Crohn's Disease
Conditions
Keywords
anti-TNFa, immunization, kinoid, crohn's disease
Brief summary
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.
Interventions
BIOLOGICALTNFa Kinoid
TNFa kinoid at days 0, 7, 28
Sponsors
Neovacs
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have Active Crohn's Disease, as defined by a Crohn's Disease Activity Index (CDAI) score of \>220 but ≤400, with active Crohn's disease of ileum and/or colon (Other areas may be involved if ileum and/or colon are also involved)based upon either endoscopic, histologic and/or radiographic evidence * Patients with active disease despite treatment with 5-ASAs or sulfasalazine, corticosteroids (prednisone, budesonide, other), AZA or 6-MP or cyclosporine or MTX or Tacrolimus, ; OR intolerant of 5-ASAs or sulfasalazine; or intolerant of antibiotics; or intolerant of corticosteroids (prednisone, budesonide, other); or intolerant of AZA or 6-MP or cyclosporine or MTX or Tacrolimus * Patients might have previously responded to any prior anti-TNF agents and then lost response OR might be intolerant of any prior anti-TNF agents * Positive skin reaction to challenge with Candida antigens * Written informed consent
Exclusion criteria
* Prior history of tuberculosis or positive chest X ray or positive purified protein derivative skin test or positive interferon gamma TB assay * Signs or symptoms of clinically significant stricture of bowel. * Total parenteral nutrition or elemental diet required for treatment of disease or support of short bowel syndrome * Presence of an enteric stoma * Imminent or urgent surgery required for infection, abscess, bleeding or any other cause relating to their Crohn's Disease or other condition * History of malignancy. However, subjects with basal call carcinomas or less than 3 squamous cell carcinomas are allowed * History of asthma or serious allergic condition (including history of seafood allergy) * Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of study drug * History of opportunistic infection excluding oral candidiasis on steroids * Enteric infection as evidenced by positive stool C&S, O&P and C. difficile obtained during screening * Any significant or decompensated cardiac, neurologic, liver, pulmonary or renal disease * History of lymphoproliferative disorders * Clinically significant abnormal hematology values, as determined by the investigator, for hematocrit, hemoglobin, white blood cell count or platelets * Clinically significant abnormal blood chemistry values as determined by the investigator * Current significant drug or alcohol abuse as determined by the investigator * Positive for hepatitis C antibody or positive for hepatitis B surface antigen (HbsAg) or HIV infection * Surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures) * Participation in a clinical study (including previous participation in this study) within the previous 4 months * Had a primary non-response to any prior anti-TNF agents as defined by the investigator OR received any prior anti-TNF agents within the past 8 weeks prior to study entry * Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events | Whole study period |
Secondary
| Measure | Time frame |
|---|---|
| Antibody response | Day 38 |
Countries
South Africa, Switzerland
Outcome results
None listed