Switching From Adalimumab to Infliximab

• Register: ClinicalTrials.gov
• Last refreshed on: 16 January 2023
• Main ID: NCT01338740
• Date of registration: 18/04/2011
• Prospective Registration: No
• Primary sponsor: University Hospital, Ghent
• Public title: Switching From Adalimumab to Infliximab ADA-IFX
• Scientific 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
• Date of first enrolment: April 2011
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01338740
• Study type: Observational

Countries of recruitment

Belgium

Contacts

• Name: Harald Peeters, Ph.D., M.D.
• Affiliation: University Hospital, Ghent

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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:

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.

Exclusion Criteria:

- 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.

- 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

1. Corticosteroids (prednisone, (methyl)prednisolone, budesonide):

stable dose for 2 weeks prior to baseline, then tapering at the discretion of the
investigator.

2. 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.

3. 5-ASA analogues (sulphasalazine, mesalazine): stable dose for 4 weeks prior to
baseline, stable dose until week 26 of the study.

4. Antibiotics (e.g. quinolone, metronidazole): stable dose for 2 weeks prior to
baseline.

5. 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.)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Adalimumab and Infliximab

Primary Outcome(s)

Assess efficacy of switching from Adalimumab to Infliximab. [Time Frame: after 10 weeks]

Secondary Outcome(s)

Treatment failure [Time Frame: during 52 weeks]

Sustained clinical remission without need for Infliximab therapy optimization. [Time Frame: after 26 and 52 weeks]

induction of clinical response [Time Frame: after 10 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]

induction of strong clinical response [Time Frame: after 10 weeks]

Sustained Clinical Response [Time Frame: after 26 and 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]

Secondary ID(s)

2010/566

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott