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

Sponsor:	Centocor, Inc.
Collaborator:	Schering-Plough
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00487539

Purpose

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

Condition	Intervention	Phase
Ulcerative Colitis	Biological: Placebo Biological: Golimumab, placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Golimumab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	1065
Study Start Date:	August 2007
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 001 Placebo 4 sc injections at week 0; 3 sc injections at week 2	Biological: Placebo 4 sc injections at week 0; 3 sc injections at week 2
Experimental: 004 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 4 sc injection of 100 mg at Wk0 ; 2 sc injections of 100 mg at wk2; Placebo - 1 sc injection at wk 2
Experimental: 003 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 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
Experimental: 002 Golimumab, placebo 1 sc injection of 100mg at Wk0 and 50mg at Wk2; placebo - 3 sc injection 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487539

Sponsors and Collaborators

Centocor, Inc.

Schering-Plough

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

No publications provided

Responsible Party:	Assoc Director Clinical Research, Centocor Inc.
ClinicalTrials.gov Identifier:	NCT00487539 History of Changes
Other Study ID Numbers:	CR014176, C0524T17, EudraCT No: 2006-003398-28
Study First Received:	June 14, 2007
Last Updated:	March 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Ulcerative Colitis
injection

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012