A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014176) 


Tracking Information

Start Date  ICMJEJanuary 2007
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)		Part 1:Evaluate the dose response; Select SC induction regimen(s) of CNTO 148 (golimumab), based on safety and efficacy; Part 2:Evaluate the safety and efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical response at Week 6. [ Time Frame: Part I: Week 6, Part II: Week 6 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJE 
 (submitted: June 14, 2007)		Part 1:Evaluate the dose response; Select SC induction regimen(s) of CNTO 148 (golimumab), based on safety and efficacy; Part 2:Evaluate the safety and efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical response at Week 6.
Change HistoryComplete list of historical versions of study NCT00487539 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 21, 2007)		Evaluate the efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical remission, mucosal healing, improving disease-specific health-related quality of life at Week 6. [ Time Frame: Part II: Week 6 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: June 14, 2007)		Evaluate the efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical remission, mucosal healing, improving disease-specific health-related quality of life at Week 6.

Descriptive Information

Brief Title  ICMJEA Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014176)
Official Title  ICMJEA Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis.

Detailed Description

CNTO 148 (golimumab) is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. CNTO 148 (golimumab) may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of ulcerative colitis(UC).This study will assess the safety and effectiveness of subcutaneously (under the skin) administered CNTO 148 (golimumab) and determine if there is a reduction of signs and symptoms (such as diarrhea and rectal bleeding) in patients with active ulcerative colitis. The effect of subcutaneously (SC) administered CNTO 148 (golimumab) on the quality of life in patients with ulcerative colitis will also be assessed. About 676 patients will take part in the study at approximately 150 centers.Participation in the study will last for six weeks. At week 6, patients will be asked to participate in an additional 54-week maintenance study and a long-term extension study (CR014188) that will last approximately 3 years. If the patient chooses not to participate in the maintenance study, their participation in this study will extend 16 weeks after the last dose of study medication.There are two parts to this study. Part 1 is called "dose-ranging" and will enroll 176 patients. Patients enrolled in Part 1 will be equally assigned to subcutaneous (under the skin) injections at Week 0 of either placebo, or a total dose of CNTO 148 (golimumab), 100mg, 200mg, or 400mg followed by injections at Week 2 of either placebo, or total dose of CNTO 148 (golimumab) 50mg, 100mg, or 200mg, respectively.Part 2 of this study is called "dose confirming" and will enroll 500 patients. Patients will be equally assigned to the same doses as studied in Part 1 until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled patients will be equally assigned to one of the selected doses or placebo. This entire study is "blinded." This means that neither the patient nor the study doctor will know which treatment the patient received. The overall purpose of this trial is to determine if treatment with CNTO 148 (golimumab) is better than treatment with placebo in reducing a patient's ulcerative colitis signs and symptoms. Patients will receive multiple injections (under the skin) for a total dose of 0, 100, 200 or 400 mgCNTO 148 at Week 0 followed a total dose of 0, 50, 100 or 200 mg CNTO 148 (golimumab), respectively, at Week 2.

Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEUlcerative Colitis
Intervention  ICMJE
  • Biological: Placebo
    4 sc injections at week 0; 3 sc injections at week 2
  • Biological: Golimumab, placebo
    4 sc injection of 100 mg at Wk0 ; 2 sc injections of 100 mg at wk2; Placebo - 1 sc injection at wk 2
  • Biological: Golimumab, placebo
    2 sc injections of 100 mg at Wk0; 1 sc injection of 100mg at Wk2; placebo - 2 sc injections at Wk0; 2 sc injections at Wk2
  • Biological: Golimumab, placebo
    1 sc injection of 100mg at Wk0 and 50mg at Wk2; placebo - 3 sc injection at Wk0; 2 sc injections at Wk2
Study Arms / Comparison Groups
  • 001: Placebo Comparator
    Placebo 4 sc injections at week 0; 3 sc injections at week 2
    Intervention: Biological: Placebo
  • 004: Experimental
    Golimumab, placebo 4 sc injection of 100 mg at Wk0 ; 2 sc injections of 100 mg at wk2; Placebo - 1 sc injection at wk 2
    Intervention: Biological: Golimumab, placebo
  • 003: Experimental
    Golimumab, placebo 2 sc injections of 100 mg at Wk0; 1 sc injection of 100mg at Wk2; placebo - 2 sc injections at Wk0; 2 sc injections at Wk2
    Intervention: Biological: Golimumab, placebo
  • 002: Experimental
    Golimumab, placebo 1 sc injection of 100mg at Wk0 and 50mg at Wk2; placebo - 3 sc injection at Wk0; 2 sc injections at Wk2
    Intervention: Biological: Golimumab, placebo

Recruitment Information

Estimated Enrollment  ICMJE676
Estimated Completion DateJanuary 2011
Estimated Primary Completion DateOctober 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a biopsy consistent with the diagnosis of moderately to severely active ulcerative colitis (UC) prior to the beginning of the trial
  • Must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least 1 of the following therapies: oral 5-ASAs, oral corticosteroids, 6-mercaptopurine(6MP) and azathioprine (AZA )
  • Have or have had a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC)

Exclusion Criteria:

  • Have severe extensive ulcerative colitis that is likely to require a colectomy within 12 weeks of study entry
  • Have UC limited to the rectum only or to < 20 cm of the colon
  • Presence of a stoma
  • Presence or history of a fistula
  • Previous exposure to anti-TNF therapies
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:info1@veritasmedicine.com
Location Countries  ICMJEUnited States,   Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Japan,   Latvia,   Lithuania,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Sweden,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00487539
Responsible PartyAssoc Director Clinical Research, Centocor Inc.
Study ID Numbers  ICMJECR014176, C0524T17, EudraCT No: 2006-003398-28
Study Sponsor  ICMJECentocor, Inc.
Collaborators  ICMJESchering-Plough
Investigators  ICMJE
Study Director:Centocor, Inc. Clinical TrialCentocor, Inc.
Information Provided ByCentocor, Inc.