A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
keskiviikko 10. syyskuuta 2014 päivittänyt: 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
Tutkimuksen yleiskatsaus
Tila
Lopetettu
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
70
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Alabama
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Huntsville, Alabama, Yhdysvallat, 35801
- Pfizer Investigational Site
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Arizona
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Scottsdale, Arizona, Yhdysvallat, 85251
- Pfizer Investigational Site
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California
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Upland, California, Yhdysvallat, 91786
- Pfizer Investigational Site
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Florida
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Boca Raton, Florida, Yhdysvallat, 33486
- Pfizer Investigational Site
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Clearwater, Florida, Yhdysvallat, 33765
- Pfizer Investigational Site
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Dunedin, Florida, Yhdysvallat, 34698
- Pfizer Investigational Site
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Fort Lauderdale, Florida, Yhdysvallat, 33334
- Pfizer Investigational Site
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Lake Mary, Florida, Yhdysvallat, 32746
- Pfizer Investigational Site
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Miramar, Florida, Yhdysvallat, 33025
- Pfizer Investigational Site
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New Port Richey, Florida, Yhdysvallat, 34652
- Pfizer Investigational Site
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Orange City, Florida, Yhdysvallat, 32763
- Pfizer Investigational Site
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Orlando, Florida, Yhdysvallat, 32804
- Pfizer Investigational Site
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Port Richey, Florida, Yhdysvallat, 34668
- Pfizer Investigational Site
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Sarasota, Florida, Yhdysvallat, 34233
- Pfizer Investigational Site
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Sarasota, Florida, Yhdysvallat, 34239
- Pfizer Investigational Site
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Tampa, Florida, Yhdysvallat, 33614-7118
- Pfizer Investigational Site
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Venice, Florida, Yhdysvallat, 34292
- Pfizer Investigational Site
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Vero Beach, Florida, Yhdysvallat, 32960
- Pfizer Investigational Site
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Illinois
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Moline, Illinois, Yhdysvallat, 61265
- Pfizer Investigational Site
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Springfield, Illinois, Yhdysvallat, 62704
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, Yhdysvallat, 46250
- Pfizer Investigational Site
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Munster, Indiana, Yhdysvallat, 46321
- Pfizer Investigational Site
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Kentucky
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Lexington, Kentucky, Yhdysvallat, 40504
- Pfizer Investigational Site
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Louisiana
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Covington, Louisiana, Yhdysvallat, 70433
- Pfizer Investigational Site
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New Orleans, Louisiana, Yhdysvallat, 70115
- Pfizer Investigational Site
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Maryland
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Frederick, Maryland, Yhdysvallat, 21702
- Pfizer Investigational Site
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Michigan
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Kalamazoo, Michigan, Yhdysvallat, 49009
- Pfizer Investigational Site
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Mississippi
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Tupelo, Mississippi, Yhdysvallat, 38801
- Pfizer Investigational Site
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Missouri
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Springfield, Missouri, Yhdysvallat, 65807
- Pfizer Investigational Site
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New York
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Olean, New York, Yhdysvallat, 14760
- Pfizer Investigational Site
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Rochester, New York, Yhdysvallat, 14618
- Pfizer Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73139
- Pfizer Investigational Site
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Pennsylvania
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Philladelphia, Pennsylvania, Yhdysvallat, 19118
- Pfizer Investigational Site
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Tennessee
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Knoxville, Tennessee, Yhdysvallat, 37909-1600
- Pfizer Investigational Site
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Memphis, Tennessee, Yhdysvallat, 38119
- Pfizer Investigational Site
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Texas
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Houston, Texas, Yhdysvallat, 77090
- Pfizer Investigational Site
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Killeen, Texas, Yhdysvallat, 76549
- Pfizer Investigational Site
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San Antonio, Texas, Yhdysvallat, 78217
- Pfizer Investigational Site
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Utah
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Ogden, Utah, Yhdysvallat, 84403
- Pfizer Investigational Site
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Active Comparator: 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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Muut: 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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Kokeellinen: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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.
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Baseline, Week 12
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Torstai 1. kesäkuuta 2006
Ensisijainen valmistuminen (Todellinen)
Lauantai 1. joulukuuta 2007
Opintojen valmistuminen (Todellinen)
Perjantai 1. helmikuuta 2008
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 18. tammikuuta 2007
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 18. tammikuuta 2007
Ensimmäinen Lähetetty (Arvio)
Perjantai 19. tammikuuta 2007
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 25. syyskuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 10. syyskuuta 2014
Viimeksi vahvistettu
Maanantai 1. syyskuuta 2014
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Immuunijärjestelmän sairaudet
- Autoimmuunisairaudet
- Nivelsairaudet
- Tuki- ja liikuntaelinten sairaudet
- Reumaattiset sairaudet
- Sidekudostaudit
- Niveltulehdus
- Niveltulehdus, nivelreuma
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Ääreishermoston aineet
- Nukleiinihapposynteesin estäjät
- Entsyymin estäjät
- Analgeetit
- Aistijärjestelmän agentit
- Tulehduskipuaineet, ei-steroidiset
- Analgeetit, ei-huumeet
- Tulehdusta ehkäisevät aineet
- Reumaattiset aineet
- Syklo-oksigenaasin estäjät
- Antimetaboliitit, antineoplastiset
- Antimetaboliitit
- Antineoplastiset aineet
- Immunosuppressiiviset aineet
- Immunologiset tekijät
- Dermatologiset aineet
- Lisääntymistä säätelevät aineet
- Syklo-oksigenaasi 2:n estäjät
- Raskaudenkeskeytysaineet, ei-steroidiset
- Abortiagentit
- Foolihappoantagonistit
- Selekoksibi
- Metotreksaatti
Muut tutkimustunnusnumerot
- A7701005
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Niveltulehdus, nivelreuma
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RemeGen Co., Ltd.ValmisKeskivaikea ja vaikea RheumatoId-niveltulehdusKiina