An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03362736
• Date of registration: 30/11/2017
• Prospective Registration: No
• Primary sponsor: Janssen Research & Development, LLC
• Public title: An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease
• Scientific title: An Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: November 27, 2017
• Recruitment status: No longer available
• URL: https://clinicaltrials.gov/show/NCT03362736
• Study type: Expanded Access

Countries of recruitment

Brazil

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have Crohn's disease or fistulizing Crohn's disease of at least three months' duration
at the time of screening, with colitis, ileitis, or ileocolitis, confirmed at any time
in the past by radiography, histology, and/or endoscopy

- Have active Crohn's disease, defined as:

1. Baseline Crohn's disease activity index (CDAI) score of >= 220, and

2. At least one of the following: a.) Abnormal C-reactive protein (CRP) levels at
screening (defined by the participating physician/institution), b.) Fecal
calprotectin level greater than or equal to (>=) 250 milligram per kilogram
(mg/kg) at screening, c.) Endoscopy with evidence of active Crohn's disease
during the current disease flare (defined as ulcerations in the ileum and/or
colon). The endoscopy must have occurred within six months prior to baseline, d.)
Harvey Bradshaw index (HBI) >= 5

- Otherwise healthy on the basis of physical examination, medical history, vital signs,
and 12-lead electrocardiogram (ECG) performed at screening. If there are
abnormalities, they must be consistent with the underlying illness in the program
population. This determination must be recorded in the participant's source documents
and initialed by the physician

- Have failed treatment with conventional therapy (example, immunomodulators or
corticosteroids) and Tumor necrosis factor alpha (TNFalpha) antagonist therapy
(example, infliximab, adalimumab, certolizumab pegol, or their biosimilars), or are
intolerant to, or have a contraindication to these treatments. The failure of
conventional or biological therapy is defined as being a participant who, in the
opinion of the health care provider, have not responded adequately to the treatment
(that is, primary non-responders), or who lost response or became intolerant over time
to the treatment (that is, secondary non-responders) based on the physician's
judgement. The failure of conventional or TNF alpha antagonist therapy is defined as
being a participant who, in the opinion of the health care provider, did not respond
adequately to the treatment (that is, primary non-responders), or who lost response or
became intolerant over time to the treatment (that is, secondary non-responders) based
on the physician's judgement

- Meet one of the following conditions: a). Participant is female: Not of childbearing
potential or of childbearing potential and has a confirmed negative pregnancy test and
will be sexually inactive or agrees to practice a highly effective method of birth
control, including hormonal prescription oral contraceptives, contraceptive
injections, contraceptive patches, intrauterine devices, double-barrier method
(example, condoms, diaphragms, or cervical caps, with spermicidal foam, cream, or gel)
during and after participation in the early access program (EAP). Male condom and
female condom should not be used together (due to risk of failure with friction).
These restrictions apply through 20 weeks after receiving the last dose of
ustekinumab, b). Participant is male: either sexually inactive or agrees to practice a
highly effective method of birth control, such as a condom with spermicide during and
after participation in the EAP, and agrees not to donate sperm during and after
ustekinumab treatment. These restrictions apply through 20 weeks after receiving the
last dose of ustekinumab

Exclusion Criteria:

- Has complications of Crohn's disease such as symptomatic strictures or stenoses, short
gut syndrome, or any other manifestation that might be anticipated to require surgery,
and would possibly confound the ability to assess the safety of treatment with
ustekinumab

- Has had any kind of bowel resection within six months or any other intra-abdominal
surgery within three months prior to baseline

- Has evidence of current active infection, including untreated latent tuberculosis, or
a nodule suspicious for lung malignancy on screening or any other available chest
radiograph, unless definitively resolved surgically or by additional imaging and with
source document confirmation

- Has or is suspected to have an undrained abscess

- Enrolled in a clinical program of ustekinumab treatment of Crohn's disease in Brazil



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Ustekinumab

Secondary ID(s)

CNTO1275CRD3006

CR108395

Source(s) of Monetary Support

Please refer to primary and secondary sponsors