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

ID: NCT03362736
Status: Available
Phase: N/A
Start Date: N/A
First Submitted: November 30, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Janssen Research & Development, LLC
Location: Brazil
Conditions: Crohn Disease
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Study Description

Brief Summary

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Crohn Disease

Drug: Ustekinumab
Other Names
CNTO1275
N/A

Tracking Information

First Submitted DateNovember 30, 2017
Last Update Posted DateFebruary 23, 2018
Start DateN/A
Completion DateN/A
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleAn Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease
Official TitleAn Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease
Brief Summary

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.

Detailed Description

Study TypeExpanded Access
Study PhaseN/A
Estimated Enrollment
0
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Crohn Disease
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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 Names
CNTO1275
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Available
Enrollment0
Completion DateN/A
Eligibility 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Brazil

Administrative Information

NCT Number:NCT03362736
Other Study ID Numbers
CR108395
CNTO1275CRD3006
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Janssen Research & Development, LLC
Collaborators
Not Available
Investigators
Study Director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC