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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients | Patients on maintenance therapy for RA with infliximab for >= the past 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Treatment of RA with Infliximab according to and under normal routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dosing Interval Between the Infliximab Infusions | Patients were asked as part of the Remicade questionnaire what dosing interval they were on. | 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. | 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. | 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?" | Measured from the Remicade Questionnaire at first (and only) study visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects are Swedish patients on maintenance therapy for RA with infliximab for >= the past 12 months.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21407184 | Result | Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15. |
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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.
Information about patients' doctor visits prior to this study were obtained from the Swedish Rheumatology Register and the South Swedish Arthritis Treatment Group.
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| ID | Title | Description |
|---|---|---|
| FG000 | RA Patients | Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for >= the past 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RA Patients | Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dosing Interval Between the Infliximab Infusions | Patients were asked as part of the Remicade questionnaire what dosing interval they were on. | Posted | Number | participants | Measured from the Remicade Questionnaire at first (and only) study visit |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RA Patients | Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Adverse Events (AEs) | This is not a prespecified key secondary outcome; therefore, results will not be disclosed | 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 | 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. |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Change in dosing interval since previous doctor visit | Only 264 patients had this information available from the registry databases. | Number | participants |
|
|
| 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 | Not Posted | 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. | Participants |
| Secondary | Adverse Events (AEs) | This is not a prespecified key secondary outcome; therefore, results will not be disclosed | Not Posted | Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry. | Participants |
| 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 | Not Posted | 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. | 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. | 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. | Posted | Number | participants | Measured from the Remicade Questionnaire at first (and only) study visit |
|
|
|
| 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. | 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. | Posted | Number | participants | Measured from the Remicade Questionnaire at first (and only) study visit |
|
|
|
| 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?" | Out of the 363 subjects in the analysis, 361 subjects answered this question. | Posted | Number | participants | Measured from the Remicade Questionnaire at first (and only) study visit |
|
|
|
| 0 |
| 363 |
| 0 |
| 363 |
PI agrees not to publish/publicly present any interim results of the Study. PI further agrees to provide 45 days written notice to Sponsor prior to submission for publication/presentation to permit Sponsor to review drafts of any material before publication which report any results arising out of the Study. Sponsor shall have the right to review and comment.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| vacation/stay abroad |
|
| pregnancy/trying to become pregnant |
|
| other |
|