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Rheumatoid ArthritisAGILNCT01076205

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

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Rheumatoid Arthritis
How many people
7,229 participants
Where
No sites listed yet
Study dates
12 Jan 2009to 14 Sep 2017
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Community sample: Patients with rheumatoid arthritis

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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)

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.

Keywords
Work Productivity, Long-term Observation, Humira, Quality of Life, Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01076205
Study groupRoleWhat they receive
AdalimumabAdults with moderate to severe active rheumatoid arthritis (RA) who initiated adalimumab therapy during routine clinical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6, 12, 24, 36, 48, and 60 months

  2. 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.

    Measured: Baseline, 6, 12, 24, 36, 48, and 60 months

  3. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  4. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  5. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  6. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  7. 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).

    Measured: Baseline and 6, 12, 24, 36, 48, and 60 months

  8. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  9. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  10. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  11. Change From Baseline in Erythrocyte Sedimentation Rate

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  12. Change From Baseline in C-reactive Protein

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  13. 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.

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  14. 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).

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  15. 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."

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Secondary outcomes (9)

  1. Number of Physician Visits in Past 6 Months

    Participants self-reported the number of physician visits they had in the past 6 months.

    Measured: Baseline, 6, 12, 24, 36, 48, and 60 months

  2. Number of Inpatient Hospitalizations in Past 6 Months

    Participants self-reported the number of hospitalizations they had in the past 6 months.

    Measured: Baseline, 6, 12, 24, 36, 48, and 60 months

  3. 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.

    Measured: Baseline, 6, 12, 24, 36, 48, and 60 months

  4. 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.

    Measured: Baseline, 6, 12, 24, 36, 48, and 60 months

  5. Duration of Morning Stiffness

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  6. 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).

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  7. 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).

    Measured: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

  8. 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.

    Measured: Baseline to month 60

  9. 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

    Measured: Months 3, 6, 12, 24, 36, 48, and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study start12 Jan 2009
  3. Primary completion14 Sep 2017
  4. Study completion14 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
7,229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076205
Sponsor's protocol ID
P11-973
Acronym
AGIL
Status last verified
Aug 2018
First submitted
24 Feb 2010
Last updated
7 Feb 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 32206973

  • 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.

    PubMed 31867564

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01076205, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.

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