A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
5 de octubre de 2016 actualizado por: Hoffmann-La Roche
A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
This multicenter, open-label, single arm, interventional, long-term extension (LTE) study will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE study (NCT01194414) (EudraCT Number 2010-018375-22).
Participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2 points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever occurs first.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
11
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bordeaux, Francia, 33076
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Montpellier, Francia, 34295
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Nantes, Francia, 44035
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Paris, Francia, 75679
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Strasbourg, Francia, 67098
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Toulouse, Francia, 31059
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Negative pregnancy test at screening and baseline
- Participants who have completed the 97-week WA22762 LTE study on SC or intravenous (IV) TCZ and who experienced, at any time during WA22762, clinically significant improvement in DAS28 (>1.2 points), and based on the investigator's judgment may continue to benefit from TCZ treatment in this study investigating the SC formulation
- No current or recent adverse events or laboratory findings preventing the use of the study drug dose of TCZ 162 mg SC at baseline visit
- Receiving treatment on an outpatient basis
- Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception during the study and for at least 3 months following the last dose of study drug
- Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the recommended dose are permitted if on stable dose regimen for greater than and equal to (>/=) 4 weeks prior to baseline
- Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
Exclusion Criteria:
- Participants who have prematurely withdrawn from the WA22762 LTE study for any reason
- Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell co stimulation modulator since the last administration of study drug in the WA22762 LTE study
- Immunization with a live/attenuated vaccine since the last administration of study drug in the WA22762 LTE study
- Diagnosis, since last WA22762 visit (Week 97), of rheumatic autoimmune disease other than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted
- Diagnosis, since last WA22762 visit (Week 97), of inflammatory joint disease other than RA
- Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
- Evidence of serious uncontrolled concomitant disease
- Known active current or history of recurrent infection
- Primary or secondary immunodeficiency (history of or currently active)
- Body weight >150 kilograms (kg)
- Pregnant or lactating women
- Inadequate hematologic, renal or liver function
- History of alcohol, drug or chemical abuse within 1 year prior to screening
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Tocilizumab
Moderate to severe rheumatoid arthritis participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in DAS28 of >1.2 points) will continue tocilizumab treatment within this local LTE study for a maximum of 156 weeks, or until SC TCZ becomes commercially available, whichever occurs first.
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Participants will receive TCZ 162 milligrams (mg) SC injection once a week.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline up to approximately 142 weeks
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An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment.
An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect.
AEs included SAEs as well as non-serious AEs.
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Baseline up to approximately 142 weeks
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Percentage of Participants With AEs and SAEs Related to TCZ
Periodo de tiempo: Baseline up to approximately 142 weeks
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An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs included SAEs as well as non-serious AEs.
Causality of AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs).
AEs with causality of certain, probable/likely, and possible were considered TCZ related.
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Baseline up to approximately 142 weeks
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Percentage of Participants With Adverse Events of Special Interest (AESIs)
Periodo de tiempo: Baseline up to approximately 142 weeks
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Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.
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Baseline up to approximately 142 weeks
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Percentage of Participants With AESIs Related to TCZ
Periodo de tiempo: Baseline up to approximately 142 weeks
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AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.
Percentage of participants with AESI related to the drug were presented.
Causality of AESIs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs).
AESIs with causality of certain, probable/likely, and possible were considered TCZ related.
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Baseline up to approximately 142 weeks
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Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification
Periodo de tiempo: Baseline up to approximately 142 weeks
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An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.
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Baseline up to approximately 142 weeks
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Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities
Periodo de tiempo: Baseline up to approximately 142 weeks
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Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (<) 40 beats per minute and value greater than (>) 150 beats per minute, systolic blood pressure (SBP) of < 80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or > 40 degrees Celsius, respiratory rate of <10 or > 50 breaths/minute and criteria for PCI change in physical examination: >/=10% increase or decrease of body weight in kilograms (kg).
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Baseline up to approximately 142 weeks
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Percentage of Participants With Clinically Significant Laboratory Abnormalities
Periodo de tiempo: Baseline up to approximately 142 weeks
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Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper
limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN);
neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN);
eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN);
creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN);
uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN);
urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field.
Overall percentage of participants with any clinically significant laboratory abnormality was reported.
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Baseline up to approximately 142 weeks
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Percentage of Participants With Anti-TCZ Antibodies
Periodo de tiempo: Baseline up to approximately 142 weeks
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Baseline up to approximately 142 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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The DAS 28 ESR score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]).
DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity.
A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in Simplified Disease Activity Index (SDAI) Score
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]).
VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity.
SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in TJC
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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For TJC a total of 28 joints were assessed.
The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints).
Lower scores indicate no tender joint and higher scores indicate worsening tender joints.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in SJC
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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For SJC, a total of 28 joints were assessed.
The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints).
Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Percentage of Participants With Clinical Remission
Periodo de tiempo: Week 48, 108
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Clinical remission defined as:DAS28-ESR score < 2.6 and/or SDAI score </= 3.3.DAS28 score is measure of subject's disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr).
DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity.
DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity.
SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)].
VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity.
SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.
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Week 48, 108
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Percentage of Participants With Concomitant Corticosteroid Discontinuation
Periodo de tiempo: Baseline up to approximately 142 weeks
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Baseline up to approximately 142 weeks
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Percentage of Participants With Concomitant Corticosteroid Dose Reduction
Periodo de tiempo: Baseline up to approximately 142 weeks
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Baseline up to approximately 142 weeks
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Time to Concomitant Corticosteroid Discontinuation
Periodo de tiempo: Baseline up to approximately 142 weeks
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Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.
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Baseline up to approximately 142 weeks
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Time to Concomitant Corticosteroid Dose Reduction
Periodo de tiempo: Baseline up to approximately 142 weeks
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Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.
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Baseline up to approximately 142 weeks
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Change From Baseline in PtGA of Disease Activity
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in Patient's Assessment of Pain
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life.
It measures the participant's ability to perform everyday tasks.
The index consists of 20 questions regarding the function of the upper and lower extremities.
These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week.
Each question is evaluated according to the degree of severity on a 4-point scale.
Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in Physician's Global Assessment of Disease Activity
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS.
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".
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in ESR
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 millimeters per hour (mm/hr).
A decrease in the level indicates reduction in inflammation and therefore improvement.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Change From Baseline in CRP
Periodo de tiempo: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation.
Completer last visit: Last visit data for participants who completed the study.
Last visit: Last visit data for all participants (including those who discontinued prematurely).
Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.
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Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2012
Finalización primaria (Actual)
1 de septiembre de 2015
Finalización del estudio (Actual)
1 de septiembre de 2015
Fechas de registro del estudio
Enviado por primera vez
19 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
27 de noviembre de 2012
Publicado por primera vez (Estimar)
28 de noviembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
5 de octubre de 2016
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ML28544
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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