A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

Eligible patients will be considered for inclusion in this study if they meet all of the following criteria:

1) Male or female, 18 to 70 years of age

2) A diagnosis of CD and at least one documented external, draining, perianal fistula

3) Patients with reproductive potential who agree to use double-barrier methods of contraception during the study and for 3 months after receiving study drug

4) Women of childbearing potential who have a negative serum pregnancy test at baseline screening

5) Who have tested negative for Clostridium difficile within 3 weeks prior to treatment with study drug

6) Who are capable of understanding the purpose and risks of the study and who provide signed and dated informed consent and an authorization to use protected health information (US sites only)

7) Who have EBV DNA titers up to 30, 000 copies/mL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be ineligible for this study if they meet any one of the following criteria:

1) History of lymphoproliferative disorder or a prior malignancy within 5 years or current malignancies (excluding nonmelanoma skin cancers or carcinoma in situ of the cervix that has been adequately treated)

2) Pregnant women or nursing mothers

3) Any of the following hematologic abnormalities: WBC < 2500/mm3; platelets < 150,000/mm3; hemoglobin < 10 g/dL

4) Serologic evidence of infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV, HCV)

5) Presence of obstructive symptoms, confirmed by endoscopy showing an impassable stricture or computed tomography (CT) or barium studies showing stricture with prestenotic bowel dilation, within 6 months prior to receiving study drug

6) Likely to require surgery in the next 6 months, such as those with clinically apparent abscesses or severely symptomatic stenoses (patients with fistula abscesses and/or setons at screen may be eligible for study entry if abscesses can be drained before patients receive study drug)

7) Serious infections, particularly those of viral etiology, eg, active CMV colitis, and who have history of opportunistic infections within the past year

8) Active infections that require antibiotic therapy (not to include use of antibiotics to manage CD)

9) Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks prior to receiving study drug

10) Started, or have had a dose change of, sulfasalazine, 5-aminosalicylic acid (5-ASA), or antibiotics, probiotics or topical therapies for CD within 2 weeks prior to receiving study drug

11) Had an increased dose in corticosteroid medication within 2 weeks prior to receiving study drug; is receiving IV steroids; or, is receiving a daily dose of > 40 mg prednisone, > 9 mg budesonide, or equivalent

12) Received a live vaccine within 6 weeks prior to receiving study drug (patients may not receive a live vaccine during treatment or for 12 weeks after treatment with study drug)

13) Received any monoclonal antibodies (including infliximab) or investigational agents or biologics within 3 months prior to receiving study drug

14) Received cyclosporine or tacrolimus (FK506) within 4 weeks of receiving study drug

15) Had a dose change of or discontinued from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks prior to receiving study drug

16) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, non-CD-related gastrointestinal, endocrine, or metabolic (eg, creatinine >=1.6 mg/dL; ALT or AST >= twice the upper limit of normal (ULN); alkaline phosphatase >= 1.5 X ULN; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry).

17) History of lymphoproliferative disorder

18) History of tuberculosis (TB) or other mycobacteria infection, or chest x-ray positive for previous TB infection

19) History of thrombophlebitis or pulmonary embolus

20) Histories of immune deficiency or autoimmune disorders other than CD (not including joint, skin, hepatic, and ocular inflammatory conditions that may be components of CD)

21) History of seizure with subtherapeutic blood levels of anticonvulsive medications (documented) within one week before study enrollment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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