Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— AGIL  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076205
• Other study ID #: P11-973
• Status: Completed
• Start date: January 12, 2009
• Est. completion date: September 14, 2017

Study information

• Verified date: August 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in Germany, with a focus on the impact of therapy on employment-related outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7229
• Est. completion date: September 14, 2017
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months	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.	Baseline and 6, 12, 24, 36, 48, and 60 months
Primary	Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Primary	Change From Baseline in Work Productivity and Activity Impairment: Absenteeism	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
Primary	Change From Baseline in Work Productivity and Activity Impairment: Presenteeism	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
Primary	Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment	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
Primary	Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment	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
Primary	Change From Baseline in Work Activity Index (WAI)	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).	Baseline and 6, 12, 24, 36, 48, and 60 months
Primary	Change From Baseline in Disease Activity Score - 28 Joints (DAS28)	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.	Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Primary	Change From Baseline in Tender Joint Count	Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.	Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Primary	Change From Baseline in Swollen Joint Count	Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.	Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Primary	Change From Baseline in Erythrocyte Sedimentation Rate		Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Primary	Change From Baseline in C-reactive Protein		Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Primary	Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI)	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.	Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Primary	EuroQol-5 Dimensions (EQ-5D) Scores	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): agility/mobility; self-care; usual activities; pain, bodily discomfort; anxiety, depression; 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
Primary	Change From Baseline in Euroqol Visual Analog Scale (VAS)	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."	Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Secondary	Number of Physician Visits in Past 6 Months	Participants self-reported the number of physician visits they had in the past 6 months.	Baseline, 6, 12, 24, 36, 48, and 60 months
Secondary	Number of Inpatient Hospitalizations in Past 6 Months	Participants self-reported the number of hospitalizations they had in the past 6 months.	Baseline, 6, 12, 24, 36, 48, and 60 months
Secondary	Duration of Inpatient Hospitalizations in Past 6 Months	Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.	Baseline, 6, 12, 24, 36, 48, and 60 months
Secondary	Number of Days With Impairment of Non-Occupational Activities in Past 6 Months	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.	Baseline, 6, 12, 24, 36, 48, and 60 months
Secondary	Duration of Morning Stiffness		Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Secondary	Participant's Assessment of Pain	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).	Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Secondary	Participant's Assessment of Fatigue	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).	Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Secondary	Percentage of Participants Taking Concomitant RA Medications	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.	Baseline to month 60
Secondary	Patient Assessment of Adalimumab Therapy	Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options: Considerably better; Better; About the same; Worse; Noticeably worse	Months 3, 6, 12, 24, 36, 48, and 60

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