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

Study Purpose

The purpose of this program is to provide early access to ustekinumab where it is commercially unavailable for the treatment of participants with moderately to severely active Crohn's disease who have failed treatment with conventional Crohn's disease therapy (example, immunomodulators or corticosteroids) and Tumor Necrosis Factor alpha (TNF alpha) antagonist therapy (e.g., infliximab, adalimumab, certolizumab pegol, or their biosimilars), or who are intolerant to, or have a contraindication to these treatments. During the course of this early access program (EAP), through the reporting of serious adverse events (SAEs) and non-serious adverse drug reactions (ADRs) by participating physicians, information on the safety and tolerability of ustekinumab will be captured.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Expanded Access
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03362736

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Janssen Research & Development, LLC

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Available
Countries Brazil

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn Disease
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Nossa Senhora Das Gracas, Curitiba, Brazil

Status

Address

Hospital Nossa Senhora Das Gracas

Curitiba, , 80810-040

Site Contact

844-434-4210

Juiz De Fora, Brazil

Status

Address

Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida

Juiz De Fora, , 36010-560

Site Contact

844-434-4210

Instituto do Aparelho Digestivo, Porto Alegre, Brazil

Status

Address

Instituto do Aparelho Digestivo

Porto Alegre, , 90560-002

Site Contact

844-434-4210

Ribeirão Preto, Brazil

Status

Address

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Ribeirão Preto, , 14098-900

Site Contact

844-434-4210

Rio De Janeiro, Brazil

Status

Address

UFRJ-Hospital Universitário Clementino Fraga Filho

Rio De Janeiro, , 20050-902

Site Contact

844-434-4210

Hospital Copa D'Or, Rio De Janeiro, Brazil

Status

Address

Hospital Copa D'Or

Rio De Janeiro, , CEP: 22031-010

Site Contact

844-434-4210

São Paulo, Brazil

Status

Address

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, , 01246903

Site Contact

844-434-4210

São Paulo, Brazil

Status

Address

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, , 05652-900

Site Contact

844-434-4210

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