Iron-deficiency

any oral or intravenous prescription iron supplement

Iron Supplement

Praxis für Gastroenterologie

Klinik für Innere Medizin I des Universiätsklinikums

EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations

Type, severity and time of adverse events that are related to and caused by iron treatment (in the physician's opinion)

course over time, by Euroquol five-dimensional questionnaire

course over time, by fatigue-specific FACIT questionnaire

costs for days of hospitalisation and for physician contacts

Patients' Treatment Satisfaction for Medication (TSQM-9 questionnaire)

GWT-TUD GmbH

Shield Therapeutics

30 mg capsules to be taken orally twice a day for 52 weeks

Administered as per the local summary of product characteristics (SPC)

30 mg capsules to be taken orally twice a day
Ferric Maltol

Oral Ferric Iron Compound

Administered as per the local SmPC/PI
Ferric Carboxymaltose

Intravenous Iron

Total

Age, Customized

Sex: Female, Male

Race/Ethnicity, Customized

Fertility status (females)

Screening Hb for randomisation

Baseline Hb

IBD subgroup

Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (>12g/dL women, >13g/dL men) at Week 12 results per protocol (PP)

Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb (>12g/dL Women, >13g/dL Men) at Week 12

Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (>12g/dL women, >13g/dL men) at Week 12 results for intent to treat (ITT)

Change in hemoglobin concentration from baseline to Week 12.

Change in Hb Concentration From Baseline to Week 12

Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin <9.5 g/dL.

Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL

Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12.

Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12

Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.

Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12

Normal limits defined as women with hemoglobin concentration greater than 12 g/dL and men with hemoglobin concentration greater than 13 g/dL.

Number of Subjects With Hb Concentration Within Normal Limits at Week 12

Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12

Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 and 12 months; normalization of ferritin levels at 6 and 12 months.

Long Term Efficacy Endpoints i.e. Proportion of Subjects Who Are Non-anaemic at 6 and 12 Months; Normalization of Ferritin Levels at 6 and 12 Months

Change in hemoglobin concentration from baseline to Week 4.

Change in Hb Concentration From Baseline to Week 4

Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin <9.5 g/dL.

Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL

Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.

Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12

Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.

Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12

Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.

Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4

Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.

Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4

Number of Subjects With Hb Concentration Within Normal Limits at Week 4

Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4

Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.

Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4

Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4

Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4

A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research & general population surveys.
The SF-36 includes one multi-item scale that assesses 8 health components:
Physical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; & General Health Component.
These 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score & the Physical Component Score where higher values mean a better outcome.
Both scales range from 0 to 100, where higher scores indicate better health status.
The survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language.

Change From Baseline Physical Component and Mental Component Score

Number of Patients with Treatment-emergent Adverse Events (AEs).

Number of Patients With Treatment-emergent Adverse Events (AEs)

Number of Patients with Treatment-emergent Serious Adverse Events (SAEs).

Number of Patients With Treatment-emergent Serious Adverse Events (SAEs)

Overall Study

Dr Mark Sampson

Anemia, Iron-Deficiency

Inflammatory Bowel Disease

Crohn's Disease

Ferric Maltol

Ferric Carboxy Maltose

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease

maltol/upala

EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

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