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

10 september 2014 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

70

Fas

  • Fas 2

Kontakter och platser

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

Studieorter

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

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 och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

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: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Celecoxib
Celecoxib with placebo therapy.
Läkemedel: 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.
Övrig: Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
Läkemedel: 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.
Experimentell: CP-195,543
CP-195,543 and Celecoxib dual therapy.
Läkemedel: CP-195,543
CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline up to Week 12
Baseline up to Week 12
Time to Withdrawal Due to Lack of Efficacy
Tidsram: Baseline up to Week 12
Baseline up to Week 12
Number of Participants With Clinical Laboratory Abnormalities
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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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.

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

1 juni 2006

Primärt slutförande (Faktisk)

1 december 2007

Avslutad studie (Faktisk)

1 februari 2008

Studieregistreringsdatum

Först inskickad

18 januari 2007

Först inskickad som uppfyllde QC-kriterierna

18 januari 2007

Första postat (Uppskatta)

19 januari 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 september 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2014

Senast verifierad

1 september 2014

Mer information

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Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A7701005

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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