Condition category
Digestive System
Date applied
08/09/2005
Date assigned
20/02/2006
Last edited
26/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Hommes

ORCID ID

Contact details

Academic Medical Center
Department of Gastroenterology
Room C2-330
Melbergdreef 9
Amsterdam
1105AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00267722

Protocol/serial number

291-412

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the clinical activity of two consecutive daily doses of 10 mcg/kg of visilizumab administered intravenously to patients with moderate to severe inflammatory, non-stricturing, non-penetrating forms of Crohn's disease

Ethics approval

Approved by the Medical Ethics Committee on 03/02/2005, (ref: 04/325)

Study design

Treatment, non-randomized, open label, uncontrolled, single group assignment, efficacy study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Crohn's disease

Intervention

Two consecutive daily doses of 10 mcg/kg of visilizumab administered intravenously. Taking of blood samples, endoscopy and biopsies.

Intervention type

Drug

Phase

Phase II

Drug names

Visilizumab

Primary outcome measures

To evaluate the clinical activity of two consecutive daily doses of 10 mcg/kg of visilizumab administered intravenously to patients with moderate to severe inflammatory, non-stricturing, non-penetrating forms of Crohn's disease

Secondary outcome measures

1. To evaluate the pharmacokinetics of two consecutive daily doses of visilizumab administered intravenously in this patient population
2. To determine the risk-benefit relationship of visilizumab in this patient population
3. To assess immunogenicity of visilizumab in this patient population
4. To evaluate the safety, tolerability, clinical activity, pharmacokinetics and immunogenicity of retreatment (if warranted) of two consecutive daily doses of 10 mcg/kg visilizumab in patients with moderate-to-severe inflammatory, non-stricturing, non-penetrating forms of Crohn's disease

Overall trial start date

01/10/2004

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female, 18 to 70 years of age
2. A diagnosis of moderate-to-severe inflammatory, non-stricturing, non-penetrating Crohn’s disease, defined as Crohn’s Disease Activity Index (CDAI) >/= 250, C-Reactive Protein (CRP) >/= Upper Limit of Normal (ULN) and endoscopic evidence of moderate-to-severe active inflammatory disease
3. Patients with reproductive potential who agree to use double-barrier methods of contraception during the study and for three months after receiving the study drug
4. Women of childbearing potential who have negative serum pregnancy test
5. Patients who have been tested negative for Clostridium difficile within three weeks prior to treatment with the study drug
6. Patients 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. Patients who have Epstein-Barr virus (EBV) Deoxyribonucleic Acid (DNA) titers up to 30,000 copies/ml

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. History of lymphoproliferative disorder or a prior malignancy within five years or current malignancies (excluding non-melanoma skin cancers or in situ carcinoma of the cervix that has been adequately treated)
2. Pregnant women or nursing mothers
3. Any of the following hematologic abnormalities: White Blood Cell (WBC) <2500 /mm^3, platelets <150,000 /mm^3, 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 six months prior to receiving the study drug
6. Serious infections, particularly those of viral etiology e.g. known active cytomegalovirus (CMV) colitis, and patients who have had a history of opportunistic infections within the past year
7. Active infections that require antibiotic therapy (not to include use of antibiotics to control Crohn’s disease)
8. Started, or have a dose change of, sulfasalazine, 5-aminosalicylic acid (5-ASA), or antibiotics, probiotics, or topical therapies for Crohn’s disease within two weeks prior to receiving the study drug
9. Serious infections that required intravenous (IV) antibiotic therapy or hospitalization within eight weeks prior to receiving the study drug
10. Had an increased dose in corticosteroid medication two weeks prior to receiving the study drug, is receiving IV steroids, or, is receiving a daily dose of >40 mg prednisone, >9 mg budesonide, or equivalent
11. Received a live vaccine within six weeks prior to receiving the study drug (patients may not receive a live vaccine during treatment or for 12 weeks after treatment with the study drug)
12. Received any monoclonal antibodies (including infliximab) or investigational agents or biologics within three months prior to receiving the study drug
13. Received cyclosporine or tacrolimus (FK506) within four weeks of receiving the study drug
14. Had a dose change of, or discontinued from, 6-mercaptopurine, azathioprine, or methotrexate within four weeks prior to receiving the study drug
15. Significant organ dysfunction, including cardiac, renal, liver, Central Nervous System (CNS), pulmonary, vascular, non-Crohn's disease-related gastrointestinal, endocrine, or metabolic (e.g. creatinine >1.6 mg/dl, alanineamino transferase [ALT] or aminotransferase [AST] > twice the Upper Limit of Normal [ULN], alkaline phosphatase >1.5 x ULN, history of myocardial infarction, congestive heart failure, or arrhythmias within six months prior to receiving the study drug)
16. Likely to require surgery in the next six months, such as those with clinically apparent abscesses or severely symptomatic stenoses
17. History of lymphoproliferative disorder
18. History of tuberculosis (TB) or other mycobacterial 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 Crohn’s disease (not including joint, skin, hepatic, and ocular inflammatory conditions that may be more typically associated with Crohn’s disease)
21. History of seizure with subtherapeutic blood levels of anticonvulsive medication (documented) within one week before study enrolment

Recruitment start date

01/10/2004

Recruitment end date

31/08/2007

Locations

Countries of recruitment

Germany, Netherlands, United States of America

Trial participating centre

Academic Medical Center
Amsterdam
1105AZ
Netherlands

Sponsor information

Organisation

PDL BioPharma Inc. (USA)

Sponsor details

34801 Campus Drive
Fremont
CA 94587
United States of America
mddyer@pdl.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Protein Design Labs Inc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes