Rheumatoid Arthritis
Conditions
Keywords
Safety, Rheumatoid Arthritis, Effectiveness
Brief summary
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
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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score (DAS) 28 | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Percentage of Participants in DAS28 Remission | Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythrocyte Sedimentation Rate (ESR) Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. |
| C-Reactive Protein (CRP) Levels Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Tender Joint Count (TJC) Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. |
| Swollen Joint Count (SJC) Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. |
| Hannover Functional Questionnaire (FFbH) Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Patients Global Assessment of Disease Activity Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Percentage of Participants With a Significant Therapeutic Response | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Participants Assessment of Fatigue Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Percentage of Participants With Impairment in Daily Activities | Baseline and Months 6, 18, 24, and 30 | Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks. |
| Number of Days Missed From Work Due to Rheumatoid Arthritis | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Percentage of Participants With In-patient Hospitalization | Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| 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 | — |
| Participants Assessment of Pain Over Time | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
| Percentage of Participants With Low, Moderate and High Disease Activity | Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60 | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years. | 5,745 |
| Total | 5,745 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ADR and lack of efficacy | 61 |
| Overall Study | Adverse drug reaction (ADR) | 453 |
| Overall Study | Lack of Efficacy | 1,193 |
| Overall Study | Lost to Follow-up | 2,363 |
| Overall Study | Other | 523 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 12.8 |
| Gender Female | 4428 participants |
| Gender Male | 1315 participants |
| Region of Enrollment Germany | 5745 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 5,745 |
| serious Total, serious adverse events | 163 / 5,745 |
Outcome results
Primary
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.
Time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 3 (n=3918) | -1.6 units on a scale | Standard Deviation 1.3 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 6 (n=3347) | -1.8 units on a scale | Standard Deviation 1.4 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 12 (n=2872) | -2.0 units on a scale | Standard Deviation 1.4 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 18 (n=2397) | -2.1 units on a scale | Standard Deviation 1.4 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 24 (n=2099) | -2.2 units on a scale | Standard Deviation 1.4 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 30 (n=1810) | -2.3 units on a scale | Standard Deviation 1.5 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 36 (n=1564) | -2.3 units on a scale | Standard Deviation 1.5 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 48 (n=1261) | -2.3 units on a scale | Standard Deviation 1.5 |
| Rheumatoid Arthritis | Change From Baseline in Disease Activity Score (DAS) 28 | Month 60 (n=934) | -2.4 units on a scale | Standard Deviation 1.5 |
Primary
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.
Time frame: Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 3 (n=3918) | 12.8 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 6 (n=3347) | 16.9 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 12 (n=2872) | 19.4 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 18 (n=2397) | 23.0 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 24 (n=2099) | 23.3 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 30 (n=1810) | 24.3 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 36 (n=1564) | 24.0 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 48 (n=1261) | 24.7 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants in DAS28 Remission | Month 60 (n=934) | 25.6 percentage of participants |
Secondary
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, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 0 (n=3852) | 33.7 mg/L | Standard Deviation 63.8 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 3 (n=3209) | 19.8 mg/L | Standard Deviation 56.3 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 6 (n=2671) | 16.1 mg/L | Standard Deviation 29.9 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 12 (n=2192) | 17.0 mg/L | Standard Deviation 89.8 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 18 (n=1770) | 14.9 mg/L | Standard Deviation 68 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 24 (n=1573) | 12.3 mg/L | Standard Deviation 27.3 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 30 (n=1355) | 12.0 mg/L | Standard Deviation 26.4 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 36 (n=1211) | 11.0 mg/L | Standard Deviation 22.8 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 48 (n=1000) | 11.6 mg/L | Standard Deviation 27.8 |
| Rheumatoid Arthritis | C-Reactive Protein (CRP) Levels Over Time | Month 60 (n=756) | 9.2 mg/L | Standard Deviation 16.7 |
Secondary
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, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 36 (n=1685) | 20.9 mm/hour | Standard Deviation 17.5 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 0 (n=4400) | 34.5 mm/hour | Standard Deviation 23.1 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 3 (n=4083) | 24.7 mm/hour | Standard Deviation 20.4 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 6 (n=3467) | 23.8 mm/hour | Standard Deviation 19.9 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 12 (n=2966) | 22.8 mm/hour | Standard Deviation 18.9 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 18 (n=2472) | 22.0 mm/hour | Standard Deviation 18.4 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 24 (n=2156) | 21.6 mm/hour | Standard Deviation 17.7 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 30 (n=1860) | 21.4 mm/hour | Standard Deviation 18.1 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 48 (n=1341) | 21.5 mm/hour | Standard Deviation 17.8 |
| Rheumatoid Arthritis | Erythrocyte Sedimentation Rate (ESR) Over Time | Month 60 (n=998) | 21.2 mm/hour | Standard Deviation 17.6 |
Secondary
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, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 0 (n=4360) | 57.7 units on a scale | Standard Deviation 23.2 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 3 (n=4075) | 65.1 units on a scale | Standard Deviation 23.4 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 6 (n=3498) | 67.1 units on a scale | Standard Deviation 23.7 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 12 (n=2978) | 68.3 units on a scale | Standard Deviation 23.6 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 18 (n=2493) | 69.4 units on a scale | Standard Deviation 23.4 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 24 (n=2194) | 69.9 units on a scale | Standard Deviation 23 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 30 (n=1908) | 70.1 units on a scale | Standard Deviation 23.3 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 36 (n=1715) | 70.4 units on a scale | Standard Deviation 23.5 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 48 (n=1394) | 70.0 units on a scale | Standard Deviation 23.7 |
| Rheumatoid Arthritis | Hannover Functional Questionnaire (FFbH) Over Time | Month 60 (n=1048) | 69.9 units on a scale | Standard Deviation 24.1 |
Secondary
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.
Time frame: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set participants who were employed and with available data at each time point (indicated by n)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 30 (n=637) | 5.2 days | Standard Deviation 19.8 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 36 (n=566) | 5.2 days | Standard Deviation 21.9 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 0 (n=1503) | 51.0 days | Standard Deviation 78.7 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 6 (n=1173) | 11.6 days | Standard Deviation 35.5 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 12 (n=1016) | 8.6 days | Standard Deviation 30.9 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 18 (n=840) | 6.8 days | Standard Deviation 26 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 24 (n=744) | 4.9 days | Standard Deviation 19.8 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 48 (n=452) | 4.8 days | Standard Deviation 23.6 |
| Rheumatoid Arthritis | Number of Days Missed From Work Due to Rheumatoid Arthritis | Month 60 (n=339) | 1.8 days | Standard Deviation 9.5 |
Secondary
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.
Time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 0 (n=4389) | 6.0 cm | Standard Deviation 2.6 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 3 (n=4076) | 4.5 cm | Standard Deviation 2.7 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 6 (n=3491) | 4.2 cm | Standard Deviation 2.7 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 12 (n=2950) | 4.0 cm | Standard Deviation 2.6 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 18 (n=2491) | 3.8 cm | Standard Deviation 2.6 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 24 (n=2188) | 3.8 cm | Standard Deviation 2.6 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 30 (n=1906) | 3.7 cm | Standard Deviation 2.5 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 36 (n=1706) | 3.6 cm | Standard Deviation 2.5 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 48 (n=1381) | 3.6 cm | Standard Deviation 2.5 |
| Rheumatoid Arthritis | Participants Assessment of Fatigue Over Time | Month 60 (n=1039) | 3.6 cm | Standard Deviation 2.5 |
Secondary
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.
Time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 0 (n=4388) | 6.8 cm | Standard Deviation 2 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 3 (n=4079) | 4.7 cm | Standard Deviation 2.4 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 6 (n=3484) | 4.3 cm | Standard Deviation 2.4 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 12 (n=2966) | 4.1 cm | Standard Deviation 2.3 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 18 (n=2491) | 3.9 cm | Standard Deviation 2.3 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 24 (n=2190) | 3.9 cm | Standard Deviation 2.3 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 30 (n=1904) | 3.8 cm | Standard Deviation 2.3 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 36 (n=1712) | 3.7 cm | Standard Deviation 2.3 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 48 (n=1383) | 3.8 cm | Standard Deviation 2.3 |
| Rheumatoid Arthritis | Participants Assessment of Pain Over Time | Month 60 (n=1048) | 3.7 cm | Standard Deviation 2.3 |
Secondary
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.
Time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 0 (n=4400) | 6.6 cm | Standard Deviation 1.9 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 3 (n=4076) | 4.8 cm | Standard Deviation 2.2 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 6 (n=3483) | 4.5 cm | Standard Deviation 2.2 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 12 (n=2968) | 4.3 cm | Standard Deviation 2.1 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 18 (n=2489) | 4.1 cm | Standard Deviation 2.1 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 24 (n=2196) | 4.1 cm | Standard Deviation 2.1 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 30 (n=1903) | 4.0 cm | Standard Deviation 2.1 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 36 (n=1712) | 3.9 cm | Standard Deviation 2.1 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 48 (n=1386) | 3.9 cm | Standard Deviation 2.1 |
| Rheumatoid Arthritis | Patients Global Assessment of Disease Activity Over Time | Month 60 (n=1047) | 3.9 cm | Standard Deviation 2.1 |
Secondary
Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication
Time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 4.0 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 20.7 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 5.9 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 6.1 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 26.9 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 20.0 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 85.6 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 44.7 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 54.0 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 2.6 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 78.1 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 36.7 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 15.8 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 3.2 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 19.1 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 15.9 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 3.9 percentage of participants |
| Month 3 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 51.9 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 2.6 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 17.4 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 36.3 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 75.4 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 3.4 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 2.0 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 14.5 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 13.6 percentage of participants |
| Month 6 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 52.2 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 54.4 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 73.1 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 2.9 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 36.3 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 3.0 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 12.8 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 17.1 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 1.6 percentage of participants |
| Month 12 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 13.3 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 1.5 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 11.4 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 70.1 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 2.5 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 12.4 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 16.2 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 37.2 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 53.9 percentage of participants |
| Month 18 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 2.6 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 2.7 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 16.4 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 54.8 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 68.6 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 2.4 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 11.1 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 2.0 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 11.6 percentage of participants |
| Month 24 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 37.2 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 10.6 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 55.3 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 2.1 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 1.6 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 11.9 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 2.2 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 14.1 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 36.8 percentage of participants |
| Month 30 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 64.5 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 14.8 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 2.2 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 35.9 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 10.8 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 1.6 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 10.2 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 2.5 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 54.9 percentage of participants |
| Month 36 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 63.1 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 9.6 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 1.6 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 10.2 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 2.2 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 14.7 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 1.7 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 59.4 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 53.7 percentage of participants |
| Month 48 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 35.1 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Leflunomide | 8.9 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Analgesics | 14.2 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Hydroxychloroquine/Chloroquine | 1.3 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Other disease-modifying antirheumatic drug | 1.6 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Non-steroidal anti-inflammatory drug | 35.4 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Sulfasalazin | 1.4 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Systemic glucocorticoids | 58.1 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Cyclo-oxygenase 2 (COX-2) Inhibitors | 9.8 percentage of participants |
| Month 60 | Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication | Methotrexate | 54.6 percentage of participants |
Secondary
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.
Time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 3 (n=3918) | 40.8 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 6 (n=3347) | 50.5 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 12 (n=2872) | 53.6 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 18 (n=2397) | 58.7 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 24 (n=2099) | 60.3 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 30 (n=1810) | 63.3 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 36 (n=1564) | 64.6 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 48 (n=1261) | 64.2 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With a Significant Therapeutic Response | Month 60 (n=934) | 65.5 percentage of participants |
Secondary
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 6, 18, 24, and 30
Population: Full analysis set (FAS) participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Percentage of Participants With Impairment in Daily Activities | No days of impairment | 17.9 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Impairment in Daily Activities | Less than 7 days of impairment | 28.2 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Impairment in Daily Activities | 7 to 14 days of impairment | 28.0 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Impairment in Daily Activities | More than 14 days of impairment | 25.9 percentage of participants |
| Month 3 | Percentage of Participants With Impairment in Daily Activities | No days of impairment | 38.8 percentage of participants |
| Month 3 | Percentage of Participants With Impairment in Daily Activities | More than 14 days of impairment | 10.4 percentage of participants |
| Month 3 | Percentage of Participants With Impairment in Daily Activities | Less than 7 days of impairment | 34.7 percentage of participants |
| Month 3 | Percentage of Participants With Impairment in Daily Activities | 7 to 14 days of impairment | 16.1 percentage of participants |
| Month 6 | Percentage of Participants With Impairment in Daily Activities | More than 14 days of impairment | 7.2 percentage of participants |
| Month 6 | Percentage of Participants With Impairment in Daily Activities | Less than 7 days of impairment | 33.5 percentage of participants |
| Month 6 | Percentage of Participants With Impairment in Daily Activities | 7 to 14 days of impairment | 13.4 percentage of participants |
| Month 6 | Percentage of Participants With Impairment in Daily Activities | No days of impairment | 45.8 percentage of participants |
| Month 12 | Percentage of Participants With Impairment in Daily Activities | No days of impairment | 44.5 percentage of participants |
| Month 12 | Percentage of Participants With Impairment in Daily Activities | Less than 7 days of impairment | 35.3 percentage of participants |
| Month 12 | Percentage of Participants With Impairment in Daily Activities | More than 14 days of impairment | 7.1 percentage of participants |
| Month 12 | Percentage of Participants With Impairment in Daily Activities | 7 to 14 days of impairment | 13.1 percentage of participants |
| Month 18 | Percentage of Participants With Impairment in Daily Activities | More than 14 days of impairment | 6.0 percentage of participants |
| Month 18 | Percentage of Participants With Impairment in Daily Activities | 7 to 14 days of impairment | 12.8 percentage of participants |
| Month 18 | Percentage of Participants With Impairment in Daily Activities | Less than 7 days of impairment | 36.0 percentage of participants |
| Month 18 | Percentage of Participants With Impairment in Daily Activities | No days of impairment | 45.2 percentage of participants |
Secondary
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: Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set participants who were employed and with available data at each time point (indicated by n)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 0 (n=4341) | 27.6 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 6 (n=3401) | 10.9 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 12 (n=2924) | 7.4 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 18 (n=2467) | 6.7 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 24 (n=2177) | 6.4 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 30 (n=1900) | 5.3 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 36 (n=1706) | 6.2 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 48 (n=1370) | 5.0 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With In-patient Hospitalization | Month 60 (n=1037) | 5.3 percentage of participants |
Secondary
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.
Time frame: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS) participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 0.0 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 73.9 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 26.1 percentage of participants |
| Month 3 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 45.9 percentage of participants |
| Month 3 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 30.2 percentage of participants |
| Month 3 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 23.9 percentage of participants |
| Month 6 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 23.6 percentage of participants |
| Month 6 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 29.8 percentage of participants |
| Month 6 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 46.6 percentage of participants |
| Month 12 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 20.3 percentage of participants |
| Month 12 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 33.0 percentage of participants |
| Month 12 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 46.6 percentage of participants |
| Month 18 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 38.7 percentage of participants |
| Month 18 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 43.6 percentage of participants |
| Month 18 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 17.7 percentage of participants |
| Month 24 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 45.0 percentage of participants |
| Month 24 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 38.5 percentage of participants |
| Month 24 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 16.5 percentage of participants |
| Month 30 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 41.5 percentage of participants |
| Month 30 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 14.9 percentage of participants |
| Month 30 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 43.6 percentage of participants |
| Month 36 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 45.3 percentage of participants |
| Month 36 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 40.5 percentage of participants |
| Month 36 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 14.3 percentage of participants |
| Month 48 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 45.4 percentage of participants |
| Month 48 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 40.7 percentage of participants |
| Month 48 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 13.9 percentage of participants |
| Month 60 | Percentage of Participants With Low, Moderate and High Disease Activity | Low disease activity | 41.9 percentage of participants |
| Month 60 | Percentage of Participants With Low, Moderate and High Disease Activity | High disease activity | 12.8 percentage of participants |
| Month 60 | Percentage of Participants With Low, Moderate and High Disease Activity | Moderate disease activity | 45.3 percentage of participants |
Secondary
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, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 30 (n=1939) | 2.7 swollen joints | Standard Deviation 3.9 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 0 (n=4400) | 9.5 swollen joints | Standard Deviation 6.3 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 3 (n=4165) | 4.7 swollen joints | Standard Deviation 5.3 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 6 (n=3568) | 3.9 swollen joints | Standard Deviation 4.9 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 12 (n=3026) | 3.5 swollen joints | Standard Deviation 4.5 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 18 (n=2533) | 3.1 swollen joints | Standard Deviation 4.3 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 24 (n=2224) | 2.7 swollen joints | Standard Deviation 3.9 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 36 (n=1681) | 2.7 swollen joints | Standard Deviation 3.8 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 48 (n=1373) | 2.4 swollen joints | Standard Deviation 3.8 |
| Rheumatoid Arthritis | Swollen Joint Count (SJC) Over Time | Month 60 (n=1029) | 2.3 swollen joints | Standard Deviation 3.6 |
Secondary
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, 12, 18, 24, 30, 36, 48, and 60
Population: Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 0 (n=4400) | 12.3 tender joints | Standard Deviation 7.3 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 3 (n=4165) | 6.4 tender joints | Standard Deviation 6.7 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 6 (n=3568) | 5.4 tender joints | Standard Deviation 6.3 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 12 (n=3026) | 4.9 tender joints | Standard Deviation 6 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 18 (n=2533) | 4.4 tender joints | Standard Deviation 5.7 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 24 (n=2224) | 4.2 tender joints | Standard Deviation 5.5 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 30 (n=1939) | 4.1 tender joints | Standard Deviation 5.6 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 36 (n=1681) | 4.0 tender joints | Standard Deviation 5.4 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 48 (n=1373) | 3.9 tender joints | Standard Deviation 5.4 |
| Rheumatoid Arthritis | Tender Joint Count (TJC) Over Time | Month 60 (n=1029) | 3.9 tender joints | Standard Deviation 5.4 |