An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.

The safety population, including all patients that received at least one dose of the study drug.

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health 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.

Safety population; "n" indicates the number of participants with available data at each time point.

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.

A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.

A Moderate EULAR Response is defined as either:

• an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or
• an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.

No Response is defined as either:

• an improvement (decrease) in the DAS28 of ≤ to 0.6, or
• an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1.

Safety population;

American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 20% improvement in tender joint count;

• ≥ 20% improvement in swollen joint count; and

• ≥ 20% improvement in at least 3 of the 5 following parameters:

  • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
  • Patient's global assessment of disease activity (measured on a 100 mm VAS);
  • Physician's global assessment of disease activity (measured on a 100 mm VAS);
  • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
  • Acute phase reactant value (C-reactive protein [CRP]).

Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR20 could be calculated at each time point.

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 50% improvement in tender joint count;

• ≥ 50% improvement in swollen joint count; and

• ≥ 50% improvement in at least 3 of the 5 following parameters:

  • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
  • Patient's global assessment of disease activity (measured on a 100 mm VAS);
  • Physician's global assessment of disease activity (measured on a 100 mm VAS);
  • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
  • Acute phase reactant value (C-reactive protein [CRP]).

Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR50 could be calculated at each time point.

American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 70% improvement in tender joint count;

• ≥ 70% improvement in swollen joint count; and

• ≥ 70% improvement in at least 3 of the 5 following parameters:

  • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
  • Patient's global assessment of disease activity (measured on a 100 mm VAS);
  • Physician's global assessment of disease activity (measured on a 100 mm VAS);
  • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
  • Acute phase reactant value (C-reactive protein [CRP]).

Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. "n" indicates the number of patients for whom ACR70 could be calculated at each time point.

Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.

Safety population; "n" indicates the number of participants with available data at each time point.