Rheumatoid Arthritis
Conditions
Brief summary
This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.
Detailed description
Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.
Interventions
DRUGInfliximab
Treatment of RA with Infliximab according to and under normal routine clinical practice.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.
Exclusion criteria
* episodic treatment with infliximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosing Interval Between the Infliximab Infusions | Measured from the Remicade Questionnaire at first (and only) study visit | Patients were asked as part of the Remicade questionnaire what dosing interval they were on. |
| Reason for Extending Dosing Interval | Measured from the Remicade Questionnaire at first (and only) study visit | Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient. |
| Patient Response to Increased Dosing Interval | Measured from the Remicade Questionnaire at first (and only) study visit | Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked did you notice any difference when your dosing interval was extended? Those who noticed a difference were asked if their experience was positive or negative. |
| Number of Patients Agreeing to Participate in a Dose Reduction Study | Measured from the Remicade Questionnaire at first (and only) study visit | As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry. | This is not a prespecified key secondary outcome; therefore, results will not be disclosed |
| Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire. | Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. | This is not a prespecified key secondary outcome; therefore, results will not be disclosed |
| Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage. | Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry. | This is not a prespecified key secondary outcome; therefore, results will not be disclosed |
Participant flow
Recruitment details
Information about patients' doctor visits prior to this study were obtained from the Swedish Rheumatology Register and the South Swedish Arthritis Treatment Group.
Pre-assignment details
RA patients in Sweden normally see their doctor every 6 months. Information obtained from these visits are entered into national registries. Data in this study were based on retrospective review of the two visits preceding the study visit and the visit when infliximab was prescribed for the 1st time, as well as the one and only study visit.
Participants by arm
| Arm | Count |
|---|---|
| RA Patients Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \>= the past 12 months. | 363 |
| Total | 363 |
Baseline characteristics
| Characteristic | RA Patients |
|---|---|
| Age, Continuous | 61 years |
| Change in dosing interval since previous doctor visit Data unavailable | 99 participants |
| Change in dosing interval since previous doctor visit Decreased dosing interval | 19 participants |
| Change in dosing interval since previous doctor visit Increased dosing interval | 19 participants |
| Change in dosing interval since previous doctor visit No change | 226 participants |
| Gender Female | 254 Participants |
| Gender Male | 109 Participants |
| Region of Enrollment Sweden | 363 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 363 |
| serious Total, serious adverse events | 0 / 363 |
Outcome results
Primary
Dosing Interval Between the Infliximab Infusions
Patients were asked as part of the Remicade questionnaire what dosing interval they were on.
Time frame: Measured from the Remicade Questionnaire at first (and only) study visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Patients | Dosing Interval Between the Infliximab Infusions | < every 8 weeks | 121 participants |
| RA Patients | Dosing Interval Between the Infliximab Infusions | every 8 weeks | 205 participants |
| RA Patients | Dosing Interval Between the Infliximab Infusions | > every 8 weeks | 37 participants |
Primary
Number of Patients Agreeing to Participate in a Dose Reduction Study
As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study?
Time frame: Measured from the Remicade Questionnaire at first (and only) study visit
Population: Out of the 363 subjects in the analysis, 361 subjects answered this question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Patients | Number of Patients Agreeing to Participate in a Dose Reduction Study | no | 139 participants |
| RA Patients | Number of Patients Agreeing to Participate in a Dose Reduction Study | yes | 222 participants |
Primary
Patient Response to Increased Dosing Interval
Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked did you notice any difference when your dosing interval was extended? Those who noticed a difference were asked if their experience was positive or negative.
Time frame: Measured from the Remicade Questionnaire at first (and only) study visit
Population: Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Patients | Patient Response to Increased Dosing Interval | positive | 4 participants |
| RA Patients | Patient Response to Increased Dosing Interval | negative | 75 participants |
Primary
Reason for Extending Dosing Interval
Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.
Time frame: Measured from the Remicade Questionnaire at first (and only) study visit
Population: Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Patients | Reason for Extending Dosing Interval | other | 9 participants |
| RA Patients | Reason for Extending Dosing Interval | decreased disease activity | 24 participants |
| RA Patients | Reason for Extending Dosing Interval | doctor's advice | 31 participants |
| RA Patients | Reason for Extending Dosing Interval | surgery/co-morbidity | 28 participants |
| RA Patients | Reason for Extending Dosing Interval | vacation/stay abroad | 14 participants |
| RA Patients | Reason for Extending Dosing Interval | pregnancy/trying to become pregnant | 0 participants |
Secondary
Adverse Events (AEs)
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Time frame: Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.
Secondary
Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Time frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.
Secondary
Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Time frame: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.