N/A
Completed N=7,229
Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01076205 ↗Enrolled (actual)
7,229
Serious AEs
12.9%
Results posted
Feb 2019
Primary outcomePrimary: Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months — -4.3; -3.4; -5.6; -6.7 days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months |
-4.3; -3.4; -5.6; -6.7; -6.4; -4.1 | — |
| PRIMARY Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months |
44.7; 29.5; 28.5; 27.9; 26.2; 24.1 | — |
| PRIMARY Change From Baseline in Work Productivity and Activity Impairment: Absenteeism |
-7.9; -8.0; -7.3; -6.5; -8.0; -5.2 | — |
| PRIMARY Change From Baseline in Work Productivity and Activity Impairment: Presenteeism |
-11.3; -11.8; -12.7; -12.9; -15.3; -16.4 | — |
| PRIMARY Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment |
-13.0; -14.4; -16.4; -15.3; -18.8; -16.7 | — |
| PRIMARY Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment |
-11.9; -12.8; -13.8; -14.3; -15.4; -14.8 | — |
| PRIMARY Change From Baseline in Work Activity Index (WAI) |
2.5; 3.0; 3.2; 3.6; 3.3; 3.0 | — |
| PRIMARY Change From Baseline in Disease Activity Score - 28 Joints (DAS28) |
-1.34; -1.56; -1.71; -1.84; -1.94; -2.01 | — |
| PRIMARY Change From Baseline in Tender Joint Count |
-4.3; -4.9; -5.3; -5.6; -5.9; -6.1 | — |
| PRIMARY Change From Baseline in Swollen Joint Count |
-3.2; -3.8; -4.1; -4.4; -4.8; -5.0 | — |
| PRIMARY Change From Baseline in Erythrocyte Sedimentation Rate |
-7.1; -7.9; -8.5; -9.0; -8.9; -9.3 | — |
| PRIMARY Change From Baseline in C-reactive Protein |
-7.1; -7.3; -7.5; -8.0; -8.6; -5.8 | — |
| PRIMARY Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) |
-0.22; -0.24; -0.27; -0.28; -0.30; -0.32 | — |
| PRIMARY EuroQol-5 Dimensions (EQ-5D) Scores |
1662; 2072; 1937; 1644; 1190; 843 | — |
| PRIMARY Change From Baseline in Euroqol Visual Analog Scale (VAS) |
10.0; 11.7; 12.9; 14.9; 16.2; 15.8 | — |
| SECONDARY Number of Physician Visits in Past 6 Months |
3.3; 2.5; 2.2; 1.9; 1.8; 1.9 | — |
| SECONDARY Number of Inpatient Hospitalizations in Past 6 Months |
0.4; 0.2; 0.2; 0.1; 0.1; 0.1 | — |
| SECONDARY Duration of Inpatient Hospitalizations in Past 6 Months |
2.3; 1.1; 1.1; 0.8; 0.7; 0.7 | — |
| SECONDARY Number of Days With Impairment of Non-Occupational Activities in Past 6 Months |
56.9; 27.7; 22.4; 20.6; 18.2; 19.2 | — |
| SECONDARY Duration of Morning Stiffness |
65.3; 34.6; 27.4; 24.2; 20.9; 19.0 | — |
| SECONDARY Participant's Assessment of Pain |
6.1; 4.4; 4.2; 3.9; 3.7; 3.5 | — |
| SECONDARY Participant's Assessment of Fatigue |
5.8; 4.4; 4.2; 4.0; 3.8; 3.5 | — |
| SECONDARY Percentage of Participants Taking Concomitant RA Medications |
53.4; 58.6; 12.0; 13.0; 3.6; 4.1 | — |
| SECONDARY Patient Assessment of Adalimumab Therapy |
35.6; 39.6; 46.3; 51.6; 51.5; 55.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01076205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.