Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )

Study Overview
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Brief Summary
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The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability.

Detailed Description
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The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability. By describing the characteristics of patients treated with Feraccru® and their outcomes, this study will provide the medical community with important information to support treatment decisions for their patients. This will ultimately support improvements to patient care, including the long-term outcomes of patients with IBD and IDA

Official Title
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Feraccru® Real World Effectiveness Study in Hospital Practice (FRESH): A Real World Study to Describe the Outcomes Associated With the Use of Ferric Maltol (Feraccru) for the Management of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease in the UK.

Conditions
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Anemia, Iron Deficiency, Inflammatory Bowel Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged ≥ 18 years at the time of initiation . Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and <13.0 g/dL in males, or Hb ≥9.5 g/dL and <12.0 g/dL in females Serum ferritin concentration <30 microgram/L or transferrin saturation of <20% . Patient receiving Feraccru® since the time of UK launch in June 2016. Exclusion Criteria: Patient receiving Feraccru® as part of an interventional clinical trial. Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®. Patient with an IBD flare, as determined by the clinician. Patient with medical records that are not available for review. Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. | Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males. | 12 weeks (permitting 10-16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hb Levels at Week 4 | Change in Haemoglobin levels from baseline to Week 4 | Baseline to Week 4 (permitting 3 to 5 weeks) | 
| Change in Hb Levels at 12 Weeks | Change in Haemoglobin levels from baseline to Week 12 | Baseline to Week 12 (permitting 10-16 weeks) | 
| Time to Normalisation of Hb Levels | Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males. | Baseline to 12 weeks (permitting 10-16 weeks) | 
| Change in Serum Ferritin Levels at Week 4 | Change in serum ferritin levels from baseline to week 4 | Baseline to Week 4 (permitting 3 to 5 weeks) | 
| Change in Serum Ferritin Levels at Week 12 | Change in serum ferritin levels from baseline to week 12 | Baseline to Week 12 (permitting 10-16 weeks) | 
| Percentage of Patients With Normalised Ferritin Levels at 12 Weeks | Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L. | Baseline to Week 12 (permitting 10-16 weeks) | 
| Time to Correction of Serum Ferritin Levels | Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L. | Baseline to Week 12 (permitting 10 to 16 weeks) | 
| Change in Transferrin Saturation at Week 4 | Change in transferrin saturation (TSAT) at Week 4 | Baseline to Week 4 (permitting 3 to 5 weeks) | 
| Change in Transferrin Saturation at Week 12 | Change in transferrin saturation (TSAT) at Week 12 | Baseline to Week 12 | 
| Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru® | Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%. | Baseline to Week 12 | 
| Time to Correction of Transferrin Saturation | Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%. | Baseline to Week 12 | 
| Time From Diagnosis of IBD to Initiation of Feraccru | Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru. | Baseline | 
| Time From Diagnosis of IDA to Initiation of Feraccru® | Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru® | Baseline | 
| Prior IV Treatment History | Prior intravenous iron treatment history | Baseline | 
| Reason for Initiating Feraccru® | Reason(s) for initiation of Feraccru® | Baseline | 
| Percentage of Patients Who Discontinue Feraccru® | Percentage of patients who discontinue Feraccru® during the 12 weeks period | Baseline to week 12 | 
| Reason for Discontinuing Feraccru® | Reasons for stopping will be collected as predefined common options and a free text field. | Baseline to week 12 | 
| Adverse Events That Are Related to and Caused by Feraccru® | Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru® | For the duration of study, average of 12 weeks. | 
| Reason for Discontinuing Each Prior Oral Ferrous Product | Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP. | Baseline |