Status:
COMPLETED
Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease
Lead Sponsor:
Neovacs
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00808262
Start Date
October 1 2008
End Date
December 1 2010
Last Update
June 8 2011
Active Locations (6)
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1
Durbanville Medi-Clinic
Cape Town, Cape, South Africa, 7550
2
Parexel Port Elizabeth
Port Elizabeth, Eastern Cape, South Africa
3
Farmovs Parexel
Bloemfontein, South Africa
4
Parexel George
George, South Africa