Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative Colitis

August 4, 2013 updated by: EMD Serono

A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose-finding Phase II Study of Subcutaneously Administered IFN-beta-1a in the Treatment of Patients With Moderately Active Ulcerative Colitis

The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in subjects with active ulcerative colitis (UC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderately active UC, defined as:

    • Diagnosis of UC documented by clinical, radiological and endoscopic or histological findings
    • Proctosigmoidoscopic diagnosis: at least left-sided disease; the extent of the colonic inflammation is to be more than 20 centimeter from the anal verge
    • A flare in disease activity considered moderate in according to the UCSS during the 14 days before initiation of study medication. Moderate disease is defined as a UCSS between 6 and 10 with a UCSS Physician's Global Assessment less than (<) 3 and a proctosigmoidoscopy score of 2 or 3
  • At least one previous flare-up of UC
  • Maintenance treatment with 5-aminosalicylic acid (5-ASA) at a stable dose for the management of UC is allowed, but not required. The daily dose of 5-ASA has to be stable for at least 4 weeks before Study Day 1 and has to be no more than 3.6 gram/day. This dose has to be maintained throughout the study. Corticosteroids will not be allowed during the study, with the exceptions of inhaled steroids and topical dermatological steroids
  • Age ≥18 years, of either sex
  • Adequate bone marrow reserve: white blood cells (WBC) greater than (>) 3.5*10^9 per liter (/L), neutrophils >1.5*10 ^9 /L, thrombocytes >100 *10^9 /L, hemoglobin >8.5 gram per deciliter (g/dL)
  • Female subjects are to be neither pregnant nor breast-feeding and has to lack childbearing potential, as will be defined by either being post-menopausal or surgically sterile or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or not pregnant which will be established by a negative serum or urinary Human chorionic gonadotrophin (hCG) test within 7 days before Study Day 1. A pregnancy test is not required if the subject was post-menopausal or surgically sterile
  • Willingness and ability to comply with the protocol for the duration of the study
  • Written informed consent, obtained before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to his or her future medical care

Exclusion Criteria:

  • Previous systemic treatment with interferons, immunosuppressive therapy (for example [e.g.], cyclosporin, azathioprine, 6-mercaptopurine) or other biological treatment (e.g. anti- Cluster of differentiation [CD] 4, anti-CD5, anti- Tumour necrosis factor [TNF]-alpha, Interleukin [IL]-10) in the 3 months before Study Day 1
  • Any other investigational drug or any experimental procedure in the 4 weeks before Study Day 1
  • More than three doses of rectally administered 5-ASA derivatives in the 2 weeks before Study Day 1
  • More than two doses of systemically or rectally administered corticosteroids in the 14 days before Study Day 1
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) or antibiotic therapy (e.g. metronidazole) in the 2 weeks before Study Day 1
  • Use of codeine, other narcotics, loperamide or opiates after the Screening visit or during the study
  • Stool examination positive for enteric pathogens, pathogenic ova, parasites, or Clostridium toxin at Screening
  • Need for emergency surgery (uncontrollable hemorrhage, persistent non-inflammatory intestinal obstruction - at the Investigator's discretion - or perforation), elective surgery during the study, or surgery in the 4 weeks before study entry
  • Inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase level >2 times the upper limit of the normal range
  • Inadequate renal function, defined by serum creatinine >2.0 milligram per deciliter (mg/dL)
  • Histopathological findings of high-grade dysplasia or history of cancer (except carcinoma in situ of the cervix or adequately treated basal cell or squamous cell carcinoma of the skin)
  • Known allergies to paracetamol or to any of the ingredients of the medicinal product (that is, the active substance, human serum albumin or mannitol)
  • Severe depressive disorder or suicidal ideation, or epilepsy with a history of seizures not adequately controlled by treatment
  • Known alcohol or drug abuse within the past 5 years
  • Other serious concurrent systemic disorders incompatible with the study (at the Investigator's discretion)
  • Severe active infection (at the Investigator's discretion)
  • Dependence on a liquid diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matching Placebo will be administered subcutaneously, three times a week up to Week 8.
Experimental: Interferon-beta-1a, 44 microgram
Drug: Interferon-beta-1a, 44 microgram
Interferon-beta-1a will be administered subcutaneously at a dose of 44 mcg, three times a week up to Week 8.
Other Names:
  • Rebif®
Experimental: Interferon-beta-1a, 66 microgram
Drug: Interferon-beta-1a, 66 microgram
Interferon-beta-1a will be administered subcutaneously at a dose of 66 mcg, three times a week up to Week 8.
Other Names:
  • Rebif®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with endoscopically confirmed remission
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with clinical remission
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure
Percentage of subjects with clinical remission at Week 8 and 12
Time Frame: Week 8 and 12
Week 8 and 12
Time to first occurrence of clinical remission
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure
Time to first occurrence of endoscopically confirmed remission
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure
Percentage of subjects with clinical remission two weeks after endoscopically confirmed remission
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure
Percentage of subjects with clinical response
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure
Time to first occurrence of clinical response
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure
Change from Baseline in Ulcerative Colitis Scoring System (UCSS) total score and sub-scores at Week 2, 4, 6, 8 and 12
Time Frame: Baseline, Week 2, 4, 6, 8 and 12
Baseline, Week 2, 4, 6, 8 and 12
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and sub-scores at Week 4, 8 and 12
Time Frame: Baseline, Week 4, 8 and 12
Baseline, Week 4, 8 and 12
Percentage of subjects with an increase in IBDQ score of at least 15 points
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure
Change from Baseline in C-reactive protein level at Week 2, 4, 8 and 12
Time Frame: Baseline, Week 2, 4, 8 and 12
Baseline, Week 2, 4, 8 and 12
Changes from Baseline in erythrocyte sedimentation rate at Week 2, 4, 8 and 12
Time Frame: Baseline, Week 2, 4, 8 and 12
Baseline, Week 2, 4, 8 and 12
Percentage of subjects with treatment failure
Time Frame: Baseline up to Week 12 or early withdrawal or treatment failure
Baseline up to Week 12 or early withdrawal or treatment failure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono

Collaborators

Merck Serono International SA

Investigators

  • Study Director: Claudia Pena Rossi, M.D., Merck Serono International SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria

March 14, 2006

First Posted (Estimate)

March 16, 2006

Study Record Updates

Last Update Posted (Estimate)

August 6, 2013

Last Update Submitted That Met QC Criteria

August 4, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe