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Phase 3
18 Years
65 Years
Not Enrolling
Both
Crohn's Disease

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Trial Information


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Richard Vensel McCloskey

Investigator Role:

Study Chair

Investigator Affiliation:

Centocor, Inc.

Authority:

United States: Federal Government

Study ID:

199/13447

NCT ID:

NCT00004941

Start Date:

July 1996

Completion Date:

July 1996

Related Keywords:

  • Crohn's Disease
  • Crohn's disease
  • gastrointestinal disorders
  • rare disease
  • Crohn Disease
  • Intestinal Fistula

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