Rheumatoid Arthritis
Conditions
Brief summary
This 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician.
Interventions
BIOLOGICALInfliximab
Infliximab used in line with current clinical practice and local guidelines.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject has been diagnosed with RA * Physician has decided, with the subject's consent, to begin treatment with infliximab * Written informed consent form signed by both the subject and the physician.
Exclusion criteria
* Subjects who have previously been exposed to infliximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age | At Baseline | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis. |
| Baseline Raw DAS28 by Time Since Diagnosis | At Baseline | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis. |
| Baseline Raw DAS28 by Gender | At Baseline | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis. |
| Baseline Raw DAS28 by Country of Residence | At Baseline | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis. |
| Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | At Baseline | Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RA Subjects/ Infliximab 3 mg/kg Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®). | 728 |
| Total | 728 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject or treating physician's choice | 131 |
Baseline characteristics
| Characteristic | RA Subjects/ Infliximab 3 mg/kg |
|---|---|
| Age, Continuous | 54.1 years STANDARD_DEVIATION 13.08 |
| Sex: Female, Male Female | 571 Participants |
| Sex: Female, Male Male | 157 Participants |
| Time since diagnosis | 9.0 years STANDARD_DEVIATION 8.99 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 721 |
| serious Total, serious adverse events | 40 / 721 |
Outcome results
Primary
Baseline Raw DAS28 by Country of Residence
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.
Time frame: At Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Subjects/ Infliximab 3 mg/kg | Baseline Raw DAS28 by Country of Residence | 5.38 Score on a scale | Standard Deviation 0.9 |
| Male | Baseline Raw DAS28 by Country of Residence | 5.43 Score on a scale | Standard Deviation 1.22 |
| Female | Baseline Raw DAS28 by Country of Residence | 4.57 Score on a scale | Standard Deviation 1.16 |
| France | Baseline Raw DAS28 by Country of Residence | 4.97 Score on a scale | Standard Deviation 1.12 |
| Germany | Baseline Raw DAS28 by Country of Residence | 5.38 Score on a scale | Standard Deviation 1.23 |
| Greece | Baseline Raw DAS28 by Country of Residence | 5.15 Score on a scale | Standard Deviation 1.14 |
| Italy | Baseline Raw DAS28 by Country of Residence | 5.03 Score on a scale | Standard Deviation 1.05 |
| Netherlands | Baseline Raw DAS28 by Country of Residence | 5.07 Score on a scale | Standard Deviation 1.23 |
| Norway | Baseline Raw DAS28 by Country of Residence | 5.39 Score on a scale | Standard Deviation 1.13 |
| Poland | Baseline Raw DAS28 by Country of Residence | 5.83 Score on a scale | Standard Deviation 0.87 |
| Portugal | Baseline Raw DAS28 by Country of Residence | 5.08 Score on a scale | Standard Deviation 1.48 |
| Sweden | Baseline Raw DAS28 by Country of Residence | 4.96 Score on a scale | Standard Deviation 1.09 |
Comparison: Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)p-value: <0.0001ANOVA
Primary
Baseline Raw DAS28 by Gender
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.
Time frame: At Baseline
Population: Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Subjects/ Infliximab 3 mg/kg | Baseline Raw DAS28 by Gender | 5.2 Score on a scale | Standard Deviation 1.15 |
| Male | Baseline Raw DAS28 by Gender | 5.23 Score on a scale | Standard Deviation 1.11 |
| Female | Baseline Raw DAS28 by Gender | 5.19 Score on a scale | Standard Deviation 1.16 |
Comparison: Relationship between baseline DAS28 and gender (prior to infliximab therapy)p-value: 0.7152ANOVA
Primary
Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.
Time frame: At Baseline
Population: All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Subjects/ Infliximab 3 mg/kg | Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | 5.2 Score on a scale | Standard Deviation 1.15 |
| Male | Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | 5.3 Score on a scale | Standard Deviation 1.16 |
| Female | Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | 5.2 Score on a scale | Standard Deviation 1.14 |
| France | Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | 5.3 Score on a scale | Standard Deviation 1.16 |
Comparison: Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)95% CI: [5.1, 5.3]
Comparison: Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)95% CI: [5, 5.5]
Comparison: Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)95% CI: [5.1, 5.3]
Comparison: Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)95% CI: [5.1, 5.5]
Primary
Baseline Raw DAS28 by Time Since Diagnosis
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.
Time frame: At Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Subjects/ Infliximab 3 mg/kg | Baseline Raw DAS28 by Time Since Diagnosis | 5.2 Score on a scale | Standard Deviation 1.15 |
Comparison: Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)p-value: 0.7991Test for non-zero correlation
Primary
Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.
Time frame: At Baseline
Population: Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Subjects/ Infliximab 3 mg/kg | Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age | 5.2 Score on a scale | Standard Deviation 1.15 |
Comparison: Relationship between baseline DAS28 and age (prior to infliximab therapy)p-value: 0.0003Test for non-zero correlation