AzTrials
AzTrials

Crohn's DiseasePhase 4NCT00801125

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

A Phase 4 study testing natalizumab in people with Crohn's Disease, run by Biogen.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
natalizumab
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2008to May 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 21Show fewer
  • 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;
  • experienced clinical benefit in the opinion of the investigator, but are unable to be discontinued from concurrent oral corticosteroid therapy (i.e. ≥ 10 mg/day of prednisone/prednisolone or equivalent).
  • Secondary failures to two anti-TNF-α agents is defined as:
  • experienced clinical benefit to their initial anti-TNF-α agent in the opinion of the investigator, lost that benefit over time or discontinued due to an adverse event, and failed to regain clinical benefit following the administration of a standard induction protocol to a second anti-TNF-α agent; and/or;
  • experienced clinical benefit in the opinion of the investigator, but are unable to be discontinued from concurrent oral corticosteroid therapy (i.e. ≥ 10 mg/day of prednisone/prednisolone or equivalent).
  • Intolerance is defined as an inability to tolerate additional administration of an agent due to acute or delayed reactions, as defined by the investigator;
  • Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.

Who cannot join

  • 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;
Show all 27Show fewer
  • 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;
  • For oral steroids other than budesonide, patients must have been at a stable dose for a minimum of 2 weeks prior to Week 0;
  • Patients likely to require emergency surgery for persistent intestinal obstruction, bowel perforation, uncontrolled bleeding or abdominal abscess infection, and patients who have undergone bowel surgery, including resections, within the 3 months prior to Week 0;
  • Patients who have a colostomy, ileostomy, or colectomy with ileorectal anastomosis;
  • Ileal resections resulting in clinically relevant short bowel syndrome, in the opinion of the Investigator;
  • Patients who are receiving or have received nasogastric/nasoenteric tube feeding, an elemental diet, or total parenteral nutrition (TPN) within the 2 weeks prior to Week 0;
  • Patients with a chest X-ray suggestive of pulmonary infection at screening;
  • Patients with a history of clinically significant and/or persistent gastrointestinal disorder (other than CD), cardiovascular, renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers), or hematological illness;
  • Patients with any laboratory tests considered clinically significant at screening;
  • Patients whose symptoms are likely caused by factors other than inflammatory CD, including infection, irritable bowel syndrome (IBS), or ulcerative colitis (UC);
  • Patients who will be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason;
  • Patients who have do not have evidence of active inflammation.
  • Patients with active opportunistic infection or history of opportunistic infection in the last 6 month.

About this study

Official title: A Phase IV, Open-Label Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy

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
Being tested
natalizumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • natalizumabDrug

    Also called TYSABRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

  2. Proportion achieving clinical response at Week 4 and Week 8

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2010 (estimated)

Why it stopped: Study sponsor decided to withdraw the current study prior to enrollment of first participant.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801125
Sponsor's protocol ID
ELN51-309-503
Other IDs
CD FACTOR
Status last verified
Jan 2009
First submitted
1 Dec 2008
Last updated
16 Jun 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing natalizumab in people with Crohn's Disease, run by Biogen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion (%) achieving a clinical response at Week 12, defined as a reduction in the CDAI score from baseline (Week 0) of ≥ 70 points.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in