Active Ulcerative ColitisPhase 2NCT00616434
A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
A Phase 2 study testing BG9418 (Interferon beta-1a) in people with Active Ulcerative Colitis, run by Biogen at 35 sites in 7 countries.
Trial summary
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Active Ulcerative Colitis
- What is being tested?
- BG9418 (Interferon beta-1a)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 35 sitesin 7 countries
- Study dates
- May 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of ulcerative colitis (UC) for ≥6 months
- 20 cm active disease at Screening endoscopy
- Must have active UC with a Mayo Score/Disease Activity Index (DAI) of 6 to 13 points and moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) despite prior or concomitant treatment
- Colonoscopy within past 5 years for extent of disease and to exclude polyps
- For subjects with UC for more than 10 years, colonoscopy with appropriate biopsies within 1 year prior to Screening to exclude dysplasia and neoplasia.
- Must be willing and able to practice effective birth control during the study and for 1 month after the last dose of study treatment.
Who cannot join
- Diagnosis of indeterminate colitis or Crohn's disease
- Need for imminent surgery
- Diagnosis of primary sclerosing cholangitis or toxic megacolon
- Hemoglobin ≤9 g/dL
- White blood cell count < 3500 cells/mm^3
- Lymphocyte count <1000 cells/µL
Show all 18Show fewer
- Platelet count <100,000 cells/µL
- Female subjects who are pregnant or who wish to become pregnant during the study, or who are lactating
- Known symptomatic colonic stricture
- Stool cultures positive for enteric infection
- History of malignant disease
- History of major abdominal surgery (e.g., gastrectomy) within past 5 years
- History of small bowel or colonic obstruction or resection
- History of drug or alcohol abuse (as defined by the Investigator) within 2 years prior to Screening
- Use of anti-diarrheal agents during the screening period
- Previous participation in this study
- Previous treatment with interferon beta or other interferon products
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
Russia9 sites
Investigator
Kazan'
Investigator
Krasnodar
Investigator
Lipetsk
Investigator
Moscow
Investigator
Nizhny Novgorod
Investigator
Rostov-on-Don
Investigator
Saint Petersburg
Investigator
Saratov
Investiator
Yaroslavl
Czechia6 sites
Investigator
Hradec Králové
Investigator
Ostrava
Investigator
Parbudice
Investigator
Prague
Investigator
Slaný
Investigator
Teplice
Poland6 sites
Investigator
Lublin
Investigator
Pruszków
Investigator
Sopot
Investigator
Torun
Investigator
Warsaw
Investigator
Wroclaw
United States5 sites
Investigator
Birmingham, Alabama, 35294
Investigator
Bristol, Connecticut, 06010
Investigator
Lakewood, Colorado, 80215
Investigator
Oklahoma City, Oklahoma, 73104
Investigator
Wellesley Hills, Massachusetts, 02481
Hungary4 sites
Investigator
Budapest
Investigator
Eger
Investigator
Szeged
Investigator
Székesfehérvár
Canada3 sites
Investigator
Calgary, Alberta, T2N4N1
Investigator
Kelowna, British Columbia, V1Y 2H4
Investigator
Winnipeg, Manitoba, R3A1R9
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Avonex® in Subjects With Moderate to Severe Ulcerative Colitis
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.
- Conditions
- Active Ulcerative Colitis
- Being tested
- BG9418 (Interferon beta-1a), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG9418 (Interferon beta-1a)Drug
Also called Avonex®
Avonex IM injection, self-administered per protocol
PlaceboDrug
Placebo IM injection, self-administered per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Interferon beta-1a | Experimental | Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks Receives: Drug: BG9418 (Interferon beta-1a) |
| Placebo | Placebo comparator | Placebo IM injection twice weekly for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Clinical Response
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
Measured: Baseline and Week 8
Secondary outcomes (2)
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE, can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AE's were analyzed based on the principle of treatment emergence. An AE was regarded as treatment-emergent if it was not present prior to receiving the first injection but subsequently appeared, or if it was present prior to receiving the first injection and subsequently worsened in severity.
Measured: Up to 16 weeks
Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8
The SCCAI measures disease activity as defined by both participants and examiners and includes the following 13 items: general well-being, abdominal pain, bowel frequency, stool consistency, bleeding, anorexia, nausea or vomiting, abdominal tenderness, extra-intestinal complications (eye, mouth, joint, skin), temperature, sigmoidoscopic assessment, nocturnal bowel movements, and urgency of defecation. Scores range from 0 to 19 points, and scores <2.5 have been shown to correlate with Patient-Defined Remission, and a decrease of >1.5 points from Baseline correlates with Patient-Defined Significant Improvement. Baseline is defined as the mean of the screening and visit 1 scores.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Active Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Who is masked
- Participant, Care provider
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616434
- Sponsor's protocol ID
- 108UC201
- Other IDs
- 2007-004867-22
- Status last verified
- Jul 2014
- First submitted
- 5 Feb 2008
- Last updated
- 13 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Avonex® in Subjects With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00616434
- Acronym / sponsor ID
- 108UC201
- Conditions
- Active Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 13 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon beta-1a | Experimental | Drug: BG9418 (Interferon beta-1a)Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo IM injection twice weekly for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Established diagnosis of ulcerative colitis (UC) for ≥6 months
- Must have active UC with a Mayo Score/Disease Activity Index (DAI) of 6 to 13 points and moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) despite prior or concomitant treatment
- Colonoscopy within past 5 years for extent of disease and to exclude polyps
- For subjects with UC for more than 10 years, colonoscopy with appropriate biopsies within 1 year prior to Screening to exclude dysplasia and neoplasia.
- Must be willing and able to practice effective birth control during the study and for 1 month after the last dose of study treatment.
Key exclusion criteria (18 listed)
- Diagnosis of indeterminate colitis or Crohn's disease
- Need for imminent surgery
- Diagnosis of primary sclerosing cholangitis or toxic megacolon
- Hemoglobin ≤9 g/dL
- White blood cell count < 3500 cells/mm^3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG9418 (Interferon beta-1a)Also: Avonex®Avonex IM injection, self-administered per protocol | Drug | Interferon beta-1a |
| PlaceboPlacebo IM injection, self-administered per protocol. | Drug | Placebo |
Primary outcome
Percentage of Participants With a Clinical Response
Time frame: Baseline and Week 8
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
2 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Up to 16 weeks
Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8
Time frame: Baseline and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BG9418 (Interferon beta-1a) in people with Active Ulcerative Colitis, run by Biogen at 35 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 6 inclusion and 18 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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Russia, Czechia, Poland, United States, Hungary 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?
Yes. Results are posted in the registry (first posted 13 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With a Clinical Response (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2014.