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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

10. september 2014 opdateret af: Pfizer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate

To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35801
        • Pfizer Investigational Site
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Pfizer Investigational Site
    • California
      • Upland, California, Forenede Stater, 91786
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Pfizer Investigational Site
      • Clearwater, Florida, Forenede Stater, 33765
        • Pfizer Investigational Site
      • Dunedin, Florida, Forenede Stater, 34698
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, Forenede Stater, 33334
        • Pfizer Investigational Site
      • Lake Mary, Florida, Forenede Stater, 32746
        • Pfizer Investigational Site
      • Miramar, Florida, Forenede Stater, 33025
        • Pfizer Investigational Site
      • New Port Richey, Florida, Forenede Stater, 34652
        • Pfizer Investigational Site
      • Orange City, Florida, Forenede Stater, 32763
        • Pfizer Investigational Site
      • Orlando, Florida, Forenede Stater, 32804
        • Pfizer Investigational Site
      • Port Richey, Florida, Forenede Stater, 34668
        • Pfizer Investigational Site
      • Sarasota, Florida, Forenede Stater, 34233
        • Pfizer Investigational Site
      • Sarasota, Florida, Forenede Stater, 34239
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33614-7118
        • Pfizer Investigational Site
      • Venice, Florida, Forenede Stater, 34292
        • Pfizer Investigational Site
      • Vero Beach, Florida, Forenede Stater, 32960
        • Pfizer Investigational Site
    • Illinois
      • Moline, Illinois, Forenede Stater, 61265
        • Pfizer Investigational Site
      • Springfield, Illinois, Forenede Stater, 62704
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250
        • Pfizer Investigational Site
      • Munster, Indiana, Forenede Stater, 46321
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40504
        • Pfizer Investigational Site
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Pfizer Investigational Site
    • Maryland
      • Frederick, Maryland, Forenede Stater, 21702
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Pfizer Investigational Site
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, Forenede Stater, 65807
        • Pfizer Investigational Site
    • New York
      • Olean, New York, Forenede Stater, 14760
        • Pfizer Investigational Site
      • Rochester, New York, Forenede Stater, 14618
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73139
        • Pfizer Investigational Site
    • Pennsylvania
      • Philladelphia, Pennsylvania, Forenede Stater, 19118
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37909-1600
        • Pfizer Investigational Site
      • Memphis, Tennessee, Forenede Stater, 38119
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Forenede Stater, 77090
        • Pfizer Investigational Site
      • Killeen, Texas, Forenede Stater, 76549
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78217
        • Pfizer Investigational Site
    • Utah
      • Ogden, Utah, Forenede Stater, 84403
        • Pfizer Investigational Site

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria
  • Active disease at Screening
  • Stable dose of methotrexate between 10-25 mg/week oral or parenteral

Exclusion Criteria:

  • A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments
  • A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides

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: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Celecoxib
Celecoxib with placebo therapy.
Medicin: celecoxib
Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.
Andet: Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
Medicin: Methotrexate
Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.
Eksperimentel: CP-195,543
CP-195,543 and Celecoxib dual therapy.
Medicin: CP-195,543
CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Tidsramme: Week 12
ACR20 response: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8
Tidsramme: Week 1, 2, 4, 8
ACR20 response: >=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 1, 2, 4, 8
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Tidsramme: Week 1, 2, 4, 8, 12
ACR50 response: >=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 1, 2, 4, 8, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Tidsramme: Week 1, 2, 4, 8, 12
ACR70 response: >=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 1, 2, 4, 8, 12
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 2, 4, 8, 12
Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 2, 4, 8, 12
Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 2, 4, 8, 12
Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 2, 4, 8, 12
Patient's global assessment of arthritic condition assessed all the ways participants' illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 2, 4, 8, 12
Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 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 1, 2, 4, 8, 12
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 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 1, 2, 4, 8, 12
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 2, 4, 8, 12
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 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 1, 2, 4, 8, 12
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12
Tidsramme: Baseline, Week 1, 2, 4, 8, 12
Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).
Baseline, Week 1, 2, 4, 8, 12
Number of Participants Who Withdrew From Study Due to Lack of Efficacy
Tidsramme: Baseline up to Week 12
Baseline up to Week 12
Time to Withdrawal Due to Lack of Efficacy
Tidsramme: Baseline up to Week 12
Baseline up to Week 12
Number of Participants With Clinical Laboratory Abnormalities
Tidsramme: Baseline up to Week 13
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
Baseline up to Week 13

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to 28 days after last dose
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to 28 days after last dose
Number of Adverse Events by Severity
Tidsramme: Baseline up to 28 days after last dose
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Baseline up to 28 days after last dose
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91
Tidsramme: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.
Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91
Tidsramme: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Number of Participants With Abnormal Electrocardiogram (ECG)
Tidsramme: Baseline up to Week 12
Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
Baseline up to Week 12
Number of Participants With Categorical Vital Signs Data
Tidsramme: Baseline, Week 12
Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.
Baseline, Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 2006

Primær færdiggørelse (Faktiske)

1. december 2007

Studieafslutning (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

18. januar 2007

Først indsendt, der opfyldte QC-kriterier

18. januar 2007

Først opslået (Skøn)

19. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A7701005

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 .

Kliniske forsøg med Gigt, reumatoid

Kliniske forsøg med celecoxib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner