Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.
Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.
Study Type
OBSERVATIONAL
Enrollment
4,208
Change From Baseline in Disease Activity Score (DAS) 28
The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. 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.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Percentage of Participants in DAS28 Remission
Clinical remission is defined as a disease activity score (DAS) 28 score of \< 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Time frame: Months 3, 6, 9, 12, 18, and 24
Percentage of Participants With a Significant Therapeutic Response
Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
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Site Reference ID/Investigator# 35036
Aachen, Germany
Site Reference ID/Investigator# 35510
Ahlen, Germany
Site Reference ID/Investigator# 35040
Ahrensburg, Germany
Site Reference ID/Investigator# 35043
Altenburg, Germany
Site Reference ID/Investigator# 35046
Altenholz, Germany
Site Reference ID/Investigator# 35049
Amberg, Germany
Site Reference ID/Investigator# 35057
Arnstadt, Germany
Site Reference ID/Investigator# 35520
Attendorn, Germany
Site Reference ID/Investigator# 33349
Augsburg, Germany
Site Reference ID/Investigator# 33358
Bad Abbach, Germany
...and 293 more locations
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Percentage of Participants With Low, Moderate and High Disease Activity
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 \>3.2 to ≤5.1; High disease activity as a DAS28 \>5.1.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Erythrocyte Sedimentation Rate (ESR) Over Time
Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
C-Reactive Protein (CRP) Levels Over Time
C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Tender Joint Count (TJC) Over Time
Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Swollen Joint Count (SJC) Over Time
Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Hannover Functional Questionnaire (FFbH) Over Time
A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Patients Global Assessment of Disease Activity Over Time
Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time frame: Baseline and Months 3, 6, 9, 12, 18 and 24
Participants Assessment of Fatigue Over Time
Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time frame: Baseline and Month 3, 6, 9, 12, 18, and 24
Participants Assessment of Pain Over Time
Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24
Percentage of Participants With Impairment in Daily Activities
Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.
Time frame: Baseline and Months 3, 6, 9, 18, and 24
Number of Days Missed From Work Due to Rheumatoid Arthritis
Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.
Time frame: Baseline and Months 6, 12, 18, and 24
Percentage of Participants With In-patient Hospitalization
The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.
Time frame: Month 6, 12, 18, and 24
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Time frame: Baseline and Months 3, 6, 9, 12, 18, and 24