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Ulcerative ColitisPhase 2NCT00303381

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

A Phase 2 study testing Interferon-beta-1a, 44 microgram and Interferon-beta-1a, 66 microgram in people with Ulcerative Colitis, run by EMD Serono at 7 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Interferon-beta-1a, 44 microgram and Interferon-beta-1a, 66 microgram
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
7 sitesin 7 countries
Study dates
Dec 2001to Jan 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 7 countries.

7 sites in 7 countries

Germany1 site

  • Research Site

    Munich

Other trials in Germany

Israel1 site

  • Research Site

    Ness Ziona

Other trials in Israel

Netherlands1 site

  • Research Site

    The Hague

Other trials in Netherlands

Singapore1 site

  • Research Site

    Singapore

Other trials in Singapore

Sweden1 site

  • Research Site

    Solna

Other trials in Sweden

Switzerland1 site

  • Research Site

    Zug

Other trials in Switzerland

United Kingdom1 site

  • Research Site

    Feltham

Other trials in United Kingdom

About this study

Official title: 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).

Being tested
Interferon-beta-1a, 44 microgram, Placebo, Interferon-beta-1a, 66 microgram
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon-beta-1a, 44 microgramDrug

    Also called Rebif®

    Interferon-beta-1a will be administered subcutaneously at a dose of 44 mcg, three times a week up to Week 8.

  • PlaceboDrug

    Matching Placebo will be administered subcutaneously, three times a week up to Week 8.

  • Interferon-beta-1a, 66 microgramDrug

    Also called Rebif®

    Interferon-beta-1a will be administered subcutaneously at a dose of 66 mcg, three times a week up to Week 8.

Study groups in NCT00303381
Study groupRoleWhat they receive
Interferon-beta-1a, 44 microgramExperimentalNot described
Receives: Drug: Interferon-beta-1a, 44 microgram
Interferon-beta-1a, 66 microgramExperimentalNot described
Receives: Drug: Interferon-beta-1a, 66 microgram
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with endoscopically confirmed remission

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

Secondary outcomes (13)

  1. Percentage of subjects with clinical remission

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

  2. Percentage of subjects with clinical remission at Week 8 and 12

    Measured: Week 8 and 12

  3. Time to first occurrence of clinical remission

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

  4. Time to first occurrence of endoscopically confirmed remission

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

  5. Percentage of subjects with clinical remission two weeks after endoscopically confirmed remission

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

  6. Percentage of subjects with clinical response

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

  7. Time to first occurrence of clinical response

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

  8. Change from Baseline in Ulcerative Colitis Scoring System (UCSS) total score and sub-scores at Week 2, 4, 6, 8 and 12

    Measured: Baseline, Week 2, 4, 6, 8 and 12

  9. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score and sub-scores at Week 4, 8 and 12

    Measured: Baseline, Week 4, 8 and 12

  10. Percentage of subjects with an increase in IBDQ score of at least 15 points

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

  11. Change from Baseline in C-reactive protein level at Week 2, 4, 8 and 12

    Measured: Baseline, Week 2, 4, 8 and 12

  12. Changes from Baseline in erythrocyte sedimentation rate at Week 2, 4, 8 and 12

    Measured: Baseline, Week 2, 4, 8 and 12

  13. Percentage of subjects with treatment failure

    Measured: Baseline up to Week 12 or early withdrawal or treatment failure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2006 (estimated)
  2. Study startDec 2001
  3. Primary completionJan 2003
  4. Study completionJan 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303381
Sponsor's protocol ID
22648
Status last verified
Aug 2013
First submitted
14 Mar 2006
Last updated
6 Aug 2013
Results posted
No

Publications

  • Pena-Rossi C, Schreiber S, Golubovic G, Mertz-Nielsen A, Panes J, Rachmilewitz D, Shieh MJ, Simanenkov VI, Stanton D, Graffner H. Clinical trial: a multicentre, randomized, double-blind, placebo-controlled, dose-finding, phase II study of subcutaneous interferon-beta-la in moderately active ulcerative colitis. Aliment Pharmacol Ther. 2008 Sep 15;28(6):758-67. doi: 10.1111/j.1365-2036.2008.03778.x.

    PubMed 19145731

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interferon-beta-1a, 44 microgram and Interferon-beta-1a, 66 microgram in people with Ulcerative Colitis, run by EMD Serono at 7 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Israel, Netherlands, Singapore, Sweden and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with endoscopically confirmed remission (time frame: Baseline up to Week 12 or early withdrawal or treatment failure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303381, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2013.

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