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Remission and Joint Damage Progression in Early Rheumatoid Arthritis

3. november 2010 opdateret af: Bristol-Myers Squibb

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1052

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Victoria
      • Malvern, Victoria, Australien, 3144
        • Local Institution
    • Western Australia
      • Shenton Park, Western Australia, Australien, 6008
        • Local Institution
  • Belgien
      • Antwerpen, Belgien, 2020
        • Local Institution
      • Bruxelles, Belgien, 1200
        • Local Institution
      • Bruxelles, Belgien, 1070
        • Local Institution
      • Hasselt, Belgien, 3500
        • Local Institution
      • Leuven, Belgien, 3000
        • Local Institution
  • Brasilien
      • Sao Paulo, Brasilien, 04039
        • Local Institution
      • Sao Paulo, Brasilien, 04230
        • Local Institution
    • Goias
      • Goiania, Goias, Brasilien, 74043
        • Local Institution
    • Parana
      • Curitiba, Parana, Brasilien, 80060
        • Local Institution
    • Rio De Janeiro
      • Rio De Janeiro - Rj, Rio De Janeiro, Brasilien, 20551
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 91610
        • Local Institution
  • Canada
      • Quebec, Canada, G1V 3M7
        • Local Institution
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada, A1B 3E1
        • Local Institution
    • Ontario
      • Kitchener, Ontario, Canada, N2M 5N6
        • Local Institution
      • Toronto, Ontario, Canada, M5G 1X5
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2L 1S6
        • Local Institution
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Local Institution
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 115522
        • Local Institution
      • Moscow, Den Russiske Føderation, 119049
        • Local Institution
  • Det Forenede Kongerige
    • Greater Manchester
      • Manchester, Greater Manchester, Det Forenede Kongerige, M13 9WL
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, Det Forenede Kongerige, G12 0YN
        • Local Institution
    • North Yorkshire
      • Leeds, North Yorkshire, Det Forenede Kongerige, LS7 4SA
        • Local Institution
    • Northumberland
      • Newcastle, Northumberland, Det Forenede Kongerige, NE1 4LP
        • Local Institution
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35801
        • Rheumatology Associates of North Alabama
    • California
      • Huntington Beach, California, Forenede Stater, 92646
        • Talbert Medical Group
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80910
        • Arthritis Assoc And Osteo Ctr Of Col Sprgs
    • Connecticut
      • Trumbull, Connecticut, Forenede Stater, 06611
        • New England Research Associates, LLC
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46227
        • Diagnostic Rheumatology and Research
    • Maryland
      • Cumberland, Maryland, Forenede Stater, 21502
        • Osteoporosis and Clinical Trials Center
      • Hagerstown, Maryland, Forenede Stater, 21740
        • Malamet & Klein, MD, PA
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Arthritis Center of Nebraska
    • New York
      • Binghamton, New York, Forenede Stater, 13905
        • Regional Rheumatology Associates
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Carolina Bone & Joint
      • Greenville, North Carolina, Forenede Stater, 27834
        • Physicians East, PA
      • Statesville, North Carolina, Forenede Stater, 28625
        • Carolina Pharmaceutical Research
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73071
        • Lion Research
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Lynn Health Sciences Institute
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Low Country Research Center
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Walter F Chase Md Pa
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22205
        • Arthritis Clinic Of Northern Virginia, P.C.
  • Frankrig
      • Dijon, Frankrig, 21000
        • Local Institution
      • Montpellier Cedex 5, Frankrig, 34295
        • Local Institution
      • Nice Cedex 03, Frankrig, 06202
        • Local Institution
      • Strasbourg Cedex, Frankrig, 67098
        • Local Institution
  • Holland
      • Amsterdam, Holland, 1081 HV
        • Local Institution
      • Leiden, Holland, 2300 RC
        • Local Institution
      • Nijmegen, Holland, 6500 HB
        • Local Institution
  • Italien
      • Jesi(Ancona), Italien, 60055
        • Local Institution
      • Milano, Italien, 20157
        • Local Institution
  • Korea, Republikken
      • Anyang, Korea, Republikken, 431-070
        • Local Institution
      • Daegu, Korea, Republikken, 705-718
        • Local Institution
      • Daejeon, Korea, Republikken, 302-799
        • Local Institution
      • Seoul, Korea, Republikken, 110-744
        • Local Institution
      • Seoul, Korea, Republikken, 137-040
        • Local Institution
      • Seoul, Korea, Republikken, 138-736
        • Local Institution
      • Seoul, Korea, Republikken, 133-792
        • Local Institution
  • Mexico
      • Chihuahua, Mexico, 31000
        • Local Institution
      • San Luis Potosi, Mexico, 78240
        • Local Institution
    • Distrito Federal
      • D.f., Distrito Federal, Mexico, 06700
        • Local Institution
    • Estado De Mexico
      • Metepec, Estado De Mexico, Mexico, 52140
        • Local Institution
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44690
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 42650
        • Local Institution
    • Michioacan
      • Morelia, Michioacan, Mexico, 58000
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62270
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64020
        • Local Institution
  • Polen
      • Poznan, Polen, 60773
        • Local Institution
      • Poznan, Polen, 61-545
        • Local Institution
      • Warszawa, Polen, 02-637
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Local Institution
  • Spanien
      • A Coruna, Spanien, 15706
        • Local Institution
      • Santander, Spanien, 39008
        • Local Institution
      • Sevilla, Spanien, 41071
        • Local Institution
  • Sydafrika
    • Free State
      • Bloemfontein, Free State, Sydafrika, 9317
        • Local Institution
    • Gauteng
      • Muckleneuk, Gauteng, Sydafrika, 0002
        • Local Institution
      • Pretoria, Gauteng, Sydafrika, 0084
        • Local Institution
    • Kwa Zulu Natal
      • Berea, Kwa Zulu Natal, Sydafrika, 4001
        • Local Institution
    • Western Cape
      • Panorama, Western Cape, Sydafrika, 7506
        • Local Institution
  • Tjekkiet
      • Prague 2, Tjekkiet, 128 50
        • Local Institution
  • Tyskland
      • Berlin, Tyskland, 14059
        • Local Institution
      • Hamburg, Tyskland, 22081
        • Local Institution
      • Leipzig, Tyskland, 04103
        • Local Institution
      • Leipzig, Tyskland, 04229
        • Local Institution

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent.
  • C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)
  • Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
  • Tender joints >=12 and swollen joints >=10

Exclusion Criteria:

  • Women and men who are not willing to use birth control
  • Diagnosed with other rheumatic disease
  • History of cancer within 5 years
  • Active tuberculosis
  • Treatment with another investigation drug within 28 days
  • Active bacterial or viral infection

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: ABA + MTX
abatacept 10 mg/kg intravenous (IV) + methotrexate
Medicin: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
Medicin: methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Aktiv komparator: Placebo (PLA) + MTX
placebo IV + methotrexate
Medicin: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
Medicin: methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Medicin: placebo
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12
Tidsramme: Month 12
Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.
Month 12
Mean Change From Baseline in Radiographic Total Score to Month 12
Tidsramme: Baseline, Month 12
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Baseline, Month 12
Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period
Tidsramme: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With Serious Adverse Events Reported During the Open-Label Period
Tidsramme: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With SAEs With an Outcome of Death During the Open-label Period
Tidsramme: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Any untoward medical occurrence (SAE) that resulted in death
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Incidence Rates of Autoimmune Disorders in ABA-Treated Participants
Tidsramme: Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).
The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.
Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).
Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants
Tidsramme: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.
Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants
Tidsramme: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.
Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period
Tidsramme: Open-Label Period (Month 12 to Month 24)
There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.
Open-Label Period (Month 12 to Month 24)
Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
Tidsramme: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
Tidsramme: Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL
Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12
Tidsramme: Month 12
ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].
Month 12
Number of Participants With Major Clinical Response (MCR) at Month 12
Tidsramme: Month 12
MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).
Month 12
Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12
Tidsramme: Baseline, Month 12
DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.
Baseline, Month 12
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12
Tidsramme: Month 12
Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.
Month 12
Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12
Tidsramme: Baseline, Month 12
The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.
Baseline, Month 12
Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12
Tidsramme: Baseline, Month 12
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value
Baseline, Month 12
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)
Tidsramme: includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.
Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).
includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA
Tidsramme: Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).
Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24
Tidsramme: Baseline, Month 24
Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.
Baseline, Month 24
Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24
Tidsramme: Baseline, Month 24
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.
Baseline, Month 24
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24
Tidsramme: Baseline, Month 24
Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Baseline, Month 24
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12
Tidsramme: Month 12, Month 24
Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Month 12, Month 24
Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)
Tidsramme: Baseline, Month 12, Month 24
Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Baseline, Month 12, Month 24
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period
Tidsramme: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.
Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period
Tidsramme: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.
Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria
Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2005

Primær færdiggørelse (Faktiske)

1. februar 2008

Studieafslutning (Faktiske)

1. februar 2009

Datoer for studieregistrering

Først indsendt

19. juli 2005

Først indsendt, der opfyldte QC-kriterier

19. juli 2005

Først opslået (Skøn)

22. juli 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. november 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2010

Sidst verificeret

1. november 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IM101-023

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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