Working... Menu

Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00808262
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : June 8, 2011
Information provided by:

Brief Summary:
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: TNFa Kinoid Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Escalating Dose, "Optimal Two-stage", Study of TNFα-Kinoid (TNF- K) Immunization in Crohn's Disease Patients
Study Start Date : October 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: TNFa Kinoid dose 1 Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28

Experimental: TNFa Kinoid dose 2 Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28

Experimental: TNFa Kinoid dose 3 Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28

Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Whole study period ]

Secondary Outcome Measures :
  1. Antibody response [ Time Frame: Day 38 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00808262

Layout table for location information
South Africa
Durbanville Medi-Clinic
Cape Town, Cape, South Africa, 7550
Parexel Port Elizabeth
Port Elizabeth, Eastern Cape, South Africa
Farmovs Parexel
Bloemfontein, South Africa
Parexel George
George, South Africa
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pierre Vandepapeliere, MD, PhD Neovacs

Layout table for additonal information
Responsible Party: Pierre Vandepapeliere, CMO, Neovacs SA Identifier: NCT00808262     History of Changes
Other Study ID Numbers: TNF-K-001
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Neovacs:
crohn's disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases