A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
10 сентября 2014 г. обновлено: 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
Обзор исследования
Статус
Прекращено
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
70
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Alabama
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Huntsville, Alabama, Соединенные Штаты, 35801
- Pfizer Investigational Site
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Arizona
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Scottsdale, Arizona, Соединенные Штаты, 85251
- Pfizer Investigational Site
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California
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Upland, California, Соединенные Штаты, 91786
- Pfizer Investigational Site
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Florida
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Boca Raton, Florida, Соединенные Штаты, 33486
- Pfizer Investigational Site
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Clearwater, Florida, Соединенные Штаты, 33765
- Pfizer Investigational Site
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Dunedin, Florida, Соединенные Штаты, 34698
- Pfizer Investigational Site
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Fort Lauderdale, Florida, Соединенные Штаты, 33334
- Pfizer Investigational Site
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Lake Mary, Florida, Соединенные Штаты, 32746
- Pfizer Investigational Site
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Miramar, Florida, Соединенные Штаты, 33025
- Pfizer Investigational Site
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New Port Richey, Florida, Соединенные Штаты, 34652
- Pfizer Investigational Site
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Orange City, Florida, Соединенные Штаты, 32763
- Pfizer Investigational Site
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Orlando, Florida, Соединенные Штаты, 32804
- Pfizer Investigational Site
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Port Richey, Florida, Соединенные Штаты, 34668
- Pfizer Investigational Site
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Sarasota, Florida, Соединенные Штаты, 34233
- Pfizer Investigational Site
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Sarasota, Florida, Соединенные Штаты, 34239
- Pfizer Investigational Site
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Tampa, Florida, Соединенные Штаты, 33614-7118
- Pfizer Investigational Site
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Venice, Florida, Соединенные Штаты, 34292
- Pfizer Investigational Site
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Vero Beach, Florida, Соединенные Штаты, 32960
- Pfizer Investigational Site
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Illinois
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Moline, Illinois, Соединенные Штаты, 61265
- Pfizer Investigational Site
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Springfield, Illinois, Соединенные Штаты, 62704
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46250
- Pfizer Investigational Site
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Munster, Indiana, Соединенные Штаты, 46321
- Pfizer Investigational Site
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Kentucky
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Lexington, Kentucky, Соединенные Штаты, 40504
- Pfizer Investigational Site
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Louisiana
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Covington, Louisiana, Соединенные Штаты, 70433
- Pfizer Investigational Site
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New Orleans, Louisiana, Соединенные Штаты, 70115
- Pfizer Investigational Site
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Maryland
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Frederick, Maryland, Соединенные Штаты, 21702
- Pfizer Investigational Site
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Michigan
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Kalamazoo, Michigan, Соединенные Штаты, 49009
- Pfizer Investigational Site
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Mississippi
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Tupelo, Mississippi, Соединенные Штаты, 38801
- Pfizer Investigational Site
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Missouri
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Springfield, Missouri, Соединенные Штаты, 65807
- Pfizer Investigational Site
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New York
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Olean, New York, Соединенные Штаты, 14760
- Pfizer Investigational Site
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Rochester, New York, Соединенные Штаты, 14618
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73139
- Pfizer Investigational Site
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Pennsylvania
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Philladelphia, Pennsylvania, Соединенные Штаты, 19118
- Pfizer Investigational Site
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Tennessee
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Knoxville, Tennessee, Соединенные Штаты, 37909-1600
- Pfizer Investigational Site
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Memphis, Tennessee, Соединенные Штаты, 38119
- Pfizer Investigational Site
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Texas
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Houston, Texas, Соединенные Штаты, 77090
- Pfizer Investigational Site
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Killeen, Texas, Соединенные Штаты, 76549
- Pfizer Investigational Site
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San Antonio, Texas, Соединенные Штаты, 78217
- Pfizer Investigational Site
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Utah
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Ogden, Utah, Соединенные Штаты, 84403
- Pfizer Investigational Site
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Celecoxib
Celecoxib with placebo therapy.
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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.
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Другой: Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
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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.
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Экспериментальный: CP-195,543
CP-195,543 and Celecoxib dual therapy.
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CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Временное ограничение: Week 12
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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).
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Week 12
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8
Временное ограничение: Week 1, 2, 4, 8
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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).
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Week 1, 2, 4, 8
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Временное ограничение: Week 1, 2, 4, 8, 12
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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).
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Week 1, 2, 4, 8, 12
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Временное ограничение: Week 1, 2, 4, 8, 12
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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).
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Week 1, 2, 4, 8, 12
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Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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.
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Baseline, Week 1, 2, 4, 8, 12
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Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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.
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Baseline, Week 1, 2, 4, 8, 12
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Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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.
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Baseline, Week 1, 2, 4, 8, 12
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Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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).
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Baseline, Week 1, 2, 4, 8, 12
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Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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).
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Baseline, Week 1, 2, 4, 8, 12
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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.
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Baseline, Week 1, 2, 4, 8, 12
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Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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.
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Baseline, Week 1, 2, 4, 8, 12
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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
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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.
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Baseline, Week 1, 2, 4, 8, 12
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Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12
Временное ограничение: Baseline, Week 1, 2, 4, 8, 12
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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).
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Baseline, Week 1, 2, 4, 8, 12
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Number of Participants Who Withdrew From Study Due to Lack of Efficacy
Временное ограничение: Baseline up to Week 12
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Baseline up to Week 12
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Time to Withdrawal Due to Lack of Efficacy
Временное ограничение: Baseline up to Week 12
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Baseline up to Week 12
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Number of Participants With Clinical Laboratory Abnormalities
Временное ограничение: Baseline up to Week 13
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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]).
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Baseline up to Week 13
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Временное ограничение: Baseline up to 28 days after last dose
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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.
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Baseline up to 28 days after last dose
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Number of Adverse Events by Severity
Временное ограничение: Baseline up to 28 days after last dose
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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.
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Baseline up to 28 days after last dose
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Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91
Временное ограничение: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
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Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.
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Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
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Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91
Временное ограничение: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
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Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
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Number of Participants With Abnormal Electrocardiogram (ECG)
Временное ограничение: Baseline up to Week 12
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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.
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Baseline up to Week 12
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Number of Participants With Categorical Vital Signs Data
Временное ограничение: Baseline, Week 12
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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
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июня 2006 г.
Первичное завершение (Действительный)
1 декабря 2007 г.
Завершение исследования (Действительный)
1 февраля 2008 г.
Даты регистрации исследования
Первый отправленный
18 января 2007 г.
Впервые представлено, что соответствует критериям контроля качества
18 января 2007 г.
Первый опубликованный (Оценивать)
19 января 2007 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
25 сентября 2014 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 сентября 2014 г.
Последняя проверка
1 сентября 2014 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания иммунной системы
- Аутоиммунные заболевания
- Заболевания суставов
- Заболевания опорно-двигательного аппарата
- Ревматические заболевания
- Заболевания соединительной ткани
- Артрит
- Артрит, Ревматоидный
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Агенты периферической нервной системы
- Ингибиторы синтеза нуклеиновых кислот
- Ингибиторы ферментов
- Анальгетики
- Агенты сенсорной системы
- Противовоспалительные средства, нестероидные
- Анальгетики, ненаркотические
- Противовоспалительные агенты
- Противоревматические агенты
- Ингибиторы циклооксигеназы
- Антиметаболиты, Противоопухолевые
- Антиметаболиты
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Дерматологические агенты
- Агенты репродуктивного контроля
- Ингибиторы циклооксигеназы 2
- Абортивные агенты, нестероидные
- Абортивные агенты
- Антагонисты фолиевой кислоты
- Целекоксиб
- Метотрексат
Другие идентификационные номера исследования
- A7701005
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .