Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

10. September 2014 aktualisiert von: 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

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

70

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Celecoxib
Celecoxib with placebo therapy.
Arzneimittel: 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.
Sonstiges: Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
Arzneimittel: 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.
Experimental: CP-195,543
CP-195,543 and Celecoxib dual therapy.
Arzneimittel: CP-195,543
CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2006

Primärer Abschluss (Tatsächlich)

1. Dezember 2007

Studienabschluss (Tatsächlich)

1. Februar 2008

Studienanmeldedaten

Zuerst eingereicht

18. Januar 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Januar 2007

Zuerst gepostet (Schätzen)

19. Januar 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

25. September 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. September 2014

Zuletzt verifiziert

1. September 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A7701005

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Arthritis, Rheuma

Klinische Studien zur celecoxib

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Azerbaijan

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren