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

NCT01076205 | Completed Results

• 1 other identifier: P11-973
• Study Type: observational
• Target: 7,229
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Work Productivity; Long-term Observation; Humira; Quality of Life; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change From Baseline in Erythrocyte Sedimentation Rate

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

• Change From Baseline in C-reactive Protein

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

• 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

• 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

• 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 Outcomes (9)

• Number of Physician Visits in Past 6 Months

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

• Number of Inpatient Hospitalizations in Past 6 Months

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

• Duration of Inpatient Hospitalizations in Past 6 Months

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

• Number of Days With Impairment of Non-Occupational Activities in Past 6 Months

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

• Duration of Morning Stiffness

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

Study Arms (1)

Adalimumab

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample: Patients with rheumatoid arthritis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (2)

• 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.

  PMID: 32206973 DERIVED

• 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.

  PMID: 31867564 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor Abbott)

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Henning Kleine, PhD

  AbbVie Deutschland GmbH & Co. KG, Medical Department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: January 12, 2009
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: February 7, 2019
• Results First Posted: February 7, 2019

Record last verified: 2018-08