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Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

9. prosince 2015 aktualizováno: Bristol-Myers Squibb

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

511

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
    • Queensland
      • Cairns, Queensland, Austrálie, 4870
        • Local Institution
      • Maroochydore, Queensland, Austrálie, 4558
        • Local Institution
    • South Australia
      • Woodville, South Australia, Austrálie, 5011
        • Local Institution
    • Victoria
      • Heidelberg, Victoria, Austrálie, 3084
        • Local Institution
      • Malvern, Victoria, Austrálie, 3144
        • Local Institution
    • Western Australia
      • Victoria Park, Western Australia, Austrálie, 6100
        • Local Institution
  • Belgie
      • Bruxelles, Belgie, 1200
        • Local Institution
      • Kortrijk, Belgie, 8500
        • Local Institution
      • Merksem, Belgie, 2170
        • Local Institution
  • Dánsko
      • Hjorring, Dánsko, 9800
        • Local Institution
  • Finsko
      • Helsinki, Finsko, 00290
        • Local Institution
      • Tampere, Finsko, 33521
        • Local Institution
  • Francie
      • Chambray Les Tours, Francie, 37170
        • Local Institution
      • Montpellier, Francie, 34295
        • Local Institution
      • Paris Cedex 14, Francie, 75679
        • Local Institution
      • Poitiers, Francie, 86021
        • Local Institution
  • Itálie
      • Ancona, Itálie, 60055
        • Local Institution
      • Siena, Itálie, 53100
        • Local Institution
  • Jižní Afrika
    • Gauteng
      • Kempton Park, Gauteng, Jižní Afrika, 1619
        • Local Institution
      • Pretoria, Gauteng, Jižní Afrika, 0083
        • Local Institution
      • Pretoria, Gauteng, Jižní Afrika, 0084
        • Local Institution
      • Pretoria, Gauteng, Jižní Afrika, 0181
        • Local Institution
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, Jižní Afrika, 4001
        • Local Institution
    • Western Cape
      • Panorama, Western Cape, Jižní Afrika, 7500
        • Local Institution
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4N1
        • Local Institution
    • Quebec
      • Laval, Quebec, Kanada, H7T 2P5
        • Local Institution
  • Korejská republika
      • Daegu, Korejská republika, 705-718
        • Local Institution
      • Daejeon, Korejská republika, 302-799
        • Local Institution
      • Seoul, Korejská republika, 137-701
        • Local Institution
      • Seoul, Korejská republika, 133-791
        • Local Institution
  • Mexiko
      • Chihuahua, Mexiko, 31000
        • Local Institution
      • Queretaro, Mexiko, 76178
        • Local Institution
      • San Luis Potosi, Mexiko, 78240
        • Local Institution
    • Estado De Mexico
      • Metepec, Estado De Mexico, Mexiko, 52140
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44500
        • Local Institution
      • Guadalajara, Jalisco, Mexiko, 44690
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexiko, 64020
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexiko, 97000
        • Local Institution
  • Německo
      • Berlin, Německo, 10117
        • Local Institution
      • Berlin, Německo, 14059
        • Local Institution
      • Hildesheim, Německo, 31134
        • Local Institution
      • Muenchen, Německo, 80336
        • Local Institution
      • Muenchen, Německo, 80639
        • Local Institution
      • Muenchen, Německo, 81541
        • Local Institution
  • Polsko
      • Lublin, Polsko, 20-954
        • Local Institution
      • Poznan, Polsko, 60-218
        • Local Institution
      • Torun, Polsko, 87100
        • Local Institution
      • Warszawa, Polsko, 01-157
        • Local Institution
      • Warszawa, Polsko, 01-868
        • Local Institution
      • Wroc#aw, Polsko, 50-088
        • Local Institution
  • Ruská Federace
      • Moscow, Ruská Federace, 117049
        • Local Institution
      • Moscow, Ruská Federace, 129327
        • Local Institution
      • Tver, Ruská Federace, 170036
        • Local Institution
  • Spojené státy
    • Alabama
      • Huntsville, Alabama, Spojené státy, 35801
        • Rheumatology Associates Of North Alabama, P.C.
    • Arkansas
      • Hot Springs, Arkansas, Spojené státy, 71913
        • St. Joseph'S Mercy Clinic
    • Florida
      • Sarasota, Florida, Spojené státy, 34239
        • Sarasota Arthritis Research Center
    • Idaho
      • Coeur D Alene, Idaho, Spojené státy, 83814
        • Coeur D'Alene Arthrit Clin
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21224
        • Johns Hopkins University Division of Rheumatology
    • Massachusetts
      • Worcester, Massachusetts, Spojené státy, 01605
        • Clinical Pharmacology Study Group
    • Mississippi
      • Jackson, Mississippi, Spojené státy, 39202
        • Arthritis Associates Of Mississippi
    • Nebraska
      • Lincoln, Nebraska, Spojené státy, 68516
        • Physician Research Collaboration, LLC
    • North Carolina
      • Hickory, North Carolina, Spojené státy, 28602
        • Piedmont Rheumatology, Pa
      • Wilmington, North Carolina, Spojené státy, 28401
        • Carolina Arthritis Associates
    • Ohio
      • Cleveland, Ohio, Spojené státy, 44109
        • MetroHealth Medical Center
      • Middleburg, Ohio, Spojené státy, 44130
        • Isam A. Diab, Md
    • Pennsylvania
      • Duncansville, Pennsylvania, Spojené státy, 16635
        • Alan J. Kivitz, Md, Cpi
    • South Carolina
      • Orangeburg, South Carolina, Spojené státy, 29118
        • Mitchell C. Feinman, Md
    • Wisconsin
      • Glendale, Wisconsin, Spojené státy, 53217
        • Kurt Oelke, Md
  • Švédsko
      • Goteborg, Švédsko, 413 45
        • Local Institution
      • Linkoping, Švédsko, 581 85
        • Local Institution
      • Malmo, Švédsko, 205 02
        • Local Institution
      • Stockholm, Švédsko, 171 76
        • Local Institution
      • Uppsala, Švédsko, 751 85
        • Local Institution

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Key Inclusion Criteria:

  • Presence of active clinical synovitis in at least 2 joints, 1 of which must have been a small joint, for a minimum of 8 weeks prior to screening
  • Onset of persistent symptoms ≤ 2 years prior to screening
  • Positive test result for anticyclic citrullinated peptides 2
  • Methotrexate naive or with minimum exposure to methotrexate, defined as no more than 10 mg/week for ≤4 weeks and no methotrexate dose for 1 month prior to screening visit
  • Biologic naive, including no treatment with an investigational biologic prior to screening
  • Disease Activity Score 28 based on C-reactive protein score ≥3.2 at screening
  • Withdrawal from any treatment with chloroquine, hydroxychloroquine, and/or sulfasalazine (wash-out) for a minimum of 28 days prior to randomization
  • If receiving oral corticosteroids, on a stable low dose (≤ 10 mg/day prednisone equivalent) for at least 4 weeks
  • Able to undergo magnetic resonance imaging

Key Exclusion Criteria:

  • Meeting diagnostic criteria for other rheumatic disease (eg, lupus erythematosus)
  • Treatment with an intravenous, intramuscular, or intraarticular corticosteroid within 4 weeks prior to randomization
  • Scheduled for or anticipating joint replacement surgery
  • Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
  • History of malignancy in the last 5 years
  • Any serious bacterial infection within the last 3 months not treated or resolved with antibiotics, or any chronic or recurrent bacterial infection
  • At risk for tuberculosis
  • Evidence of active or latent bacterial or viral infection at the time of potential enrollment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrollment

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Abatacept, 125 mg, plus methotrexate, 2.5 mg
Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
Lék: Abatacept
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Ostatní jména:
  • Orencia
  • BMS 188667
Lék: Methotrexate
Tablets, oral, 2.5 mg, once weekly, 12 months
Ostatní jména:
  • Rheumatrex
Aktivní komparátor: Methotrexate, 2.5 mg, plus abatacept placebo
Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
Lék: Methotrexate
Tablets, oral, 2.5 mg, once weekly, 12 months
Ostatní jména:
  • Rheumatrex
Lék: Abatacept placebo
Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months
Aktivní komparátor: Abatacept, 125 mg, plus methotrexate placebo
Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
Lék: Abatacept
Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
Ostatní jména:
  • Orencia
  • BMS 188667
Lék: Methotrexate placebo
Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
Časové okno: Randomization to Months 12 and 18
DAS28-CRP remission defined as <2.6; TP=treatment phase; WP=withdrawal phase. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Randomization to Months 12 and 18

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18
Časové okno: Randomization to Months 12 and 18
TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Randomization to Months 12 and 18
Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time - Intent to Treat Population
Časové okno: Randomization to Month 24
TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Randomization to Month 24
Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18
Časové okno: Baseline to Month 18
TP=treatment period; WP=withdrawal period. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)
Baseline to Month 18
Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18
Časové okno: Randomization to Month 18
TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity.
Randomization to Month 18
Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time
Časové okno: Randomization to Month 18
TP=treatment period; WP=withdrawal period. The SDAI is the simple linear sum of 5 outcome parameters: swollen joint count (SJC) and tender joint count (TJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SJC is assessed and recorded at each visit, with no swelling=0, swelling=1 (higher score indicates greater swelling). TJC is assessed at each visit through identification of joints that are painful under pressure or to passive motion, with no tenderness=0, tenderness=1 (higher score indicates greater affection due to disease activity)..
Randomization to Month 18
Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time
Časové okno: Randomization to Month 24
HAQ response defined as a reduction of at least 0.3 units from baseline in score on the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.
Randomization to Month 24
Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Over Time
Časové okno: Randomization to Month 18
The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.
Randomization to Month 18
Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores of Short Form-36 (SF-36)
Časové okno: Randomization to Months 6, 12, and 18
TP=treatment period; WP=withdrawal period. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
Randomization to Months 6, 12, and 18
Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)
Časové okno: Randomization to Month 18
TP=treatment period; WP=withdrawal period. Change from Baseline=Postbaseline-baseline value. MRI was used to assess joint damage progression at Months 6, 12, and 18. If >20% of joints with a missing score for a parameter (erosion, osteitis, and synovitis), the MRI score of each parameter was considered missing. If ≤20% of joints had a missing score for a parameter, the MRI score for that parameter from the missing joints was carried forward from the previous MRI assessment, or carried backward from the next MRI assessment, if missing score occurred at baseline. MRI total score ranged from 0 (best outcome) to 4 (worst outcome). A gadolinium-enhanced MRI of the dominant hand-wrist was performed on all randomized patients at 5 points. The hand/wrist assessed to have more synovitis was selected initially and used for all subsequent evaluations. The MRI examination was standardized to ensure sufficient image quality for the evaluation of radiographic progression of rheumatoid arthritis.
Randomization to Month 18
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period
Časové okno: Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period
Adverse Events (AEs) of Interest During the Treatment Period
Časové okno: Day 1 to 56 days following last dosing day (Day 365)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. AEs of special interest are events potentially associated with the drug or disease under study.
Day 1 to 56 days following last dosing day (Day 365)
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality During Treatment Period
Časové okno: Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)
Lower limit of normal (LLN); Upper limit of normal (ULN); Pretreatment (preRX). Criteria for marked abnormality: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.
Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)
Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time During Withdrawal Period- Treated Participants in Remission at Month 12
Časové okno: End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)
WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.). Percentage= number of participants with remission divided by number of participants who were analyzed (all treated participants who were in remission at end of treatment period and entered the Withdrawal Period)
End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)
Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) Over Time in Treatment Period and Withdrawal Period
Časové okno: Randomization to Month 24
TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity. Percent=number with remission/number evaluated (ITT)
Randomization to Month 24
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) and Discontinuations Due to AEs During the Full Study (All Periods)
Časové okno: Day 1 to 56 days post last dose in the study, up to Month 30
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Includes data up to last active dose date +56 days if the participant discontinued the Treatment Period or did not enter the Withdrawal Period, up to the day of discontinuation in the Withdrawal Period for participants discontinuing the Withdrawal Period without entering the Re-exposure Period (RP), up to Day 729 visit (Month 24) for participants who complete the Withdrawal Period, and up to 56 days post last active dose in Re-exposure Period for participants entering the Re-exposure Period.
Day 1 to 56 days post last dose in the study, up to Month 30
Adverse Events (AEs) of Interest During the Withdrawal Period
Časové okno: Last dose in TP + 57 days, up to Month 24
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes events with an onset date on or after 57 days post last dosing day (active abatacept or active MTX whichever is the later) in the Treatment Period and up to end of Withdrawal Period. Treatment groups represent treatment received during the Treatment Period.
Last dose in TP + 57 days, up to Month 24
Adverse Events (AEs) of Interest During the Re-exposure Period
Časové okno: First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.
First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Withdrawal Period
Časové okno: Last dose in TP + 57 days, up to Month 24
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase (GGT) (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.
Last dose in TP + 57 days, up to Month 24
Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Re-exposure Period
Časové okno: Start of re-exposure period to 56 days post last dose, up to Month 30
LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.
Start of re-exposure period to 56 days post last dose, up to Month 30

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Bristol-Myers Squibb

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. prosince 2010

Primární dokončení (Aktuální)

1. září 2013

Dokončení studie (Aktuální)

1. října 2014

Termíny zápisu do studia

První předloženo

3. června 2010

První předloženo, které splnilo kritéria kontroly kvality

10. června 2010

První zveřejněno (Odhad)

11. června 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

14. ledna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. prosince 2015

Naposledy ověřeno

1. prosince 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IM101-226
  • 2010-018674-20 (Číslo EudraCT)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Abatacept

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Belarus

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
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