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Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004941
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: April 2000

February 24, 2000
June 23, 2005
July 1996
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Complete list of historical versions of study NCT00004941 on ClinicalTrials.gov Archive Site
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Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
Not Provided

OBJECTIVES:

I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in closure of enterocutaneous fistulae in patients with Crohn's disease.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to investigational site and number of fistulae (single vs multiple).

Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients receive an infusion of placebo on day 1 of weeks 0, 2, and 6.

Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Crohn's Disease
Drug: monoclonal antibody cA2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
July 1996
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PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Crohn's disease of at least 3 months duration confirmed by radiography or endoscopy

Single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration

All fistulae separate and distinctly identifiable

No local complications of Crohn's disease such as strictures or abscesses

--Prior/Concurrent Therapy--

Biologic therapy:

  • No prior chimeric monoclonal antibody (cA2)
  • At least 3 months since treatment with other therapeutic agent targeted at reducing tumor necrosis factor (e.g., pentoxifylline or thalidomide)
  • At least 4 weeks since cyclosporine

Chemotherapy:

  • Concurrent methotrexate permitted if treatment began at least 3 months prior to enrollment, dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period
  • Otherwise, no methotrexate within 4 weeks prior to enrollment

Concurrent 6-mercaptopurine or azathioprine permitted if treatment began at least 6 months prior to enrollment, dose has been stable for at least 8 weeks prior to enrollment, and remains stable throughout study period Otherwise, no 6-mercaptopurine or azathioprine within 4 weeks prior to enrollment

Endocrine therapy:

  • Concurrent corticosteroids (e.g., oral prednisone) permitted if dose has been stable for at least 3 weeks prior to enrollment, does not exceed 40 mg/kg, and remains stable throughout study period (dosage may be tapered after 6 weeks for some patients)
  • Otherwise, no corticosteroids within 4 weeks prior to enrollment

Other:

  • Concurrent antibiotics or aminosalicylates for Crohn's disease permitted if dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period
  • Otherwise, no antibiotics or aminosalicylates within 4 weeks prior to enrollment
  • At least 3 months since investigational drugs

--Patient Characteristics--

Hematopoietic:

  • WBC at least 3,500/mm3
  • Neutrophil count at least 1,500/mm3
  • Lymphocyte count at least 500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 8.5 g/dL
  • No severe, progressive, or uncontrolled hematologic disease

Hepatic:

  • SGOT no greater than 3 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 3 times ULN
  • No severe, progressive, or uncontrolled hepatic disease

Renal:

  • Creatinine no greater than 1.7 mg/dL
  • No severe, progressive, or uncontrolled renal disease

Cardiovascular: No severe, progressive, or uncontrolled cardiac disease

Pulmonary: No severe, progressive, or uncontrolled pulmonary disease

Neurologic: No severe, progressive, or uncontrolled neurologic or cerebral disease

Other:

  • Negative pregnancy test required and no planned pregnancy within 7.5 months following first infusion
  • Effective contraception required of fertile patients during and for 6 months after study
  • No severe, progressive, or uncontrolled endocrine disease
  • No serious infections (e.g., hepatitis, pneumonia, pyelonephritis) within prior 3 months
  • No history of opportunistic infections (e.g., herpes zoster) within 2 months
  • No allergy to murine proteins
  • No active cytomegalovirus, Pneumocystis carinii, or drug resistant atypical mycobacterial infections
  • No recent drug or alcohol abuse
  • No HIV infection, ARC (AIDS-related complex) or AIDS
  • Total parenteral nutrition or tube feeding not permitted
  • No prior or concurrent malignancy within 5 years
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004941
199/13447, CENTOCOR-C0168T20, CENTOCOR-FDR001276
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FDA Office of Orphan Products Development
Centocor, Inc.
Study Chair: Richard Vensel McCloskey Centocor, Inc.
FDA Office of Orphan Products Development
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP