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A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

6. desember 2012 oppdatert av: Pfizer

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

795

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Campsie, New South Wales, Australia, 2194
        • Pfizer Investigational Site
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Pfizer Investigational Site
      • Maroochydore, Queensland, Australia, 4558
        • Pfizer Investigational Site
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Pfizer Investigational Site
    • Victoria
      • Malvern East, Victoria, Australia, 3145
        • Pfizer Investigational Site
    • Western Australia
      • Shenton Park, Western Australia, Australia, 6008
        • Pfizer Investigational Site
  • Chile
      • Vina del Mar, Chile, 2570017
        • Pfizer Investigational Site
    • RM
      • Santiago, RM, Chile, 7510186
        • Pfizer Investigational Site
      • Santiago, RM, Chile, 8360156
        • Pfizer Investigational Site
    • Santiago, RM
      • Providencia, Santiago, RM, Chile, 7530206
        • Pfizer Investigational Site
    • V Region
      • Vina del Mar, V Region, Chile, 2570017
        • Pfizer Investigational Site
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
    • Santander
      • Bucaramanga, Santander, Colombia
        • Pfizer Investigational Site
  • Danmark
      • Frederiksberg, Danmark, 2000
        • Pfizer Investigational Site
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen, 115093
        • Pfizer Investigational Site
      • Moscow, Den russiske føderasjonen, 115446
        • Pfizer Investigational Site
      • Petrozavodsk, Den russiske føderasjonen, 185019
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, 00120
        • Pfizer Investigational Site
      • Hyvinkaa, Finland, 05800
        • Pfizer Investigational Site
      • Tampere, Finland, 33520
        • Pfizer Investigational Site
  • Forente stater
    • Alabama
      • Huntsville, Alabama, Forente stater, 35801
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • Pfizer Investigational Site
    • California
      • Palo Alto, California, Forente stater, 94304
        • Pfizer Investigational Site
      • Stanford, California, Forente stater, 94305
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, Forente stater, 80304
        • Pfizer Investigational Site
      • Denver, Colorado, Forente stater, 80206
        • Pfizer Investigational Site
    • Connecticut
      • Danbury, Connecticut, Forente stater, 06810
        • Pfizer Investigational Site
      • Hamden, Connecticut, Forente stater, 06518
        • Pfizer Investigational Site
      • Trumbull, Connecticut, Forente stater, 06611
        • Pfizer Investigational Site
    • Florida
      • New Port Richey, Florida, Forente stater, 34652
        • Pfizer Investigational Site
      • Ocala, Florida, Forente stater, 34474
        • Pfizer Investigational Site
      • Plantation, Florida, Forente stater, 33324
        • Pfizer Investigational Site
      • Port Richey, Florida, Forente stater, 34668
        • Pfizer Investigational Site
      • Tamarac, Florida, Forente stater, 33321
        • Pfizer Investigational Site
      • Tampa, Florida, Forente stater, 33613
        • Pfizer Investigational Site
    • Georgia
      • Decatur, Georgia, Forente stater, 30033
        • Pfizer Investigational Site
      • Marietta, Georgia, Forente stater, 30060
        • Pfizer Investigational Site
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Pfizer Investigational Site
      • Oakbrook Terrace, Illinois, Forente stater, 60181
        • Pfizer Investigational Site
      • Rockford, Illinois, Forente stater, 61103-3692
        • Pfizer Investigational Site
      • Springfield, Illinois, Forente stater, 62702
        • Pfizer Investigational Site
      • Springfield, Illinois, Forente stater, 62703
        • Pfizer Investigational Site
      • Vernon Hills, Illinois, Forente stater, 60061
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, Forente stater, 47714
        • Pfizer Investigational Site
      • Indianapolis, Indiana, Forente stater, 46227
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, Forente stater, 67203
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40505
        • Pfizer Investigational Site
    • Massachusetts
      • Leominster, Massachusetts, Forente stater, 01453
        • Pfizer Investigational Site
      • Worcester, Massachusetts, Forente stater, 01605
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, Forente stater, 55435
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68516
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Forente stater, 12206
        • Pfizer Investigational Site
      • Orchard Park, New York, Forente stater, 14127
        • Pfizer Investigational Site
      • Rochester, New York, Forente stater, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28801
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Forente stater, 28210
        • Pfizer Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, Forente stater, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29601
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, Forente stater, 75235
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Forente stater, 98133
        • Pfizer Investigational Site
      • Tacoma, Washington, Forente stater, 98405
        • Pfizer Investigational Site
      • Tacoma, Washington, Forente stater, 98405-2308
        • Pfizer Investigational Site
    • West Virginia
      • Clarksburg, West Virginia, Forente stater, 26301
        • Pfizer Investigational Site
  • Hellas
      • Maroussi Athens, Hellas, 15126
        • Pfizer Investigational Site
  • Kina
      • Beijing, Kina, 100853
        • Pfizer Investigational Site
      • Beijing, Kina, 100020
        • Pfizer Investigational Site
      • Beijing, Kina, 100044
        • Pfizer Investigational Site
      • Shanghai, Kina, 200001
        • Pfizer Investigational Site
      • Shanghai, Kina, 200433
        • Pfizer Investigational Site
      • Shanghai, Kina, 200003
        • Pfizer Investigational Site
      • Tianjin, Kina, 300052
        • Pfizer Investigational Site
    • Anhui
      • Hefei, Anhui, Kina, 230022
        • Pfizer Investigational Site
      • Hefei, Anhui, Kina, 230001
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510630
        • Pfizer Investigational Site
      • Guangzhou, Guangdong, Kina, 510260
        • Pfizer Investigational Site
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Pfizer Investigational Site
    • Hunan
      • Changsha, Hunan, Kina, 410008
        • Pfizer Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • Pfizer Investigational Site
      • Suzhou, Jiangsu, Kina, 215006
        • Pfizer Investigational Site
    • Shandong
      • Jinan, Shandong, Kina, 250012
        • Pfizer Investigational Site
      • Qingdao, Shandong, Kina, 266011
        • Pfizer Investigational Site
    • Shanxi
      • Xi'an, Shanxi, Kina, 710032
        • Pfizer Investigational Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310009
        • Pfizer Investigational Site
  • Kroatia
      • Opatija, Kroatia, 51410
        • Pfizer Investigational Site
      • Zagreb, Kroatia, 10000
        • Pfizer Investigational Site
  • Malaysia
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Pfizer Investigational Site
      • Subang Jaya, Selangor, Malaysia, 47500
        • Pfizer Investigational Site
    • Wilayah Persekutuan
      • Putrajaya, Wilayah Persekutuan, Malaysia, 62250
        • Pfizer Investigational Site
  • Mexico
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • Pfizer Investigational Site
    • Michoacan
      • Morelia, Michoacan, Mexico, 58249
        • Pfizer Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62270
        • Pfizer Investigational Site
    • Queretaro
      • Mexico, Queretaro, Mexico, 76178
        • Pfizer Investigational Site
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Pfizer Investigational Site
  • Polen
      • Bialystok, Polen, 15-337
        • Pfizer Investigational Site
      • Bialystok, Polen, 15-461
        • Pfizer Investigational Site
      • Koscian, Polen, 64-000
        • Pfizer Investigational Site
      • Poznan, Polen, 60-773
        • Pfizer Investigational Site
      • Torun, Polen, 87-100
        • Pfizer Investigational Site
  • Slovakia
      • Nove Zamky, Slovakia, 94001
        • Pfizer Investigational Site
      • Poprad, Slovakia, 058 01
        • Pfizer Investigational Site
      • Povazska Bystrica, Slovakia, 017 01
        • Pfizer Investigational Site
      • Rimavska Sobota, Slovakia, 979 01
        • Pfizer Investigational Site
      • Senica, Slovakia, 905 01
        • Pfizer Investigational Site
      • Zilina, Slovakia, 010 01
        • Pfizer Investigational Site
  • Spania
      • A Coruña, Spania, 15006
        • Pfizer Investigational Site
      • Madrid, Spania, 28046
        • Pfizer Investigational Site
      • Malaga, Spania, 29009
        • Pfizer Investigational Site
      • Sevilla, Spania, 41013
        • Pfizer Investigational Site
    • A Coruña
      • Santiago de Compostela, A Coruña, Spania, 15705
        • Pfizer Investigational Site
  • Storbritannia
      • Newcastle Upon Tyne, Storbritannia, NE1 4LP
        • Pfizer Investigational Site
    • Merseyside
      • Wirral, Merseyside, Storbritannia, CH49 5PE
        • Pfizer Investigational Site
    • Staffs
      • Cannock, Staffs, Storbritannia, WS11 2XY
        • Pfizer Investigational Site
    • West Midlands
      • Solihull, West Midlands, Storbritannia, B91 2JL
        • Pfizer Investigational Site
  • Sverige
      • Falun, Sverige, 791 82
        • Pfizer Investigational Site
      • Goteborg, Sverige, 413 46
        • Pfizer Investigational Site
      • Uppsala, Sverige, 751 85
        • Pfizer Investigational Site
  • Thailand
    • Bangkok
      • Rajathevee, Bangkok, Thailand, 10400
        • Pfizer Investigational Site
    • Chiang Mai
      • Amphoe Muang, Chiang Mai, Thailand, 50200
        • Pfizer Investigational Site
    • Khonkaen
      • Muang District, Khonkaen, Thailand, 40002
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 14059
        • Pfizer Investigational Site
      • Dresden, Tyskland, 01067
        • Pfizer Investigational Site
      • Hamburg, Tyskland, 22081
        • Pfizer Investigational Site
      • Leipzig, Tyskland, 04103
        • Pfizer Investigational Site
      • Nuernberg, Tyskland, 90429
        • Pfizer Investigational Site
      • Rheine, Tyskland, 48431
        • Pfizer Investigational Site
  • Venezuela
    • DC/ Municipio Libertados
      • Caracas, DC/ Municipio Libertados, Venezuela, 1040-A
        • Pfizer Investigational Site
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela, 1010
        • Pfizer Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
  • Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
  • Patient must remain on at least one background traditional disease modifying antirheumatic drug.
  • No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

Exclusion Criteria:

  • Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
  • History of any other rheumatic autoimmune disease other than Sjogren's syndrome.
  • No malignancy or history of malignancy.
  • History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Aktiv 10 mg
Legemiddel: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Legemiddel: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Eksperimentell: Active 5 mg
Legemiddel: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Legemiddel: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Placebo komparator: Placebo Sequence 1
Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
Legemiddel: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Placebo komparator: Placebo Sequence 2
Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
Legemiddel: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i Health Assessment Questionnaire-Disability Index (HAQ-DI)-score ved måned 3
Tidsramme: Grunnlinje, måned 3
HAQ-DI: deltakerrapportert vurdering av evne til å utføre oppgaver i 8 kategorier av dagliglivsaktiviteter:kle seg/brudgommen;stå opp;spise; gå; nå; grep; hygiene; vanlige aktiviteter siste uke. Hvert element scoret på en 4-punkts skala fra 0-3:0=ingen vanskelighet;1=noe vanskeligheter;2=mye vanskeligheter;3=ikke i stand til å gjøre. Samlet poengsum ble beregnet som summen av domenepoeng og delt på antall besvarte domener. Totalt mulig poengsumsområde 0-3:0=minste vanskelighetsgrad og 3=ekstrem vanskelighetsgrad. For sammenligning av CP-690 550 med placebo, ble placebosekvenser kombinert til en enkelt rapporteringsgruppe for måned 3-analyse.
Grunnlinje, måned 3
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Tidsramme: Month 6
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); 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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Month 6
Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
Tidsramme: Month 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Month 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sykdomsaktivitetspoeng ved bruk av 28 leddtall og C-reaktivt protein (3 variabler) (DAS28-3 [CRP]) i måned 9 og 12
Tidsramme: Måned 9, 12
DAS28-3 (CRP) ble beregnet fra SJC og TJC ved å bruke 28 leddtellinger og CRP (mg/L). Total poengsum: 0 til 9,4, høyere poengsum indikerte mer sykdomsaktivitet. DAS28-3 (CRP) =<3,2 antydet lav sykdomsaktivitet, >3,2 til 5,1 antydet moderat til høy sykdomsaktivitet og <2,6 antydet remisjon.
Måned 9, 12
Pasientvurdering av leddgiktsmerte ved måned 9 og 12
Tidsramme: Måned 9, 12
Deltakerne vurderte alvorlighetsgraden av leddgiktsmerte på en 0 til 100 mm VAS, der 0 mm = ingen smerte og 100 mm = mest alvorlig smerte.
Måned 9, 12
Antall hendelser, inkludert besøk, operasjoner, tester eller enheter som er vurdert ved bruk av RA-HCRU ved baseline, måned 3 og 6
Tidsramme: Grunnlinje, måned 3, 6
RA-HCRU vurderte bruk av helsetjenester i løpet av de siste 3 månedene for direkte eller indirekte medisinske kostnadsdomener. Ethvert RA/ikke-RA-relatert antall hendelser, inkludert besøk til lege, ikke-lege, akuttbehandling på sykehus, sykehusinnleggelser, antall operasjoner, diagnostiske tester og utstyr/hjelpemidler som ble brukt, ble rapportert.
Grunnlinje, måned 3, 6
Antall hendelser inkludert besøk, operasjoner, tester eller enheter som er vurdert ved bruk av RA-HCRU ved måned 12
Tidsramme: Måned 12
RA-HCRU vurderte bruk av helsetjenester i løpet av de siste 3 månedene for direkte eller indirekte medisinske kostnadsdomener. Ethvert RA/ikke-RA-relatert antall hendelser, inkludert besøk til lege, ikke-lege, akuttbehandling på sykehus, sykehusinnleggelser, antall operasjoner, diagnostiske tester og utstyr/hjelpemidler som ble brukt, ble rapportert.
Måned 12
36-Item Short-Form Health Survey (SF-36) ved baseline, måned 1, 3 og 6
Tidsramme: Grunnlinje, måned 1, 3, 6
SF-36 er en standardisert undersøkelse som evaluerer 8 aspekter ved funksjonell helse og velvære: fysisk funksjon, rollefysisk, kroppslig smerte, generell helse, vitalitet, sosial funksjon, følelsesmessig og mental helse. Poengsummen for en seksjon er et gjennomsnitt av de individuelle spørsmålskårene, som skaleres 0-100 (100=høyeste funksjonsnivå) og rapporteres som 2 oppsummeringsskårer; fysisk komponentscore og mental komponentscore. Totalt poengområde for oppsummeringsskårene = 0-100, der høyere poengsum representerer høyere funksjonsnivå.
Grunnlinje, måned 1, 3, 6
Medical Outcomes Study Sleep Scale (MOS-SS) ved baseline, måned 1, 3 og 6
Tidsramme: Grunnlinje, måned 1, 3, 6
Deltaker-vurdert 12 element spørreskjema for å vurdere konstruksjoner av søvn siste uke.7 subskalaer: søvnforstyrrelser, snorking, vekket kortpustethet, søvntilstrekkelighet, somnolens (område: 0-100); søvnmengde (område: 0-24), optimal søvn (ja eller nei). 9 elementindeksmål for søvnforstyrrelser gir sammensatte poengsummer: oppsummering av søvnproblemer, generelt søvnproblem. Bortsett fra tilstrekkelighet, optimal, mengde søvn, høyere score=mer svekkelse. Poengsummer transformert(faktisk råscore(RS) minus lavest mulig poengsum delt på mulig RS-område*100);total poengsum:0-100,høyere poengsum=mer intensitet av attributtet.
Grunnlinje, måned 1, 3, 6
Antall deltakere med optimal søvn vurdert ved bruk av medisinske resultater Studer søvnskala (MOS-SS) ved baseline, måned 1, 3 og 6
Tidsramme: Grunnlinje, måned 1, 3, 6
MOS-SS: deltaker-vurdert 12-element spørreskjema for å vurdere konstruksjoner av søvn den siste uken. Den inkluderte 7 underskalaer: søvnforstyrrelse, snorking, vekket kortpustethet, søvntilstrekkelighet, somnolens, søvnmengde og optimal søvn. Deltakerne svarte om søvnen deres var optimal eller ikke ved å velge ja eller nei. Antall deltakere med optimal søvn rapporteres.
Grunnlinje, måned 1, 3, 6
Funksjonell vurdering av kronisk sykdomsterapi (FACIT)-tretthetsskala ved baseline, måned 1, 3 og 6
Tidsramme: Grunnlinje, måned 1, 3, 6
FACIT-Fatigue er et spørreskjema med 13 elementer. Deltakeren scoret hvert element på en 5-punkts skala: 0 (Ikke i det hele tatt) til 4 (Veldig mye). Jo større deltakerens svar på spørsmålene (med unntak av 2 negativt oppgitt), jo større blir trettheten. For alle spørsmål, bortsett fra de 2 negativt oppgitte, ble koden reversert og en ny poengsum ble beregnet til 4 minus deltakerens svar. Summen av alle svar resulterte i FACIT-Fatigue-score for en total mulig poengsum på 0 (dårlig poengsum) til 52 (bedre poengsum). En høyere poengsum reflekterte en forbedring i deltakerens helsestatus.
Grunnlinje, måned 1, 3, 6
Euro Quality of Life (EQ-5D) – Health State Profile Utility Score ved baseline, måned 3 og 6
Tidsramme: Grunnlinje, måned 3, 6
EQ-5D: deltaker vurdert spørreskjema for å vurdere helserelatert livskvalitet i form av en enkelt nyttepoengsum. Helsetilstandsprofilkomponent vurderer nivået på nåværende helse for 5 domener: mobilitet, egenomsorg, vanlige aktiviteter, smerte og ubehag, og angst og depresjon; 1 indikerer bedre helsetilstand (ingen problemer); 3 indikerer den verste helsetilstanden ("sengbundet"). Poengformel utviklet av EuroQol Group tildeler en nytteverdi for hvert domene i profilen. Poengsummen transformeres og resulterer i et totalt poengområde -0,594 til 1,000; høyere score indikerer en bedre helsetilstand.
Grunnlinje, måned 3, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Week 2, Month 1, 2, 3, 4.5, 6
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 HAQ); and CRP.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
Tidsramme: Month 9, 12
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 HAQ); and CRP.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Week 2, Month 1, 2, 3, 4.5, 6
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 HAQ); and CRP.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
Tidsramme: Month 9, 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 HAQ); and CRP.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Week 2, Month 1, 2, 3, 4.5, 6
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 HAQ); and CRP.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
Tidsramme: Month 9, 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 HAQ); and CRP.
Month 9, 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Week 2, Month 1, 2, 3, 4.5, 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Week 2, Month 1, 2, 3, 4.5, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6
Tidsramme: Baseline, Month 3, 6
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Baseline, Month 3, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
Tidsramme: Month 12
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Month 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Tidsramme: Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Tidsramme: Baseline, Month 3, 6, 12
DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Baseline, Month 3, 6, 12
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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 2, Month 1, 2, 3, 4.5, 6
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
Tidsramme: Month 9, Month 12
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.
Month 9, Month 12
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Tidsramme: Month 9, 12
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Month 9, 12
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Tidsramme: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
Tidsramme: Month 9, 12
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Month 9, 12
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Tidsramme: Month 9, 12
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Month 9, 12
Medical Outcome Study (MOS) Sleep Scale at Month 12
Tidsramme: Month 12
Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Month 12
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
Tidsramme: Month 12
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Month 12
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
Tidsramme: Month 12
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Month 12
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
Tidsramme: Month 12
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Month 12
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
Tidsramme: Baseline, Month 3, 6
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Baseline, Month 3, 6
Work Limitations Questionnaire (WLQ) Score at Month 12
Tidsramme: Month 12
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Month 12
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Tidsramme: Baseline, Month 3, 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Baseline, Month 3, 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Tidsramme: Month 12
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Month 12
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Tidsramme: Baseline, Month 3, 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Baseline, Month 3, 6
Number of Days as Assessed Using RA-HCRU at Month 12
Tidsramme: Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Month 12
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Tidsramme: Baseline, Month 3, 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Baseline, Month 3, 6
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Tidsramme: Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Month 12
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Tidsramme: Baseline, Month 3, 6
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Baseline, Month 3, 6
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Tidsramme: Month 12
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Month 12

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Tidsramme: 2 weeks
Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
2 weeks
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Tidsramme: 2 weeks
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
2 weeks

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Studer hoveddatoer

Studiestart

1. mai 2009

Primær fullføring (Faktiske)

1. januar 2011

Studiet fullført (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først innsendt

3. mars 2009

Først innsendt som oppfylte QC-kriteriene

3. mars 2009

Først lagt ut (Anslag)

5. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. desember 2012

Sist bekreftet

1. desember 2012

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Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A3921046

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