Clinical trial NCT01076205: Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Work Productivity
Long-term Observation
Humira
Quality of Life
Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 7229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample: Patients with rheumatoid arthritis

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months
timeFrame: Baseline and 6, 12, 24, 36, 48, and 60 months
measure: Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months
timeFrame: Baseline, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Work Productivity and Activity Impairment: Absenteeism
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Work Productivity and Activity Impairment: Presenteeism
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Work Activity Index (WAI)
timeFrame: Baseline and 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Disease Activity Score - 28 Joints (DAS28)
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Tender Joint Count
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Swollen Joint Count
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Erythrocyte Sedimentation Rate
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in C-reactive Protein
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: EuroQol-5 Dimensions (EQ-5D) Scores
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Change From Baseline in Euroqol Visual Analog Scale (VAS)
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
Secondary outcomes:
measure: Number of Physician Visits in Past 6 Months
timeFrame: Baseline, 6, 12, 24, 36, 48, and 60 months
measure: Number of Inpatient Hospitalizations in Past 6 Months
timeFrame: Baseline, 6, 12, 24, 36, 48, and 60 months
measure: Duration of Inpatient Hospitalizations in Past 6 Months
timeFrame: Baseline, 6, 12, 24, 36, 48, and 60 months
measure: Number of Days With Impairment of Non-Occupational Activities in Past 6 Months
timeFrame: Baseline, 6, 12, 24, 36, 48, and 60 months
measure: Duration of Morning Stiffness
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Participant's Assessment of Pain
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Participant's Assessment of Fatigue
timeFrame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months
measure: Percentage of Participants Taking Concomitant RA Medications
timeFrame: Baseline to month 60
measure: Patient Assessment of Adalimumab Therapy
timeFrame: Months 3, 6, 12, 24, 36, 48, and 60
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Deutschland GmbH & Co. KG, Medical Department
name: Henning Kleine, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.