Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice

Study Overview
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Brief Summary
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Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.

Detailed Description
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Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the 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.

Official Title
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Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate. Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. In case of incompatibility with methotrexate, adalimumab 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid arthritis<br>Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Disease Activity Score (DAS) 28 | 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 general health (measured on a visual analog scale [VAS] from 0 to 10 cm) 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 Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| Percentage of Participants in DAS28 Remission | Clinical remission is defined as a DAS28 score of < 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. | Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| Percentage of Participants With Low, Moderate and High 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. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| Participants Assessment of Pain Over Time | Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| Participants Assessment of Fatigue Over Time | Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status. | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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. | Baseline and Months 6, 18, 24, and 30 | 
| 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 due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months. | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 | 
| 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. | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 | 
| Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication |  | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Rheumatoid Arthritis, Effectiveness