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Trial record 4 of 17 for:    STELARA Crohn's

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

Expanded access is currently available for this treatment.
Verified November 2017 by Janssen Research & Development, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT03362736
First Posted: December 5, 2017
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  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.

Condition Intervention
Crohn Disease Drug: Ustekinumab

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Intervention Details:
    Drug: Ustekinumab
    All participants will receive a single intravenous (IV) tiered dose of ustekinumab based on body weight at Week 0 (participants less than or equal to [<=] 55 kilogram [kg] will receive 260 milligram [mg] ustekinumab; > 55 kg to <= 85 kg will receive 390 mg ustekinumab; and > 85 kg will receive 520 mg ustekinumab infusion) during induction period. After the IV induction dose, all participants will receive the first maintenance dose of 90 mg ustekinumab subcutaneous (SC) injection 8 weeks later (Week 8). The participants with adequate response based on the physician's judgement will be subsequently treated with 90 mg ustekinumab SC injection with every 12 weeks through Week 80 and participants with an inadequate response to ustekinumab dosing every 12 weeks based on the physician's judgement will be subsequently treated with 90 mg of ustekinumab every 8 weeks through Week 80.
    Other Name: CNTO1275
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362736


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Brazil
Hospital Nossa Senhora Das Gracas
Curitiba, Brazil, 80810-040
Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida
Juiz De Fora, Brazil, 36010-560
Instituto do Aparelho Digestivo
Porto Alegre, Brazil, 90560-002
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, Brazil, 14098-900
UFRJ-Hospital Universitário Clementino Fraga Filho
Rio De Janeiro, Brazil, 20050-902
Hospital Copa D'Or
Rio De Janeiro, Brazil, CEP: 22031-010
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil, 01246903
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil, 05652-900
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03362736     History of Changes
Other Study ID Numbers: CR108395
CNTO1275CRD3006 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: November 30, 2017
First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents