Crohn's DiseaseADA-IFXNCT01338740
Switching From Adalimumab to Infliximab
An observational study of Crohn's Disease, run by University Hospital, Ghent at 16 sites in Belgium.
Trial summary
Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy of switching to Infliximab in patients with loss of response or primary non-response to Adalimumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Adalimumab and Infliximab
- How many people
- 21 participants
- Where
- 16 sitesBelgium
- Study dates
- Apr 2011to 17 Feb 2014
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab, switch to Infliximab.
Who may be able to join
- Diagnosis of Crohn's disease confirmed by radiological, endoscopical or histological evidence.
- Moderately to severely active Crohn's disease: Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 450, scored during the screening period.
- Primary non-response to Adalimumab induction (160mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks: q2w), defined as CDAI ≥ 220 in combination with C-Reactive Protein (CRP) ≥ 0.5mg/dl or endoscopic or radiological evidence of disease activity and evaluated 2 weeks after 6 injections (q2w) of Adalimumab (injections week 0 to week 10, evaluation week 12). OR Loss of response to Adalimumab, defined as CDAI ≥ 220 in combination with CRP ≥ 0.5mg/dl or endoscopic or radiological evidence of disease activity and after at least 4 weeks of weekly injections of Adalimumab (40mg).
- Male or female aged 18-75 years old.
- No history, signs or symptoms of active or latent, untreated tuberculosis (TB).
- Having laboratory results as follows:
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- Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels not exceeding 2 times the upper limit of normal for the central laboratory conducting the test Serum creatinine not exceeding 1.7 mg/dl. Platelets ≥ 100 x 103 cells/µl. Neutrophils ≥ 1.5 x 103 cells/µl.
- Having met all concomitant medication criteria:
- Capable of providing informed consent, prior to any study related procedure.
Who cannot join
- Exclusively fistulising Crohn's disease or exclusive involvement of the upper gastrointestinal (GI) tract.
- Subject with abscess or suspicion of abscess.
- Subject with obstructive fibrotic strictures (with prestenotic dilatation).
- Subject with short bowel syndrome.
- Subject who has had a surgical bowel resection within the past 6 months or planning of any resection at the time while enrolled in the study.
- Subject with Ulcerative Colitis or Indeterminant Colitis.
Show all 32Show fewer
- Subject with ostomy or ileoanal pouch.
- Subject who is currently receiving total parenteral nutrition.
- Subject who has previously been treated with Infliximab or Certolizumab Pegol.
- Subject with positive stool cultures for enteric pathogens or positive C. difficile toxins during screening period.
- Subject who has received any investigational drug within 12 weeks prior to screening.
- Subject with a history of drug or alcohol abuse within the past 3 years.
- Females who are pregnant or breast feeding.
- Females of child bearing age not practicing effective birth control.
- Subject with a history of malignancy irrespective of time (except carcinoma- in situ of cervix or basal cell carcinoma or squamous cell carcinoma that was successfully treated).
- Subject with a history or symptoms of lymphoproliferative disease.
- Subject with a history of Human Immunodeficiency Virus (HIV), chronic or active Hepatitis B.
- History of Congestive Heart Failure (CHF), including medically controlled asymptomatic CHF.
- Subject who currently has or had an opportunistic infection (e.g. cytomegalovirus (CMV), pneumocystis carinii, aspergillosis, histoplasmosis, coccidioidomycosis) within 6 months prior to screening.
- Subject who currently has an active infection.
- Subject who has a transplanted organ (except for corneal transplant).
- History of known demyelinating disease such as optic neuritis or multiple sclerosis.
- Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or cerebral disease.
- CONCOMITANT MEDICATION
- Corticosteroids (prednisone, (methyl)prednisolone, budesonide):
- stable dose for 2 weeks prior to baseline, then tapering at the discretion of the investigator.
- Immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate):
- patients taking this medication prior to baseline: stable dose for 8 weeks prior to baseline, then stable dose until week 26 of the study. Starting or restarting of immunosuppressants is allowed until week 2, then stable dose until week 26 of the study.
- 5-ASA analogues (sulphasalazine, mesalazine): stable dose for 4 weeks prior to baseline, stable dose until week 26 of the study.
- Antibiotics (e.g. quinolone, metronidazole): stable dose for 2 weeks prior to baseline.
- Adalimumab: at least 2 week washout period prior to first Infliximab infusion.
- Starting or increasing the dose of other medication for Crohn's disease than Infliximab during the study will be considered as "treatment failure". (except for immunosuppressants as described above under 2.)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Belgium16 sites
Sint-Augustinus
Antwerp
UZ Antwerpen
Antwerp
Imelda Hospital
Bonheiden
Cliniques Universitaires Saint-Luc
Brussels
ULB université libre (erasme)
Brussels
Ziekenhuis Oost-Limburg
Genk
University Hospital Ghent
Ghent
Virga Jesse hospital
Hasselt
AZ Groeninge
Kortrijk
UZ Leuven
Leuven
CHC (Centre Hospitalier Chrétien)
Liège
CHU de liège
Liège
Hospital Maas en kempen
Maaseik
AZ Damiaan
Ostend
Clinique Saint-Pierre
Ottignies
Heilig Hartziekenhuis Roeselare
Roeselare
About this study
Official title: Prospective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to Adalimumab
Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy of switching to Infliximab in patients with loss of response or primary non-response to Adalimumab. Even in rheumatology, where switching between all classes of anti-TNFα biologicals is common practice, there are no scientific data on switching from humanized to chimeric anti-TNFα antibodies.
The purpose of this study is to document the efficacy of such a switch and to identify the possible predictive factors for success.
Read more
If treatment with Adalimumab fails (despite optimal dose and interval) and the treating physician therefore decided to switch to infliximab, the patient may be enrolled in this observational study. At regular intervals (every Remicade), the patient will be clinically re-evaluated. The disease activity score will be calculated: Crohn's disease activity index (CDAI). At regular intervals, the results of interim blood tests will be documented (3x). The succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken for determination of antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab (week 0) and Infliximab (week 10, 26 and 52) will be determined.
For this study there is no specific therapy change. The study wants only to document the results of a therapy switch that, in current clinical practice, is made by the treating physician.
- Conditions
- Crohn's Disease
- Being tested
- Adalimumab and Infliximab
- Keywords
- Chrohn's disease, Moderate to severely active Crohn's disease patients
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab and InfliximabDrug
Patients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab switch to Infliximab.
| Study group | Role | What they receive |
|---|---|---|
| Switch from Adalimumab to Infliximab | Moderately to severely active Crohn's disease patients with primary non-response or loss of response to Adalimumab, will switch to Infliximab. Receives: Drug: Adalimumab and Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess efficacy of switching from Adalimumab to Infliximab.
The primary objective of the study is to assess the efficacy of switching to Infliximab for the induction of clinical remission in subjects with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab.
The proportion of subjects achieving clinical remission at week 10 after 3 infusions of Infliximab (week 0, 2 and 6). Clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 or less.
Measured: after 10 weeks
Secondary outcomes (9)
induction of clinical response
To assess the efficacy of switching from Adalimumab to Infliximab for the induction of clinical response. The proportion of subjects with clinical response (at least 70 point decrease in Crohn's Disease Activity Index (CDAI)) at week 10.
Measured: after 10 weeks
induction of strong clinical response
To assess the efficacy of switching from Adalimumab to Infliximab for the induction of strong clinical response.
The proportion of subjects with strong clinical response (at least 100 point decrease in CDAI) at week 10.
Measured: after 10 weeks
Sustained Clinical Response
To assess the efficacy of switching from Adalimumab to Infliximab to achieve sustained clinical response, treating with maintenance Infliximab infusions.
The proportion of subjects with sustained clinical response (at least 100 and 70 point decrease in CDAI) at weeks 26 and 52.
Measured: after 26 and 52 weeks
Sustained Clinical Remission
To assess the efficacy of switching from Adalimumab to Infliximab to achieve sustained clinical remission, treating with maintenance Infliximab infusions.
The proportion of subjects with sustained clinical remission (CDAI 150 or less) at weeks 26 and 52.
Measured: after 26 and 52 weeks
Induction and maintenance of steroid-free remission.
To assess the efficacy of switching from Adalimumab to Infliximab for the induction and maintenance of steroid-free remission.
The proportion of subjects with steroid-free remission (CDAI 150 or less) at weeks 10, 26 and 52.
Measured: after 10, 26 and 52 weeks
Sustained clinical remission without need for Infliximab therapy optimization.
To assess the efficacy of switching from Adalimumab to Infliximab to achieve sustained clinical remission, treating with maintenance Infliximab infusions, without the need for Infliximab therapy optimization (interval shortening or dose increase).
The proportion of subjects with sustained clinical remission (CDAI 150 or less) at weeks 26 and 52, without the need for Infliximab therapy optimization (interval shortening or dose increase).
Measured: after 26 and 52 weeks
Treatment failure
To assess the treatment failure of switching from Adalimumab to Infliximab. The proportion of patients with treatment failure. Failure is defined as cessation of Infliximab due to intolerance or insufficient efficacy despite therapy optimization or the start or dose increase of any other Crohn's disease medication during the study (including corticosteroids, immunosuppressants and 5-aminosalicylic acid (5-ASA) analogues).
Measured: during 52 weeks
Tolerance and safety for switching from Adalimumab to Infliximab.
Adverse events/Serious adverse events will be analysed. Hematology and biochemistry will be analysed at weeks 10, 26 and 52.
Measured: After 10, 26 and 52 weeks.
Serological factors associated with switching from Adalimumab to Infliximab.
- C-Reactive Protein (CRP) at screening, weeks 10, 26 and 52.
- Antibodies to Adalimumab at baseline, weeks 10, 26 and 52.
- Trough level of Adalimumab at baseline.
- Antibodies to Infliximab at weeks 10, 26 and 52.
- Trough level of Infliximab at weeks 10, 26 and 52.
Measured: after 10, 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completion17 Feb 2014
- Study completion17 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Harald Peeters, Ph.D., M.D., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338740
- Sponsor's protocol ID
- 2010/566
- Acronym
- ADA-IFX
- Status last verified
- Jan 2023
- First submitted
- 18 Apr 2011
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to Adalimumab
- ClinicalTrials.gov ID
- NCT01338740
- Acronym / sponsor ID
- ADA-IFX / 2010/566
- Conditions
- Crohn's Disease
- Keywords
- Chrohn's disease, Moderate to severely active Crohn's disease patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2011 (actual)
- Primary completion
- 17 Feb 2014 (actual)
- Study completion
- 17 Feb 2014 (actual)
- First posted
- 19 Apr 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.
Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy of switching to Infliximab in patients with loss of response or primary non-response to Adalimumab. Even in rheumatology, where switching between all classes of anti-TNFα biologicals is common practice, there are no scientific data on switching from humanized to chimeric anti-TNFα antibodies.
The purpose of this study is to document the efficacy of such a switch and to identify the possible predictive factors for success.
If treatment with Adalimumab fails (despite optimal dose and interval) and the treating physician therefore decided to switch to infliximab, the patient may be enrolled in this observational study. At regular intervals (every Remicade), the patient will be clinically re-evaluated. The disease activity score will be calculated: Crohn's disease activity index (CDAI). At regular intervals, the results of interim blood tests will be documented (3x). The succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken for determination of antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab (week 0) and Infliximab (week 10, 26 and 52) will be determined.
For this study there is no specific therapy change. The study wants only to document the results of a therapy switch that, in current clinical practice, is made by the treating physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switch from Adalimumab to Infliximab | – | Drug: Adalimumab and InfliximabModerately to severely active Crohn's disease patients with primary non-response or loss of response to Adalimumab, will switch to Infliximab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab, switch to Infliximab.
Key inclusion criteria (9 listed)
- Diagnosis of Crohn's disease confirmed by radiological, endoscopical or histological evidence.
- Moderately to severely active Crohn's disease: Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 450, scored during the screening period.
- Primary non-response to Adalimumab induction (160mg at week 0, 80 mg at week 2, then 40 mg every 2 weeks: q2w), defined as CDAI ≥ 220 in combination with C-Reactive Protein (CRP) ≥ 0.5mg/dl or endoscopic or radiological evidence of disease activity and evaluated 2 weeks after 6 injections (q2w) of Adalimumab (injections week 0 to week 10, evaluation week 12). OR Loss of response to Adalimumab, defined as CDAI ≥ 220 in combination with CRP ≥ 0.5mg/dl or endoscopic or radiological evidence of disease activity and after at least 4 weeks of weekly injections of Adalimumab (40mg).
- Male or female aged 18-75 years old.
- No history, signs or symptoms of active or latent, untreated tuberculosis (TB).
Key exclusion criteria (32 listed)
- Exclusively fistulising Crohn's disease or exclusive involvement of the upper gastrointestinal (GI) tract.
- Subject with abscess or suspicion of abscess.
- Subject with obstructive fibrotic strictures (with prestenotic dilatation).
- Subject with short bowel syndrome.
- Subject who has had a surgical bowel resection within the past 6 months or planning of any resection at the time while enrolled in the study.
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 |
|---|---|---|
| Adalimumab and InfliximabPatients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab switch to Infliximab. | Drug | Switch from Adalimumab to Infliximab |
Primary outcome
Assess efficacy of switching from Adalimumab to Infliximab.
Time frame: after 10 weeks
The primary objective of the study is to assess the efficacy of switching to Infliximab for the induction of clinical remission in subjects with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab. The proportion of subjects achieving clinical remission at week 10 after 3 infusions of Infliximab (week 0, 2 and 6). Clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 or less.
9 secondary outcomes
induction of clinical response
Time frame: after 10 weeks
induction of strong clinical response
Time frame: after 10 weeks
Sustained Clinical Response
Time frame: after 26 and 52 weeks
Sustained Clinical Remission
Time frame: after 26 and 52 weeks
Induction and maintenance of steroid-free remission.
Time frame: after 10, 26 and 52 weeks
Sustained clinical remission without need for Infliximab therapy optimization.
Time frame: after 26 and 52 weeks
Treatment failure
Time frame: during 52 weeks
Tolerance and safety for switching from Adalimumab to Infliximab.
Time frame: After 10, 26 and 52 weeks.
Serological factors associated with switching from Adalimumab to Infliximab.
Time frame: after 10, 26 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Related InfoLink provided by the sponsor.
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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.
Harald Peeters, Ph.D., M.D. principal investigator
University Hospital, Ghent
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by University Hospital, Ghent at 16 sites in Belgium.
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 9 inclusion and 32 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: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess efficacy of switching from Adalimumab to Infliximab. (time frame: after 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2023.