Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

keskiviikko 16. heinäkuuta 2014 päivittänyt: Hoffmann-La Roche

Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

556

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Alankomaat
      • Amsterdam, Alankomaat, 1105 AZ
      • Amsterdam, Alankomaat, 1081 HV
      • Leiden, Alankomaat, 2333 ZA
      • Maastricht, Alankomaat, 6202 AZ
      • Nijmegen, Alankomaat, 6525 GA
      • Utrecht, Alankomaat, 3584 CX
  • Brasilia
    • MG
      • Belo Horizonte, MG, Brasilia, 30130-100
    • RS
      • Porto Alegre, RS, Brasilia, 90035-903
    • SP
      • Sao Paulo, SP, Brasilia, 05403-000
      • Sao Paulo, SP, Brasilia, 04026-000
      • Sao Paulo, SP, Brasilia, 04039-004
  • Espanja
      • Barcelona, Espanja, 08003
      • Madrid, Espanja, 28046
      • Madrid, Espanja, 28041
      • Madrid, Espanja, 28007
      • Madrid, Espanja, 28222
      • Sevilla, Espanja, 41009
    • Asturias
      • Oviedo, Asturias, Espanja, 33006
    • La Coruña
      • La Coruna, La Coruña, Espanja, 15006
      • Santiago De Compostela, La Coruña, Espanja, 15706
    • Madrid
      • Leganes, Madrid, Espanja, 28191
    • Vizcaya
      • Bilbao, Vizcaya, Espanja, 48013
  • Israel
      • Afula, Israel, 18101
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 31048
      • Haifa, Israel, 34362
      • Haifa, Israel, 34354
      • Kfar Saba, Israel, 44281
      • Ramat-Gan, Israel, 52621
      • Rishon Lezion, Israel
      • Tel Aviv, Israel, 6423906
  • Italia
      • Ancona, Italia, 60020
      • Bari, Italia, 70124
      • Perugia, Italia, 06122
      • Prato, Italia, 59100
      • Roma, Italia, 00168
  • Kreikka
      • Athens, Kreikka, 11527
      • Thessaloniki, Kreikka, 54642
      • Thessaloniki, Kreikka, 54636
  • Kroatia
      • Rijeka, Kroatia, 51000
      • Zagreb, Kroatia, 10000
  • Latvia
      • Bauska, Latvia, 3901
      • Daugavpils, Latvia, 5417
      • Liepaja, Latvia, 3400
      • Riga, Latvia, LV-1002
      • Riga, Latvia, 1038
      • Riga, Latvia, 1006
  • Norja
      • Drammen, Norja, 3004
      • Gjettum, Norja, 1346
      • Kristiansand, Norja, 4604
      • Lillehammer, Norja, 2609
      • Moss, Norja, 1535
      • Oslo, Norja, 0319
  • Ranska
      • Abbeville, Ranska, 80142
      • Boulogne-billancourt, Ranska, 92104
      • Brest, Ranska, 29609
      • Echirolles, Ranska, 38434
      • Le Kremlin Bicetre, Ranska, 94275
      • Le Mans, Ranska, 72037
      • Marseille, Ranska, 13285
      • Marseille, Ranska, 13385
      • Monaco, Ranska, 98012
      • Nantes, Ranska, 44035
      • Nice, Ranska, 06202
      • Paris, Ranska, 75571
      • Paris, Ranska, 75679
      • Pierre Benite, Ranska, 69495
      • Vandoeuvre-les-nancy, Ranska, 54511
  • Romania
      • Bucharest, Romania, 011172
      • Bucuresti, Romania, 020983
  • Ruotsi
      • Goeteborg, Ruotsi, 41345
      • Umea, Ruotsi, 90185
  • Saksa
      • Aachen, Saksa, 52064
      • Berlin, Saksa, 10117
      • Berlin, Saksa, 13125
      • Dresden, Saksa, 01307
      • Erlangen, Saksa, 91054
      • Hamburg, Saksa, 22081
      • Jena, Saksa, 07747
      • Köln, Saksa, 50924
      • Muenchen, Saksa, 80336
      • Ratingen, Saksa, 40882
      • Wuerzburg, Saksa, 97080
  • Serbia
      • Belgrade, Serbia, 11000
      • Kragujevac, Serbia, 34000
      • Niska Banja, Serbia, 18250
      • Nova sad, Serbia, 21000
  • Tanska
      • Frederiksberg, Tanska, 2000
      • Hellerup, Tanska, 2900
      • Køge, Tanska, 4600
  • Thaimaa
      • Bangkok, Thaimaa, 10300
      • Khon Kaen, Thaimaa, 40002
      • Pathumthani, Thaimaa, 12120
  • Venäjän federaatio
      • Barnaul, Venäjän federaatio, 656024
      • Ekaterinburg, Venäjän federaatio, 620102
      • Irkutsk, Venäjän federaatio, 664047
      • Izhevsk, Venäjän federaatio, 426009
      • Kazan, Venäjän federaatio, 420012
      • Khanty-Mansiysk, Venäjän federaatio, 628011
      • Kursk, Venäjän federaatio, 305007
      • Moscow, Venäjän federaatio, 115522
      • Novosibirsk, Venäjän federaatio, 630117
      • Novosibirsk, Venäjän federaatio, 630099
      • St Petersburg, Venäjän federaatio, 191015
      • Tjumen, Venäjän federaatio, 625023
      • UFA, Venäjän federaatio, 450005
      • Ulyanovsk, Venäjän federaatio, 432063
      • Vladivostok, Venäjän federaatio, 690105
  • Viro
      • Tallinn, Viro, 11312
      • Tallinn, Viro, 13419
  • Yhdistynyt kuningaskunta
      • Cannock, Yhdistynyt kuningaskunta, WS11 5XY
      • Glasgow, Yhdistynyt kuningaskunta, G12 0YN
      • Leeds, Yhdistynyt kuningaskunta, LS7 4SA
      • London, Yhdistynyt kuningaskunta, SE5 9RS
      • Newcastle-upon-Tyne, Yhdistynyt kuningaskunta, NE2 4HH
      • Norwich, Yhdistynyt kuningaskunta, NR4 7UY
  • Yhdysvallat
    • California
      • Santa Monica, California, Yhdysvallat, 90404
      • Upland, California, Yhdysvallat, 91786
      • Whittier, California, Yhdysvallat, 90606
    • Florida
      • Aventura, Florida, Yhdysvallat, 33180
      • Naples, Florida, Yhdysvallat, 34102
      • Orange Park, Florida, Yhdysvallat, 32073
      • Plantation, Florida, Yhdysvallat, 33317
      • Sarasota, Florida, Yhdysvallat, 34239
      • South Miami, Florida, Yhdysvallat, 33143
      • Tamarac, Florida, Yhdysvallat, 33321
    • Minnesota
      • Eagan, Minnesota, Yhdysvallat, 55121
    • Nevada
      • Las Vegas, Nevada, Yhdysvallat, 89128
    • Ohio
      • Mayfield, Ohio, Yhdysvallat, 44143
      • Middleburg Heights, Ohio, Yhdysvallat, 44130
    • Oklahoma
      • Oklahoma City, Oklahoma, Yhdysvallat, 73104
    • Pennsylvania
      • West Reading, Pennsylvania, Yhdysvallat, 19611
    • South Carolina
      • Greenville, South Carolina, Yhdysvallat, 29601
    • Tennessee
      • Nashville, Tennessee, Yhdysvallat, 37205
    • Texas
      • Houston, Texas, Yhdysvallat, 77004
      • San Antonio, Texas, Yhdysvallat, 78217
    • Washington
      • Spokane, Washington, Yhdysvallat, 99204

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:

  • adult patients, ≥ 18 years of age;
  • moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) > 4.4);
  • inadequate response to methotrexate;
  • on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.

Exclusion Criteria:

  • prior treatment with a biologic;
  • Rheumatoid arthritis (RA) functional class IV;
  • known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
  • evidence of active malignant disease.

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: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Tocilizumab + Methotrexate
Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drugs (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
Lääke: tocilizumab [RoActemra/Actemra]
tocilizumab 8 mg IV every 4 weeks.
Muut nimet:
  • RoActemra/Actemra
Lääke: methotrexate
Approximately 15-17 mg methotrexate capsule orally once a week.
Placebo Comparator: Tocilizumab + Placebo
Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
Lääke: tocilizumab [RoActemra/Actemra]
tocilizumab 8 mg IV every 4 weeks.
Muut nimet:
  • RoActemra/Actemra
Lääke: placebo
Placebo matching methotrexate capsule taken orally once a week.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24
Aikaikkuna: Week 24
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.
Week 24

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With American College of Rheumatology (ACR20) Response
Aikaikkuna: Baseline, Weeks 24, 52, 104
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
Baseline, Weeks 24, 52, 104
Percentage of Participants With ACR50 Response
Aikaikkuna: Baseline, Weeks 24, 52, 104
ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
Baseline, Weeks 24, 52, 104
Percentage of Participants With ACR70 Response
Aikaikkuna: Baseline, Weeks 24, 52, 104
ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
Baseline, Weeks 24, 52, 104
Percentage of Participants With ACR90 Response
Aikaikkuna: Baseline, Weeks 24, 52, 104
ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
Baseline, Weeks 24, 52, 104
Time to First ACR20 Response
Aikaikkuna: 104 Weeks
Time in days from first administration of study drug until ACR20 response. ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
104 Weeks
Time to First ACR50 Response
Aikaikkuna: 104 Weeks
Time in days from first administration of study drug until ACR50 response. ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate).
104 Weeks
Time to First ACR70 Response
Aikaikkuna: 104 Weeks
Time in days from first administration of study drug until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
104 Weeks
Time to First ACR90 Response
Aikaikkuna: 104 Weeks
Time in days from first administration of study drug until ACR90 response. ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].
104 Weeks
Area Under Curve (AUC) DAS28
Aikaikkuna: Baseline to Week 24
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. AUC DAS28 was averaged over study days. Analysis of Covariance was adjusted for Baseline DAS28 as a covariate and treatment group and region as fixed factors. Higher calculated AUC values are worse (indicate higher disease activity).
Baseline to Week 24
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission
Aikaikkuna: Week 52
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.
Week 52
Percentage of Participants With DAS28 Low Disease Activity (LDAS)
Aikaikkuna: Weeks 24, 52
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2.
Weeks 24, 52
Change From Baseline in DAS28 Score
Aikaikkuna: Baseline, Weeks 24, 52
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52
Percentage of Participants With Good or Moderate European League (EULAR) DAS28 Responses
Aikaikkuna: Baseline, 24, 52

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.

European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2.

EULAR Moderate response: DAS28 > 3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.
Baseline, 24, 52
Change From Baseline in Swollen Joint Count
Aikaikkuna: Baseline, Weeks 24, 52
66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52
Change From Baseline in Tender Joint Count
Aikaikkuna: Baseline, Weeks 24, 52
68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52
Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (VAS)
Aikaikkuna: Baseline, Weeks 24, 52
The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52
Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale (VAS)
Aikaikkuna: Baseline, Weeks 24, 52
The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52
Change From Baseline in Patient Global Assessment of Pain (VAS)
Aikaikkuna: Baseline, Weeks 24, 52
The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Aikaikkuna: Baseline, Weeks 24, 52
Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.
Baseline, Weeks 24, 52
Change From Baseline in C-Reactive Protein (CRP)
Aikaikkuna: Baseline, Weeks 24, 52
Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.
Baseline, Weeks 24, 52
Change From Baseline in the Health Assessment Questionnaire Disability Index
Aikaikkuna: Baseline, Weeks 24, 52
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52
Change From Baseline in Total Genant Modified Sharp Scores (GSS)
Aikaikkuna: Baseline, Weeks 24, 52, 104
Radiographs were taken of each hand and foot at Baseline, Weeks 24, 52 and104 and were evaluated using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 98 and in the feet 42. The maximum scores for joint space narrowing (JSN) in the hands was104 and in the feet 48. The total score was the sum of scores for erosions and JSN. The maximum total modified GSS was 292. A lower number change from Baseline was better. Analysis of covariance model, with Baseline DAS28 as a covariate and treatment and site as fixed factors.
Baseline, Weeks 24, 52, 104
Change From Baseline in Joint Space Narrowing Score
Aikaikkuna: Baseline, Weeks 24, 52, 104
A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum scores for joint space narrowing (JSN) in the hands was 104 and in the feet 48 for a total possible score of 0 to 152. A lower change from Baseline indicated a better score. Analysis of covariance model included baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.
Baseline, Weeks 24, 52, 104
Change From Baseline in Erosion Score
Aikaikkuna: Baseline, Weeks 24, 52, 104
A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. The maximum erosion score in the hands was 98 and in the feet 42 for a total possible score of 0 to 140. A lower number change from Baseline indicated a better score.
Baseline, Weeks 24, 52, 104
Percentage of Participants Discontinuing Tocilizumab Due to Remission
Aikaikkuna: Weeks 52, 104
The percentage of participants who stopped treatment with tocilizumab due to remission.
Weeks 52, 104
Percentage of Participants Who Withdrew Due to Lack of Sufficient Therapeutic Response
Aikaikkuna: Up to 3 years
Lack of Sufficient Therapeutic Response was defined as the patient not responding to the drug as expected.
Up to 3 years
Percentage of Participants Who Withdrew Due to Safety Reasons
Aikaikkuna: Up to 3 years
Safety reasons were defined as adverse events, intercurrent illness or death. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
Up to 3 years
Change From Baseline in Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)
Aikaikkuna: Baseline, Weeks 24, 52, 104
The RAQoL is a disease specific patient-reported outcome measure that determines the effect rheumatoid arthritis has on a patient's quality of life consisting of 30 questions that are answered either yes=1 or no=0 for a total possible score ranging from 0 (best) to 30 (worst). A negative change from Baseline indicated improvement.
Baseline, Weeks 24, 52, 104
Change From Baseline in Academic Medical Center (AMC) Linear Disability Scale (ALDS)
Aikaikkuna: Baseline, Weeks 104
The Academic Medical Center (AMC) Linear Disability Score (ALDS) evaluates the participant's ability to perform activities of daily life consisting of 77 questions answered yes or no . The question difficulty and the patient's ability are arranged on a single hierarchical linear scale. ALDS scores range from 10 to 90 with a higher score representing higher functional status. A positive change from Baseline indicated improvement.
Baseline, Weeks 104
Area Under the Curve (AUC) From Baseline to Week 24 for ACR Response
Aikaikkuna: Baseline to Week 24
ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. Area under the curve for ACR response to Week 24 was averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (≤ 5.5 and > 5.5) as fixed factors.
Baseline to Week 24
Area Under the Curve (AUC) From Baseline to Week 52 for ACR Response
Aikaikkuna: Baseline to Week 52
ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].Area under the curve for ACR response to Week 52 averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (<=5.5 and >5.5) as fixed factors.
Baseline to Week 52
Time to Tocilizumab Remission
Aikaikkuna: 104 Weeks
The time in days from initial study drug treatment to tocilizumab remission that occurred when the patient discontinued treatment with tocilizumab.
104 Weeks
Time to Drug-Free Remission
Aikaikkuna: 104 Weeks
The time in days from initial study drug treatment to drug free remission that occurred when the participant was able to discontinue tocilizumab, methotrexate/placebo and open label disease-modifying antirheumatic drugs (DMARDS).
104 Weeks
Time to Flare After Tocilizumab Remission
Aikaikkuna: 104 Weeks
The time in days to a flare (recurrence of disease symptoms) after the patient discontinued treatment with tocilizumab.
104 Weeks
Time to Restart of Treatment After Discontinuation/Remission
Aikaikkuna: 104 Weeks
The time in days from treatment discontinuation or remission to the restart of treatment.
104 Weeks

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hoffmann-La Roche

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

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

Sunnuntai 1. maaliskuuta 2009

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. elokuuta 2010

Opintojen valmistuminen (Todellinen)

Tiistai 1. tammikuuta 2013

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 16. joulukuuta 2008

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 16. joulukuuta 2008

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 17. joulukuuta 2008

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Perjantai 18. heinäkuuta 2014

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 16. heinäkuuta 2014

Viimeksi vahvistettu

Tiistai 1. heinäkuuta 2014

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • MA21488
  • 2008-001847-20

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 Nivelreuma

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Hong Kong

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

3
Tilaa