Rheumatoid Arthritis
Conditions
Brief summary
This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)
Detailed description
This study population was chosen from a non-probability sample.
Interventions
BIOLOGICALInfliximab
Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians.
Sponsors
Centocor, Inc.
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Severe RA (indication according to Austrian labeling).
Exclusion criteria
* According to Summary of Product Characteristics (SPC).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Remicade Dose Per Participant | Maximum of 102 weeks | — |
| Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Maximum of 16 weeks | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. |
| Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Maximum of 102 weeks | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. |
| Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Maximum of 102 weeks | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. |
| Mean Remicade Dose Per Participant | Maximum of 102 weeks | — |
| Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Maximum of 16 weeks | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | 24 months maximum | Some participants had more than one previous treatment with a DMARD. |
| Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | 24 months maximum | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. |
| Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | 24 months maximum | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. |
| Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy | 24 months maximum | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration. | 516 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 25 |
| Overall Study | Continued treatment by other physician | 6 |
| Overall Study | Lack of Efficacy | 46 |
| Overall Study | Lost to Follow-up | 52 |
| Overall Study | Non-compliance | 8 |
| Overall Study | Physician Decision | 19 |
| Overall Study | Prepared for elective surgery | 1 |
| Overall Study | Reason not specified | 55 |
| Overall Study | Switched to other drug | 1 |
| Overall Study | Switched to other study | 1 |
| Overall Study | Withdrawal by Subject | 57 |
Baseline characteristics
| Characteristic | Remicade (Specialized Hospitals & Extramural Infusion Centers) |
|---|---|
| Age, Continuous | 55.43 years STANDARD_DEVIATION 13.52 |
| Sex: Female, Male Female | 398 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 516 |
| serious Total, serious adverse events | 21 / 516 |
Outcome results
Primary
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time frame: Maximum of 102 weeks
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=193, n=120, n=73) | 3.50 milligrams/kilograms (mg/kg) | Standard Deviation 0.62 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143, n=83, n=60) | 3.61 milligrams/kilograms (mg/kg) | Standard Deviation 0.72 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=178, n=110, n=68) | 3.56 milligrams/kilograms (mg/kg) | Standard Deviation 0.7 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=193, n=120, n=73) | 3.53 milligrams/kilograms (mg/kg) | Standard Deviation 0.67 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=193, n=120, n=73) | 3.42 milligrams/kilograms (mg/kg) | Standard Deviation 0.59 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=153, n=91, n=62) | 3.60 milligrams/kilograms (mg/kg) | Standard Deviation 0.72 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=193, n=120, n=73) | 3.46 milligrams/kilograms (mg/kg) | Standard Deviation 0.62 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=192, n=119, n=73) | 3.43 milligrams/kilograms (mg/kg) | Standard Deviation 0.59 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=163, n=99, n=64) | 3.63 milligrams/kilograms (mg/kg) | Standard Deviation 0.74 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=193, n=120, n=73) | 3.62 milligrams/kilograms (mg/kg) | Standard Deviation 0.71 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=193, n=120, n=73) | 3.50 milligrams/kilograms (mg/kg) | Standard Deviation 0.59 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=192, n=119, n=73) | 3.51 milligrams/kilograms (mg/kg) | Standard Deviation 0.59 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=193, n=120, n=73) | 3.56 milligrams/kilograms (mg/kg) | Standard Deviation 0.65 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=193, n=120, n=73) | 3.59 milligrams/kilograms (mg/kg) | Standard Deviation 0.63 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=178, n=110, n=68) | 3.70 milligrams/kilograms (mg/kg) | Standard Deviation 0.75 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=163, n=99, n=64) | 3.78 milligrams/kilograms (mg/kg) | Standard Deviation 0.82 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=153, n=91, n=62) | 3.75 milligrams/kilograms (mg/kg) | Standard Deviation 0.79 |
| Remicade (Specialized Hospitals Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143, n=83, n=60) | 3.79 milligrams/kilograms (mg/kg) | Standard Deviation 0.78 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=193, n=120, n=73) | 3.30 milligrams/kilograms (mg/kg) | Standard Deviation 0.54 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=193, n=120, n=73) | 3.30 milligrams/kilograms (mg/kg) | Standard Deviation 0.56 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=163, n=99, n=64) | 3.39 milligrams/kilograms (mg/kg) | Standard Deviation 0.53 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=192, n=119, n=73) | 3.31 milligrams/kilograms (mg/kg) | Standard Deviation 0.56 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143, n=83, n=60) | 3.36 milligrams/kilograms (mg/kg) | Standard Deviation 0.54 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=193, n=120, n=73) | 3.36 milligrams/kilograms (mg/kg) | Standard Deviation 0.58 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=193, n=120, n=73) | 3.36 milligrams/kilograms (mg/kg) | Standard Deviation 0.57 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=153, n=91, n=62) | 3.37 milligrams/kilograms (mg/kg) | Standard Deviation 0.53 |
| Remicade (Extramural Infusion Centers Only) | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=178, n=110, n=68) | 3.34 milligrams/kilograms (mg/kg) | Standard Deviation 0.54 |
Primary
Mean Remicade Dose Per Participant
Time frame: Maximum of 102 weeks
Population: Remicade-naive participants who were exposed to Remicade during the observational study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Remicade Dose Per Participant | 3.56 mg/kg | Standard Deviation 0.63 |
Primary
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time frame: Maximum of 16 weeks
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=193, n=120, n=73) | 56.48 Days | Standard Deviation 10.94 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=193, n=120, n=73) | 57.55 Days | Standard Deviation 10.81 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=178, n=110, n=68) | 56.80 Days | Standard Deviation 10.85 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=163, n=99, n=64) | 56.07 Days | Standard Deviation 8.57 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=153, n=91, n=62) | 57.33 Days | Standard Deviation 10.97 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143, n=83, n=60) | 57.04 Days | Standard Deviation 11.07 |
| Remicade (Specialized Hospitals Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143, n=83, n=60) | 56.60 Days | Standard Deviation 12.49 |
| Remicade (Specialized Hospitals Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=193, n=120, n=73) | 56.32 Days | Standard Deviation 7.76 |
| Remicade (Specialized Hospitals Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=163, n=99, n=64) | 55.41 Days | Standard Deviation 8.56 |
| Remicade (Specialized Hospitals Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=153, n=91, n=62) | 56.43 Days | Standard Deviation 12.11 |
| Remicade (Specialized Hospitals Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=193, n=120, n=73) | 56.83 Days | Standard Deviation 10.66 |
| Remicade (Specialized Hospitals Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=178, n=110, n=68) | 56.60 Days | Standard Deviation 13.07 |
| Remicade (Extramural Infusion Centers Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=193, n=120, n=73) | 58.73 Days | Standard Deviation 11.03 |
| Remicade (Extramural Infusion Centers Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=178, n=110, n=68) | 57.13 Days | Standard Deviation 5.75 |
| Remicade (Extramural Infusion Centers Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143, n=83, n=60) | 57.65 Days | Standard Deviation 8.8 |
| Remicade (Extramural Infusion Centers Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=163, n=99, n=64) | 57.09 Days | Standard Deviation 8.56 |
| Remicade (Extramural Infusion Centers Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=193, n=120, n=73) | 56.75 Days | Standard Deviation 14.82 |
| Remicade (Extramural Infusion Centers Only) | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=153, n=91, n=62) | 58.65 Days | Standard Deviation 8.97 |
Primary
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time frame: Maximum of 102 weeks
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=193, n=120, n=73) | 3.41 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143, n=83, n=60) | 3.53 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=178, n=110, n=68) | 3.41 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=193, n=120, n=73) | 3.39 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=193, n=120, n=73) | 3.33 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=153, n=91, n=62) | 3.53 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=193, n=120, n=73) | 3.33 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=192, n=119, n=73) | 3.33 mg/kg |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=163, n=99, n=64) | 3.53 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=193, n=120, n=73) | 3.53 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=193, n=120, n=73) | 3.38 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=192, n=119, n=73) | 3.39 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=193, n=120, n=73) | 3.40 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=193, n=120, n=73) | 3.49 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=178, n=110, n=68) | 3.61 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=163, n=99, n=64) | 3.70 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=153, n=91, n=62) | 3.70 mg/kg |
| Remicade (Specialized Hospitals Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143, n=83, n=60) | 3.70 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=193, n=120, n=73) | 3.23 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=193, n=120, n=73) | 3.23 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=163, n=99, n=64) | 3.33 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=192, n=119, n=73) | 3.23 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143, n=83, n=60) | 3.33 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=193, n=120, n=73) | 3.33 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=193, n=120, n=73) | 3.33 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=153, n=91, n=62) | 3.33 mg/kg |
| Remicade (Extramural Infusion Centers Only) | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=178, n=110, n=68) | 3.33 mg/kg |
Primary
Median Remicade Dose Per Participant
Time frame: Maximum of 102 weeks
Population: Remicade-naive participants who were exposed to Remicade during the observational study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Remicade Dose Per Participant | 3.49 mg/kg |
Primary
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time frame: Maximum of 16 weeks
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=193, n=120, n=73) | 57.00 Days |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=193, n=120, n=73) | 57.00 Days |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=178, n=110, n=68) | 57.00 Days |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=163, n=99, n-64) | 57.00 Days |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=153, n=91, n=62) | 57.00 Days |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143, n=83, n=60) | 57.00 Days |
| Remicade (Specialized Hospitals Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143, n=83, n=60) | 57.00 Days |
| Remicade (Specialized Hospitals Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=193, n=120, n=73) | 57.00 Days |
| Remicade (Specialized Hospitals Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=163, n=99, n-64) | 57.00 Days |
| Remicade (Specialized Hospitals Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=153, n=91, n=62) | 57.00 Days |
| Remicade (Specialized Hospitals Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=193, n=120, n=73) | 57.00 Days |
| Remicade (Specialized Hospitals Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=178, n=110, n=68) | 57.00 Days |
| Remicade (Extramural Infusion Centers Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=193, n=120, n=73) | 57.00 Days |
| Remicade (Extramural Infusion Centers Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=178, n=110, n=68) | 57.00 Days |
| Remicade (Extramural Infusion Centers Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143, n=83, n=60) | 57.00 Days |
| Remicade (Extramural Infusion Centers Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=163, n=99, n-64) | 57.00 Days |
| Remicade (Extramural Infusion Centers Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=193, n=120, n=73) | 57.00 Days |
| Remicade (Extramural Infusion Centers Only) | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=153, n=91, n=62) | 57.00 Days |
Secondary
Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy
Time frame: 24 months maximum
Population: Remicade-naive participants who were exposed to Remicade during the observational study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy | 8.02 Years | Standard Deviation 8.07 |
Secondary
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS
Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time frame: 24 months maximum
Population: Remicade-naive participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | Baseline (n=194, n=124) | 43.89 Score on a scale | Standard Deviation 17.98 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | Endpoint (after 9 infusions; n=125, n=13) | 67.10 Score on a scale | Standard Deviation 20.96 |
| Remicade (Specialized Hospitals Only) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | Baseline (n=194, n=124) | 45.12 Score on a scale | Standard Deviation 18.7 |
| Remicade (Specialized Hospitals Only) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | Endpoint (after 9 infusions; n=125, n=13) | 46.18 Score on a scale | Standard Deviation 25.71 |
Secondary
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)
Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time frame: 24 months maximum
Population: Remicade-naive participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | Baseline (n=194, n=121) | 31.25 Score on a scale | Standard Deviation 15.78 |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | Endpoint (after 9 infusions; n=125, n=13)) | 58.96 Score on a scale | Standard Deviation 22.26 |
| Remicade (Specialized Hospitals Only) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | Baseline (n=194, n=121) | 31.59 Score on a scale | Standard Deviation 16.81 |
| Remicade (Specialized Hospitals Only) | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | Endpoint (after 9 infusions; n=125, n=13)) | 42.46 Score on a scale | Standard Deviation 20.78 |
Secondary
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Some participants had more than one previous treatment with a DMARD.
Time frame: 24 months maximum
Population: Remicade-naive participants who were exposed to Remicade during the observational study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Sulfasalazine | 111 Participants |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Methotrexate | 470 Participants |
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Leflunomide | 138 Participants |