Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy

NCT00801125 | Withdrawn Phase 4

• 2 other identifiers: ELN51-309-503CD FACTOR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to demonstrate the safety, tolerability and clinical benefit of TYSABRI® (natalizumab) in patients with moderately to severely active Crohn's disease.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Proportion (%) achieving a clinical response at Week 12, defined as a reduction in the CDAI score from baseline (Week 0) of ≥ 70 points.

Secondary Outcomes (3)

• Proportion (%) achieving a clinical remission at each visit, defined as a CDAI score < 150

• Proportion achieving clinical response at Week 4 and Week 8

• Proportion achieving a ≥ 100 point decrease in baseline (Week 0) CDAI score at each visit

Interventions

natalizumab DRUG

Also known as: TYSABRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be able and willing to give written informed consent and to comply with the requirements of this study protocol;
• All patients must be CD TOUCH™ Prescribing Program enrolled;
• Male or female patients, ≥ 18 years of age;
• Patients with at least a 3-month history of CD;
• Patients with clinical evidence of active (symptomatic) CD based on clinical history and radiologic or endoscopic findings within the previous 36 months. Patients with active disease following surgical resection must have radiological or endoscopic confirmation of CD post-surgery;
• Patients must have evidence of active inflammation measured by CRP \>2.87mg/L at the Screening visit;
• Subjects must have a CDAI score ≥ 220 and ≤ 450 at Week 0;
• Female patients must utilize a highly effective method of birth control throughout the study and for 3 months after study completion, or female patients must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy);
• Initial treatment with an approved anti-TNF-α therapy, specifically infliximab, adalimumab, or certolizumab, who had either a primary or secondary treatment failure, or intolerance, to those agents;
• A primary treatment failure is defined as one of the following:
• The minimal requirement for a primary treatment failure to infliximab is defined as failure to respond to an induction regimen of 5 mg/kg at weeks 0, 2, and 6;
• The minimal requirement for a primary treatment failure to adalimumab is defined as failure to respond to an induction regimen of 160 mg at week 0, and 80 mg at week 2;
• The minimal requirement for a primary treatment failure to certolizumab is defined as a failure to respond to an induction regimen of 400 mg at weeks 0, 2, and 4;
• Secondary failures to a single anti-TNF-α agent is defined as:
• experienced clinical benefit in the opinion of the investigator, but lost that benefit over time or discontinued due to an adverse event, and / or;

You may not qualify if:

• Women of childbearing potential unless surgically sterile or using adequate contraception (IUD, oral or depot contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the last infusion of study drug (i.e., up to Week 20). Women using oral contraception must have started using it at least 2 months prior to enrollment;
• Women who are pregnant or breastfeeding;
• Prior treatment with TYSABRI® (natalizumab) (also referred to as Antegren™ in previous clinical trials);
• Symptoms suggestive of intestinal stricture or obstruction;
• History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin;
• Patients with a history of Listeria or human immunodeficiency virus (HIV) or a history of previously untreated TB;
• Patients who have had surgical bowel resections in the past 2 weeks or are planning any resection within 4 weeks of starting the study medication;
• Patients who do not meet any of the following criteria regarding baseline medications for CD (Please note that the term "Week 0" below refers to the exact day of the baseline visit):
• Baseline use of anti-tumor necrosis factor (anti-TNF-α) therapy, or previous use of all three approved agents, is not permitted;
• Baseline use of azathioprine (AZA), 6 mercaptopurine (6MP) / 6 thioguanine (6TG) / methotrexate (MTX) is not permitted;
• Baseline use of any other immunosuppressant (e.g., tacrolimus, cyclosporin, mycophenolate mofetil or leflunomide) is not permitted;
• Experimental agents must have been discontinued at least 4 weeks prior to Week 0, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer);
• Any baseline 5-Aminosalicylate (5 ASA) compounds or antibiotics are permitted and if used must be continued at a stable dose during the trial;
• Any baseline 5-Aminosalicylate (5 ASA) compounds or antibiotics must have been administered at a stable dose for a minimum of 4 weeks prior to Week 0;
• Any baseline use of budesonide must have been administered at a stable dose for a minimum of 2 weeks prior to Week 0;

Sponsors & Collaborators

• Biogen: lead
• Elan Pharmaceuticals: collaborator

MeSH Terms

Conditions

Crohn Disease

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Last Updated: June 16, 2016

Record last verified: 2009-01