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

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ClinicalTrials.gov Identifier: NCT01076205
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief 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.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 7229 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Actual Study Start Date : January 12, 2009
Actual Primary Completion Date : September 14, 2017
Actual Study Completion Date : September 14, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Adalimumab
Adults with moderate to severe active rheumatoid arthritis (RA) who initiated adalimumab therapy during routine clinical care.



Primary Outcome Measures :
  1. Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months [ Time Frame: Baseline and 6, 12, 24, 36, 48, and 60 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.

  2. Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 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.

  3. Change From Baseline in Work Productivity and Activity Impairment: Absenteeism [ Time Frame: 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.


  4. Change From Baseline in Work Productivity and Activity Impairment: Presenteeism [ Time Frame: 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.


  5. Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment [ Time Frame: 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.


  6. Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment [ Time Frame: 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.


  7. Change From Baseline in Work Activity Index (WAI) [ Time Frame: Baseline and 6, 12, 24, 36, 48, and 60 months ]
    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).

  8. Change From Baseline in Disease Activity Score - 28 Joints (DAS28) [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
    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.

  9. Change From Baseline in Tender Joint Count [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
    Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

  10. Change From Baseline in Swollen Joint Count [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
    Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

  11. Change From Baseline in Erythrocyte Sedimentation Rate [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
  12. Change From Baseline in C-reactive Protein [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
  13. Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
    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.

  14. EuroQol-5 Dimensions (EQ-5D) Scores [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]

    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).


  15. Change From Baseline in Euroqol Visual Analog Scale (VAS) [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
    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."


Secondary Outcome Measures :
  1. Number of Physician Visits in Past 6 Months [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Participants self-reported the number of physician visits they had in the past 6 months.

  2. Number of Inpatient Hospitalizations in Past 6 Months [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Participants self-reported the number of hospitalizations they had in the past 6 months.

  3. Duration of Inpatient Hospitalizations in Past 6 Months [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 months ]
    Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.

  4. Number of Days With Impairment of Non-Occupational Activities in Past 6 Months [ Time Frame: Baseline, 6, 12, 24, 36, 48, and 60 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.

  5. Duration of Morning Stiffness [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
  6. Participant's Assessment of Pain [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
    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).

  7. Participant's Assessment of Fatigue [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months ]
    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).

  8. Percentage of Participants Taking Concomitant RA Medications [ Time Frame: Baseline to month 60 ]
    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.

  9. Patient Assessment of Adalimumab Therapy [ Time Frame: Months 3, 6, 12, 24, 36, 48, and 60 ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample: Patients with rheumatoid arthritis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076205


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Henning Kleine, PhD AbbVie Deutschland GmbH & Co. KG, Medical Department
  Study Documents (Full-Text)

Documents provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Study Protocol: amendment  [PDF] March 6, 2012

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01076205    
Other Study ID Numbers: P11-973
First Posted: February 26, 2010    Key Record Dates
Results First Posted: February 7, 2019
Last Update Posted: February 7, 2019
Last Verified: August 2018
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Work Productivity
Long-term Observation
Humira
Quality of Life
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases