EUCTR2010-022760-12-IT
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI
DrugsStelara
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag International N.V.
- Enrollment
- 1281
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Have received study agent at Week 0 in study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 CDAI score evaluation.
- •2\. Be able to complete the Week 0 visit in study CNTO1275CRD3003 within 4 days of the Week 8 visit in study CNTO1275CRD3001 or CNTO1275CRD3002\. At the discretion of the investigator, the window may be extended to 8 days to allow appropriate treatment and/or recovery of nonserious infections (eg, acute upper respiratory tract infection, simple urinary tract infection).
- •3\. Be able and willing to adhere to the study visit schedule and comply with other protocol requirements
- •4\. Be capable of providing informed consent, which must be obtained prior to any study\-related procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 1235
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 75
Exclusion Criteria
- •1\. Had any of the following changes to their concomitant medications due to Crohn’s disease (ie, lack of efficacy) since Week 0 of studies CNTO1275CRD3001 and CNTO1275CRD3002
- •a. Increase in physician\-prescribed daily dose of oral corticosteroids of more than 5 mg or more of prednisone (or equivalent increase in prednisone\-equivalent dose of other corticosteroids),
- •b. Initiation of oral budesonide or increase in daily dose
- •c. Initiation of parenteral, and oral corticosteroids for Crohn’s disease, except for dose equivalent substitutions among oral corticosteroids
- •d. Initiation or increased physician\-prescribed daily dose of methotrexate (MTX), 6\-MP, or azathioprine (AZA), except for dose equivalent substitutions
- •2\. Initiated a protocol prohibited medication since Week 0 of studies CNTO1275CRD3001 and CNTO1275CRD3002:
- •a. Immune suppressing immunomodulatory agents other than 6\-MP/AZA or MTX (including but not limited to 6\-TG, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil)
- •b. Immunosuppressant biologic agents (including but not limited to TNF\-antagonists, natalizumab, abatacept, commercial ustekinumab)
- •c. Experimental Crohn’s disease medications (including but not limited to thalidomide, briakinumab, vedolizumab, traficet, AMG\-827\)
- •3\. Underwent a Crohn’s disease related surgery since Week 0 of induction study CNTO1275CRD3001 or CNTO1275CRD3002\. Seton placement and recent cutaneous and perianal abscesses which have been drained and adequately treated at least 3 weeks prior to receiving baseline study agent are not exclusionary provided that there is no anticipated need for any further surgery
Outcomes
Primary Outcomes
Not specified
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