An observational study in Rheumatoid Arthritis, sponsored by Merck Sharp & Dohme LLC. Completed. Per ClinicalTrials.gov, last updated 2017-01-04.
Sponsored by Merck Sharp & Dohme LLC · Observational
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.
Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 363 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects are Swedish patients on maintenance therapy for RA with infliximab for >= the past 12 months.
Exclusion Criteria:
Patients on maintenance therapy for RA with infliximab for \>= the past 12 months.
Drug: Infliximab
Treatment of RA with Infliximab according to and under normal routine clinical practice.
Also known as: Remicade, SCH 215596
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
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
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
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
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.
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.
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.
Information about patients' doctor visits prior to this study were obtained from the Swedish Rheumatology Register and the South Swedish Arthritis Treatment Group.
| Milestone | RA Patients |
|---|---|
| Started | 363 |
| Completed | 363 |
| Not completed | 0 |
Patients were asked as part of the Remicade questionnaire what dosing interval they were on.
| participants | RA Patients |
|---|---|
| < every 8 weeks | 121 |
| every 8 weeks | 205 |
| > every 8 weeks | 37 |
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Results for this outcome have not been posted.
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Results for this outcome have not been posted.
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
Results for this outcome have not been posted.
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.
| participants | RA Patients |
|---|---|
| decreased disease activity | 24 |
| doctor's advice | 31 |
| surgery/co-morbidity | 28 |
| vacation/stay abroad | 14 |
| pregnancy/trying to become pregnant | 0 |
| other | 9 |
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.
| participants | RA Patients |
|---|---|
| positive | 4 |
| negative | 75 |
As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"
| participants | RA Patients |
|---|---|
| no | 139 |
| yes | 222 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RA Patients | — | 0/363 (0%) | 0/363 (0%) |
| Age, Continuous(years) | RA Patients |
|---|---|
| Mean | 61 (23 to 89) |
| Gender(Participants) | RA Patients |
|---|---|
| Female | 254 |
| Male | 109 |
| Region of Enrollment(participants) | RA Patients |
|---|---|
| Sweden | 363 |
| Change in dosing interval since previous doctor visit(participants) | RA Patients |
|---|---|
| Decreased dosing interval | 19 |
| No change | 226 |
| Increased dosing interval | 19 |
| Data unavailable | 99 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC