Clinical Trials Register

Summary
EudraCT Number:	2016-001772-30
Sponsor's Protocol Code Number:	RIDARTII
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-01
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-001772-30

A.3

Full title of the trial

Clinical burden of anemia in inflammatory bowel disease: Role of Iron Deficiency And iron Replacement Therapy, therapeutic trial

Impatto clinico dell’anemia nelle malattie infiammatorie intestinali: ruolo della carenza di ferro e della terapia sostitutiva con ferro, trial terapeutico (RIDART II)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Iron therapy in the treatment of anemia in inflammatory bowel disease

Terapia con ferro nel trattamento dell'anemia nelle malattie infiammatorie intestinali

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

RIDARTII

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Società Pharmanutra SpA
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	IG-IBD
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Policlinico San Matteo di Pavia
B.5.2	Functional name of contact point	Medicina generale I
B.5.3	Address:
B.5.3.1	Street Address	P.le Golgi 19
B.5.3.2	Town/ city	Pavia
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0382501016
B.5.5	Fax number	0382502618
B.5.6	E-mail	a.disabatino@smatteo.pv.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	FERLIXIT - 62.5 MG/5 ML SOLUZIONE PER USO ORALE E USO ENDOVENOSO 5 FIALE DA 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ferro e.v. (come gluconato ferrico)
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	gluconato ferrico sodico
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	FERINJECT - 50 MG/ML SOLUZIONE INIETTABILE O PER INFUSIONE 1 FLACONCINO IN VETRO DA 10 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	VIFOR FRANCE SA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ferro e.v. (come carbossimaltoso ferrico) - FERINJECT
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CARBOSSIMALTOSIO FERRICO
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Anemia in inflammatory bowel disease

Anemia nelle malattie infiammatorie intestinali

E.1.1.1

Medical condition in easily understood language

Anemia in inflammatory bowel disease

Anemia nelle malattie infiammatorie intestinali

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	HLT
E.1.2	Classification code	10017921
E.1.2	Term	Gastrointestinal inflammatory disorders NEC
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary endpoint of the trial is to compare the efficacy of oral iron with that of the iv iron supplementation regimens in the treatment of IDA in IBD. The primary comparison of interest regards the 2 combined iv regimens vs. the oral iron supplementation. Non inferiority of the oral regimen is hypothesized.

valutare, in termini di efficacia terapeutica, la non-inferiorità della supplementazione marziale per os rispetto a 2 modalità di supplementazione marziale per via parenterale endovenosa (ev) nei pazienti con IDA

E.2.2

Secondary objectives of the trial

To evaluate the influence of anemia and its treatment on fatigue, quality of life, hospitalizations, additional outpatient visits, number of endoscopic examinations; further treatments and relative side effects will be determined and these data will be used for a cost-effectiveness evaluation of different iron supplementation regimens

Valutare:
- la percentuale di pazienti partecipanti che ottengono la normalizzazione dei livelli di Hb o un incremento dell’Hb = 1.0 or 2.0 g/dL a 4, 8, 12 e 24 settimane dall’inizio del trattamento
- la frequenza, la natura e la gravità degli eventi avversi associati a ciascuno dei 3 bracci di trattamento
- il rapporto costo-efficacia per le diverse modalità di trattamento dell’IDA
- l’impatto che l’anemia ed il suo trattamento hanno sulla qualità della vita nei pazienti con IBD

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Have given written informed consent to participate
•Be aged 18 years and over
•Have IBD and IDA with or without inflammation
•Have a BMI >16

Verranno arruolati pazienti affetti da IBD e anemia da carenza di ferro con:
- età > 18 anni
- BMI > 16
- anemia con Hb < 13.0 g/dL per gli uomini e < 12.0 g/dL per le donne
- ferritina serica = 100 µg/L e saturazione della transferrina < 20%

E.4

Principal exclusion criteria

• Patients with hypersensitivity to the IMPs, to other iron containing products and to sucrose or benzil alcohol
• Pregnancy, lactation and women of childbearing potential (WOCBP) not willing to use highly efficient contraceptive measures
• history of erythropoietin treatment within 4 weeks prior to recruitment;
• alcohol abuse, liver cirrhosis, active hepatitis or signs of liver disease with a Child-Pugh class B or C;
• chronic renal failure stage 4 or higher
• major surgery in the previous 3 months;
• significant overt bleeding,
• acute severe anemia with hemodynamic instability;
• active malignancy
• any hematologic disease causing anemia;
• known active infection;
• known human immunodeficiency virus, HCV and HBV infections;
• evidence of tubercular (TB) infection

• pazienti con ipersensibilità agli IMP, a preparati contenenti ferro, al saccarosio o alcool benzilico
• donne incinta o in allattamento e donne in età fertile (WOCBP) che non fanno uso di efficaci misure anticoncezionali
• trattamento con eritropoietina nelle 4 settimane precedenti l’arruolamento
• abuso di alcool, cirrosi epatica, epatite attiva, , o segnali di malattia epatica con Child-Pugh classe B o C
• insufficienza renale cronica di stadio 4 o superiore
• interventi chirurgici maggiori negli ultimi 3 mesi;
• sanguinamenti significativi
• anemia acuta severa con instabilità emodinamica
• patologie maligne attive
• qualsiasi patologia ematologica che causi anemia
• infezioni attive
• infezione da HIV, infezioni HCV e HBV
• Evidenza di infezione tubercolare (TB)

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients responsive to iron supplementation. Response is defined by Hb normalization or by an Hb increase =2 g/dL by week 8. Normalization of Hb occurs with Hb values =12 g/dL in females or =13 g/dL in males.

Percentuale di pazienti che rispondono alla supplementazione di ferro. La risposta è definita dalla normalizzazione di Hb o da un incremento di Hb =2 g/dL alla settimana 8.
La normalizzazione di Hb si verifica con valori di Hb =12 g/dL nella femmina o =13 g/dL nel maschio.

E.5.1.1

Timepoint(s) of evaluation of this end point

week 8

settimana 8

E.5.2

Secondary end point(s)

-The proportion of responsive patients (defined according to criteria reported for the primary endpoint) plus patients with an Hb increase =1 g/dL at weeks 4, 8, 12 and 24; changes in Hb levels at the reported time points will be evaluated.
- Safety of the three iron supplementation treatments
- Costs-efficacy ratio - impact on quality of life

- la percentuale di pazienti responsivi (secondo i criteri indicati all’endpoint primario) più i pazienti con incremento di Hb = 1.0 o2.0 g/dL a 4, 8, 12 e 24 settimane dall’inizio del trattamento - Sarà valutata anche la variazione dei livelli di Hb alle scadenze temporali riportate
- la frequenza, la natura e la gravità degli eventi avversi associati a ciascuno dei 3 bracci di trattamento - il rapporto costo-efficacia per le diverse modalità di trattamento dell’IDA
- l’impatto che l’anemia ed il suo trattamento hanno sulla qualità della vita nei pazienti con IBD

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 4, 8, 12, 24

Settimana 4, 8, 12, 24

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Intergratore: ferro liposomiale (Sideral Forte), capsule orali da 30 mg di ferro, 1 o 2 cps/dì (sull

Supplement: liposomal iron (Sideral Forte), oral capsules each containing 30 mg elemental iron, 1 or

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

150

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-01.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will be treated according to guidelines and centre practice

I pazienti saranno trattati secondo le linee guida e la pratica del centro

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-13

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials