Inflammatory Bowel DiseasePhase 3FERNCT01428843
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
A Phase 3 study testing FERRISAT in people with Inflammatory Bowel Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 18 sites in France.
Trial summary
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation. Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- FERRISAT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 18 sitesFrance
- Study dates
- Jan 2011to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria
- Under anti-TNF therapy or indication for starting an anti-TNF therapy
- Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman)
- Iron deficiency anemia defined as:
- Ferritinemia under 100 if C-Reactive Protein under normal value OR - Ferritinemia between 30 and 100 if C-Reactive Protein above normal value
Who cannot join
- -
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Chu Amiens
Amiens, 80054
CHU CAEN
Caen, 14033
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Hopital Beaujon
Clichy, 92110
Hopital Bicetre
Le Kremlin-Bicêtre, 94275
CHRU Lille
Lille
Chu Marseille - Hopital Nord
Marseille, 13915
Chu Nantes
Nantes, 44093
Hopital Saint Louis
Paris, 75010
Hopital St Antoine
Paris, 75012
Hopital Cochin
Paris, 75014
CHU Bordeaux - Pessac
Pessac, 33700
CHU LYON
Pierre-Bénite, 69495
Chu Rennes
Rennes, 35033
Chu Rouen
Rouen, 76031
Chu Saint Etienne
Saint-Etienne, 42270
Chu Toulouse
Toulouse, 31403
Chu Tours
Tours, 37044
About this study
Official title: A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.
Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.
The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- FERRISAT, PLACEBO
- Keywords
- Inflammatory Bowel Disease, Anemia, Anti-TNF alpha theray, Ferrisat perfusion
- Medical subject headings
- Inflammatory Bowel Diseases, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FERRISATDrug
Also called ACTIVE FERRISAT
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
PLACEBODrug
Also called GLUCOSE 5%
A single infusion of Glucose 5% solution during inclusion visit
| Study group | Role | What they receive |
|---|---|---|
| Ferrisat | Active comparator | Infusion of Ferrisat (50mg/ml) at inclusion under usual practices Receives: Drug: FERRISAT |
| Placebo | Placebo comparator | Infusion of placebo at inclusion visit Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of hemoglobin
Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)
Measured: 6 weeks after inclusion
Secondary outcomes (2)
Tolerance of Ferrisat
Measured: At Inclusion
Improvement of quality of life
Measured: 6 weeks after perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume SAVOYE, PhD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesJean-Frédéric COLOMBEL, PhD, Study director, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428843
- Sponsor's protocol ID
- GETAID 2009-2
- Other IDs
- 2009-011316-38, 2009
- Acronym
- FER
- Status last verified
- Jun 2015
- First submitted
- 30 Aug 2011
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Oldenburg B, Koningsberger JC, Van Berge Henegouwen GP, Van Asbeck BS, Marx JJ. Iron and inflammatory bowel disease. Aliment Pharmacol Ther. 2001 Apr;15(4):429-38. doi: 10.1046/j.1365-2036.2001.00930.x.
PubMed 11284771Vijverman A, Piront P, Belaiche J, Louis E. Evolution of the prevalence and characteristics of anemia in inflammatory bowel diseases between 1993 and 2003. Acta Gastroenterol Belg. 2006 Jan-Mar;69(1):1-4.
PubMed 16673554Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14. doi: 10.1136/gut.8.2.107. No abstract available.
PubMed 6022337Wilson A, Reyes E, Ofman J. Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:44S-49S. doi: 10.1016/j.amjmed.2003.12.011.
PubMed 15050885Gasche C, Berstad A, Befrits R, Beglinger C, Dignass A, Erichsen K, Gomollon F, Hjortswang H, Koutroubakis I, Kulnigg S, Oldenburg B, Rampton D, Schroeder O, Stein J, Travis S, Van Assche G. Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases. Inflamm Bowel Dis. 2007 Dec;13(12):1545-53. doi: 10.1002/ibd.20285.
PubMed 17985376Gisbert JP, Gomollon F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. doi: 10.1111/j.1572-0241.2008.01846.x.
PubMed 18477354
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
- ClinicalTrials.gov ID
- NCT01428843
- Acronym / sponsor ID
- FER / GETAID 2009-2
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, Anemia, Anti-TNF alpha theray, Ferrisat perfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.
Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.
The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrisat | Active comparator | Drug: FERRISATInfusion of Ferrisat (50mg/ml) at inclusion under usual practices |
| Placebo | Placebo comparator | Drug: PLACEBOInfusion of placebo at inclusion visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than 18 years
- Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria
- Under anti-TNF therapy or indication for starting an anti-TNF therapy
- Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman)
- Iron deficiency anemia defined as:
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FERRISATAlso: ACTIVE FERRISATA single infusion of 50 mg/ml of Ferrisat during inclusion visit. | Drug | Ferrisat |
| PLACEBOAlso: GLUCOSE 5%A single infusion of Glucose 5% solution during inclusion visit | Drug | Placebo |
Primary outcome
Level of hemoglobin
Time frame: 6 weeks after inclusion
Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)
2 secondary outcomes
Tolerance of Ferrisat
Time frame: At Inclusion
Improvement of quality of life
Time frame: 6 weeks after perfusion
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Background: PubMed 11284771Oldenburg B, Koningsberger JC, Van Berge Henegouwen GP, Van Asbeck BS, Marx JJ. Iron and inflammatory bowel disease. Aliment Pharmacol Ther. 2001 Apr;15(4):429-38. doi: 10.1046/j.1365-2036.2001.00930.x.
- Background: PubMed 16673554Vijverman A, Piront P, Belaiche J, Louis E. Evolution of the prevalence and characteristics of anemia in inflammatory bowel diseases between 1993 and 2003. Acta Gastroenterol Belg. 2006 Jan-Mar;69(1):1-4.
- Background: PubMed 6022337Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14. doi: 10.1136/gut.8.2.107. No abstract available.
- Results publication: PubMed 15050885Wilson A, Reyes E, Ofman J. Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:44S-49S. doi: 10.1016/j.amjmed.2003.12.011.
- Results publication: PubMed 17985376Gasche C, Berstad A, Befrits R, Beglinger C, Dignass A, Erichsen K, Gomollon F, Hjortswang H, Koutroubakis I, Kulnigg S, Oldenburg B, Rampton D, Schroeder O, Stein J, Travis S, Van Assche G. Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases. Inflamm Bowel Dis. 2007 Dec;13(12):1545-53. doi: 10.1002/ibd.20285.
- Results publication: PubMed 18477354Gisbert JP, Gomollon F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. doi: 10.1111/j.1572-0241.2008.01846.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume SAVOYE, PhD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Jean-Frédéric COLOMBEL, PhD study director
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FERRISAT in people with Inflammatory Bowel Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of hemoglobin (time frame: 6 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428843, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.