An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study

Phase 1

• Conditions: Crohn's disease; MedDRA version: 8.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2006-004784-58-GB
• Lead Sponsor: niversity of Leuven Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

To be eligible for the trial, patients must meet all of the following inclusion criteria:
1)Men and women = 18 and = 65 years of age,
2)Are capable of understanding and signing an informed consent
3)Are considered eligible according to the following tuberculosis (TB) screening criteria:
a)Have no history of latent or active TB prior to screening
b)Have no signs or symptoms suggestive of active TB upon medical history or physical examination
c)Have had no recent close contact with a person with active TB
d)Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of infliximab and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
4)The presence of active disease:
a)CDAI > 220
b)CRP > 5 mg/L (see amendment to protocol)
5)Strong Gadolinium (Gd) uptake on baseline contrast enhanced MRI enteroclysis (see MRI manual)
6)Ileal wall thickening of > 4 mm on baseline contrast enhanced MRI enteroclysis
7)Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last medication

Exclusion Criteria

Patients who meet any of the following criteria may not be enrolled in the study:
1)Have a medical contraindication for MRI enteroclysis (eg metal implants, including metal prosthetic heart valve(s), implantable devices, including a cardiac pacemaker and severe claustrophobia)
2)use more than 15 mg of oral steroids (prednisone or equivalent) within the 2 weeks prior to baseline MRI. IV use of steroids is not allowed within that same period
3)Have a severe prestenotic dilation of the ileum on screening MRI (severe dilation is defined as > 2 times the luminal diameter of the unaffected ileum)
4)Have had bowel resection of > 100 cm
5)Have presence of an abdominal abscess
6)Have MRI enteroclysis confirmed internal fistula
7)Be considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules (refer to sections 5.9 and 18).
8)Have Screening laboratory test results as follows:
a)White blood cells (WBCs) < 3.0 x 109 cells/L
b)Platelets < 100 X 109 cells/L
c)Serum creatinine > 132 µmol/L (> 1,5 mg/dL)
d)Serum transaminase levels exceeding 2 times the upper limit of normal for the site laboratory
9)Have had any previous treatment with monoclonal antibodies or antibody fragments
10)Have a history of receiving human/murine recombinant products or a known allergy to murine products
11)Have documentation of seropositivity for human immunodeficiency virus (HIV)
12)Have a positive test for hepatitis B surface antigen or hepatitis C
13)History of alcohol or substance abuse in the 6 months prior to the study
14)Have a known history of serious infections (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
15)Have a known history of a demyelinating disease, such as multiple sclerosis
16)Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria othe

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified