  • Mexiko
    • D.f.
      • Mexico, D.f., Mexiko, 03300
        • Investigadores Clinicos Asociados
  • Polen
      • Krakow, Polen, 31-501
        • Krakowskie Centrum Medyczne NZOZ
      • Poznan, Polen, 60-356
        • Zaklad Reumatologii i Immunologii Klinicznej
      • Poznan, Polen, 61-545
        • Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny
  • Spanien
      • A Coruña, Spanien, 15006
        • Complexo Hospitalario Universitario A Coruña
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Maranon
    • A Coruña
      • Santiago de Compostela, A Coruña, Spanien, 15705
        • Hospital Nuestra Señora de La Esperanza
  • Tjeckien
      • Ceska Lipa, Tjeckien, 470 01
        • Revmatologicka ambulance
      • Praha 2, Tjeckien, 128 50
        • Revmatologicky ustav
      • Praha 4, Tjeckien, 140 00
        • Revmatologicka ambulance

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Active rheumatoid arthritis
  • Incomplete response to methotrexate

Exclusion Criteria:

  • Must not be on biologic therapies
  • No recent infections

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Läkemedel: Placebo
ingen aktiv ingrediens
Experimentell: Aktiva
Läkemedel: CE-224,535
500 mg po BID

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
Tidsram: Week 12
ACR20 response: compared to baseline, greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
Tidsram: Week 2, 4, 8
ACR20 response: compared to baseline, >=20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 2, 4, 8
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Tidsram: Week 2, 4, 8, 12
ACR50 response: compared to baseline, >=50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 2, 4, 8, 12
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Tidsram: Week 2, 4, 8, 12
ACR70 response: compared to baseline, >=70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 2, 4, 8, 12
Number of Tender/Painful and Swollen Joints
Tidsram: Baseline, Week 2, 4, 8, 12
Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Baseline, Week 2, 4, 8, 12
Physician Global Assessment (PGA) of Arthritis
Tidsram: Baseline, Week 2, 4, 8, 12
Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor. This was an evaluation based on the participant's disease signs, functional capacity and physical examination.
Baseline, Week 2, 4, 8, 12
Patient's Global Assessment of Arthritis
Tidsram: Baseline, Week 2, 4, 8, 12
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly.
Baseline, Week 2, 4, 8, 12
Patient's Global Assessment of Arthritic Pain
Tidsram: Baseline, Week 2, 4, 8, 12
Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain.
Baseline, Week 2, 4, 8, 12
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Tidsram: Baseline, Week 2, 4, 8, 12
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. 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 0-3 where 0= least difficulty and 3= extreme difficulty.
Baseline, Week 2, 4, 8, 12
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Tidsram: Baseline, Week 2, 4, 8, 12
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Baseline, Week 2, 4, 8, 12
C-Reactive Protein (CRP)
Tidsram: Baseline, Week 2, 4, 8, 12
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.
Baseline, Week 2, 4, 8, 12
Incidence of Withdrawal Due to Lack of Efficacy
Tidsram: Week 2, 4, 8, 12, 14
Number of participants who withrew due to lack of efficacy were reported.
Week 2, 4, 8, 12, 14
Time to Withdrawal Due to Lack of Efficacy
Tidsram: Baseline up to Week 14
Baseline up to Week 14

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CE-224,535 Plasma Concentrations
Tidsram: 0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4
Nominal times were used for summarizing the pharmacokinetic results (0 hours at randomization [Day 1] and Week 4 [pre-dose]; 1 hour at Week 2 [post-dose]; 2 hours at randomization [post-dose on Day 1]; and 3 hours at Week 2 [post-dose] and Week 4 [post-dose]).
0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 april 2008

Primärt slutförande (Faktisk)

4 februari 2009

Avslutad studie (Faktisk)

4 februari 2009

Studieregistreringsdatum

Först inskickad

25 februari 2008

Först inskickad som uppfyllde QC-kriterierna

25 februari 2008

Första postat (Uppskatta)

4 mars 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 mars 2022

Senast verifierad

1 mars 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A6341009
  • 2008-000327-25 (EudraCT-nummer)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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