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

10 settembre 2014 aggiornato da: 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

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

70

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Celecoxib
Celecoxib with placebo therapy.
Droga: 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.
Altro: Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
Droga: 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.
Sperimentale: CP-195,543
CP-195,543 and Celecoxib dual therapy.
Droga: CP-195,543
CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline up to Week 12
Baseline up to Week 12
Time to Withdrawal Due to Lack of Efficacy
Lasso di tempo: Baseline up to Week 12
Baseline up to Week 12
Number of Participants With Clinical Laboratory Abnormalities
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2006

Completamento primario (Effettivo)

1 dicembre 2007

Completamento dello studio (Effettivo)

1 febbraio 2008

Date di iscrizione allo studio

Primo inviato

18 gennaio 2007

Primo inviato che soddisfa i criteri di controllo qualità

18 gennaio 2007

Primo Inserito (Stima)

19 gennaio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

25 settembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2014

Ultimo verificato

1 settembre 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A7701005

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

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Sedi

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