- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01076205
Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis (AGIL)
Long Term Documentation of the Safety and Efficacy as Well as the Effects on Quality of Life and Work Productivity in Patients With Rheumatoid Arthritis Under HUMIRA® (Adalimumab) in Routine Clinical Practice (AGIL)
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs
- Inclusive methotrexate
- Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before; In case of incompatibility with methotrexate, Humira can be used as monotherapy.
Exclusion Criteria:
- Hypersensitivity against the drug or one of the other ingredients
- Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
- Moderate to severe cardiac insufficiency
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Pouze případ
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
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Adalimumab
Adults with moderate to severe active rheumatoid arthritis (RA) who initiated adalimumab therapy during routine clinical care.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months
Časové okno: Baseline and 6, 12, 24, 36, 48, and 60 months
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Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline.
Sick leave days were based on patient recall.
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Baseline and 6, 12, 24, 36, 48, and 60 months
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Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months
Časové okno: Baseline, 6, 12, 24, 36, 48, and 60 months
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Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline.
Sick leave days were based on patient recall.
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Baseline, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Work Productivity and Activity Impairment: Absenteeism
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
|
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Work Productivity and Activity Impairment: Presenteeism
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
|
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
|
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
|
The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. |
Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Work Activity Index (WAI)
Časové okno: Baseline and 6, 12, 24, 36, 48, and 60 months
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The WAI is a tool designed to record the work ability of employees and consists of 7 questions.
The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI.
Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment.
Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best).
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Baseline and 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Disease Activity Score - 28 Joints (DAS28)
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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The DAS28 is a validated index of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score.
Scores on the DAS28 range from 0 to 10.
A DAS28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission.
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Tender Joint Count
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Swollen Joint Count
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Erythrocyte Sedimentation Rate
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in C-reactive Protein
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI)
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene.
Patients are asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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EuroQol-5 Dimensions (EQ-5D) Scores
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):
For each dimension the patient is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). |
Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Change From Baseline in Euroqol Visual Analog Scale (VAS)
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life.
The patient questionnaire consists of two parts.
The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health.
Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine."
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of Physician Visits in Past 6 Months
Časové okno: Baseline, 6, 12, 24, 36, 48, and 60 months
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Participants self-reported the number of physician visits they had in the past 6 months.
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Baseline, 6, 12, 24, 36, 48, and 60 months
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Number of Inpatient Hospitalizations in Past 6 Months
Časové okno: Baseline, 6, 12, 24, 36, 48, and 60 months
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Participants self-reported the number of hospitalizations they had in the past 6 months.
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Baseline, 6, 12, 24, 36, 48, and 60 months
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Duration of Inpatient Hospitalizations in Past 6 Months
Časové okno: Baseline, 6, 12, 24, 36, 48, and 60 months
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Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.
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Baseline, 6, 12, 24, 36, 48, and 60 months
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Number of Days With Impairment of Non-Occupational Activities in Past 6 Months
Časové okno: Baseline, 6, 12, 24, 36, 48, and 60 months
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Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time).
Participants with no impairment were considered to have 0 days.
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Baseline, 6, 12, 24, 36, 48, and 60 months
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Duration of Morning Stiffness
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Participant's Assessment of Pain
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain).
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Participant's Assessment of Fatigue
Časové okno: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly).
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Baseline and 3, 6, 12, 24, 36, 48, and 60 months
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Percentage of Participants Taking Concomitant RA Medications
Časové okno: Baseline to month 60
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Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others.
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Baseline to month 60
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Patient Assessment of Adalimumab Therapy
Časové okno: Months 3, 6, 12, 24, 36, 48, and 60
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Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:
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Months 3, 6, 12, 24, 36, 48, and 60
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Henning Kleine, PhD, AbbVie Deutschland GmbH & Co. KG, Medical Department
Publikace a užitečné odkazy
Obecné publikace
- Behrens F, Tony HP, Koehm M, Schwaneck EC, Gnann H, Greger G, Burkhardt H, Schmalzing M. Sustained improvement in work outcomes in employed patients with rheumatoid arthritis during 2 years of adalimumab therapy: an observational cohort study. Clin Rheumatol. 2020 Sep;39(9):2583-2592. doi: 10.1007/s10067-020-05038-y. Epub 2020 Mar 23. Erratum In: Clin Rheumatol. 2020 May 30;:
- Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Gnann H, Greger G, Tony HP, Burkhardt H. Use of a "critical difference" statistical criterion improves the predictive utility of the Health Assessment Questionnaire-Disability Index score in patients with rheumatoid arthritis. BMC Rheumatol. 2019 Dec 10;3:51. doi: 10.1186/s41927-019-0095-2. eCollection 2019.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P11-973
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