Iron-Deficiency Anemia, Iron-Deficiency
Conditions
Keywords
Iron isomaltoside 1000, Iron Derisomaltose 1000
Brief summary
Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.
Interventions
Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000
Sponsors
Pierre Fabre Pharma AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Legally capable male and female patients, aged ≥ 18 years (no upper limit); * Written informed consent of the patient with regard to the pseudonymized documentation; * The patients are not selected by specific inclusion or
Exclusion criteria
, but by the indication listed in the Swiss SmPC (Summary of Product Characteristics) of Monofer®; * Decision is taken to treat the patient with IIM in accordance with the current Swiss SmPC of Monofer® and by prescription; this decision is taken prior to and independent from the inclusion into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attitude of patients towards IV iron treatment evaluated with questionnaire. | Change from baseline taking into account baseline (BL) and follow-up (FU) answers. Follow-up at the latest 12 weeks after observed dosing and before a potential subsequent dosing (if available based on clinical routine follow-up). | Rate of patients with stability or positive change in attitude. Questionnaire comprises the following questions: 1. I am hesitant to be treated with IV iron. 2. I would consider IV iron treatment due to the physician ́s choice. 3. I would consider IV iron treatment due to its safety compared to other iron treatment options. 4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attitude of patients towards IIM treatment evaluated with questionnaire. | Complete observation time-frame (the total observation period of this study will amount to 90 months). | Taking into account baseline (BL) and follow-up (FU) answers. Questionnaire comprises the following questions: 1. I am hesitant to be treated with IIM. 2. I would consider IIM treatment due to the physician ́s choice. 3. I would consider IIM treatment due to its safety compared to other iron treatment options. 4. I would consider IIM treatment due to its efficacy compared to other iron treatment options. 5. I would consider IIM treatment due to its specific dosing and administration schedule. |
| Attitude of physicians towards IIM and IV iron treatment evaluated with questionnaire. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Questionnaire comprises the following questions: 1. I am hesitant to treat with IV iron. 2. I would consider IV iron treatment due to the patient ́s desire. 3. I would consider IV iron treatment due to its safety compared to other iron treatment options. 4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options. And: 1. I am hesitant to treat with IIM. 2. I would consider IIM treatment due to the patient ́s desire. 3. I would consider IIM treatment due to its safety compared to other iron treatment options. 4. I would consider IIM treatment due to its efficacy compared to other iron treatment options. 5. I would consider IIM treatment due to its specific dosing and administration schedule. |
| Patient and disease profiles at baseline. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Evaluation of kind of iron deficiency. |
| Calculation of iron need based on IIM simplified dosing scheme. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Evaluation of dosing intensity of IIM. |
| Treatment sequence before IIM. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Dose intensities of administration. |
| Reason(s) for selection of IIM. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Reasons for treatment choice of IIM in current patient populations. Reasons could be: efficacy, safety profile, quality of life, patient's preference, physician's preference, comorbidities, convenient dosing, other. |
| Effectiveness of treatment with IIM. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL. |
| Treatment satisfaction of physician and patient upon treatment. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Rate of physicians and patients with stability or positive change in satisfaction upon IIM treatment. |
| Effectiveness of treatment with IIM: whole blood count changes. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Red blood cell count |
| Effectiveness of treatment with IIM: total Hb increase. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Hemoglobin |
| Effectiveness of treatment with IIM: serum ferritin increase. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Serum ferritin |
| Effectiveness of treatment with IIM: CRP (C-reactive protein) status. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | CRP status. |
| Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions). | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Number of patients with: * Treatment-emergent adverse events (maximum grade per patient), * Grade 3/4 treatment-emergent adverse drug reactions, * Grade 3/4 treatment-emergent serious adverse events, * Treatment-emergent serious adverse drug reactions, * Pre-treatment adverse events, * Pre-treatment serious adverse events, * Follow-up adverse events, * Follow-up serious adverse events. |
| Treatment with IIM. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). | Dose intensity of administration. |
Countries
Switzerland
Outcome results
None listed