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Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01647516
Recruitment Status : Active, not recruiting
First Posted : July 23, 2012
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: RPC1063 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : December 12, 2012
Actual Primary Completion Date : October 8, 2014
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: RPC1063 Low Dose
oral, low dose, daily for 32 weeks
Drug: RPC1063
Experimental: RPC1063 High Dose
oral, high dose, daily for 32 weeks
Drug: RPC1063
Placebo Comparator: Placebo
oral, one capsule, daily for 32 weeks
Drug: placebo



Primary Outcome Measures :
  1. Remission [ Time Frame: Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ulcerative colitis (UC) confirmed on endoscopy
  • Moderately to severely active UC (Mayo score 6-12)

Exclusion Criteria:

  • Current use of anti-TNF agents

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): NCT01647516


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Sponsors and Collaborators
Celgene

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01647516     History of Changes
Other Study ID Numbers: RPC01-202
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases