Ulcerative ColitisPhase 2NCT00048347
Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis
A Phase 2 study testing AVONEX in people with Ulcerative Colitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of the drug interferon-beta1a (AVONEX) in treating ulcerative colitis and examine the drug's effect on the immune system. People with ulcerative colitis have increased amounts of inflammatory chemicals (cytokines) made by immune cells in the lining of the colon. 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?
- AVONEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old or greater.
- Diagnosis of ulcerative colitis for at least 4 months based on endoscopic appearance or radiographic distribution of disease and corroborated with histopathology (especially the absence of granulomata).
- Presence of current active disease as defined by a Simple Clinical Colitis Activity Index of greater than or equal to 5 (for either of the two measurements done during the Screening Phase and that the second measurement is within 50 percent of the value of the first) who may or may not have the presence of one of the following: current corticosteroid- dependence for disease treatment, disease refractory to corticosteroids, or history of intolerance to treatment with corticosteroids (for criterion of co-administered corticosteroid dose see below).
- Corticosteroid-dependence is defined as relapse of ulcerative colitis within 60 days of completing a course of corticosteroid treatment, or during corticosteroid tapering at doses greater than or equal to 10 mg prednisone/day (or equivalent), or within three months following corticosteroid tapering while receiving a steroid dose of greater than or equal to 10 mg prednisone/day (or equivalent).
- If currently receiving medication for ulcerative colitis, patients may be on a stable regimen of one or a combination of the following drug doses and durations:
- Corticosteroids (less than or equal to 25 mg Prednisone/d or Prednisone equivalent) is greater than or equal to 4 weeks;
Show all 14Show fewer
- 5-ASA/Sulfasalazine is greater than or equal to 4 weeks;
- Azathioprine/6-MP/thioguanine is greater than or equal to 12 weeks. (Note: Patients receiving azathioprine/6-MP/thioguanine must have been on a stable dose of this medication for greater than or equal to 8 weeks before randomization);
- Probiotics (live bacterial dietary supplements) greater than or equal to 4 weeks;
- Prebiotics (dietary supplements to produce biologically active substances) greater than or equal to 4 weeks.
- 5. Use of barrier or hormonal methods of birth control for female subjects who are not surgically sterile or postmenopausal.
- 6. Negative serum beta-hCG for women of child-bearing potential (women who are not surgically sterile or postmenopausal) to exclude early unnoticed pregnancy.
- 7. Negative results on stool examination for culture of enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, E. coli O157/H7), Clostridium difficile toxin assay, enteric parasites and their ova (including Giardia and Cryptosporidia).
- 8. Thyroid function test and TSH level within establish normal range set by the Clinical Center.
Who cannot join
- Inability to meet any of the above inclusion criteria.
- Use of any of the following medications within the specified time period prior to the first dose of interferon-beta or at any time during the study:
- Non-steroidal anti-inflammatory agents (including COX-2 inhibitors), - 1 week
- Corticosteroids (greater than 25 mg Prednisone/d or Prednisone equivalent), Methotrexate, Cyclosporin, Tacrolimus, Thalidomide, or Mycophenolate mofetil - 4 weeks
- Monoclonal antibodies to TNF alpha or any Other Biologic (cytokine, anti-cytokine, or integrin-based therapy, for instance) - 4 months
- Any experimental agent - 1 month
Show all 31Show fewer
- Concomitant use of any of the following drugs: isoniazid, iproniazid, dantrolene, ticrynafen (tienilic acid), ibufenac, bromfenac, benoxaprofen, zileutan, nicotinic acid, trovafloxacin, perhexiline, dilevavol, labetalol, pemoline, felbamate, tolcapone, diclofenac, AIDS drugs (HIV+ subjects are excluded anyway), and troglitozone.
- History of colectomy, partial colectomy, current ostomy, or pouchitis.
- Presence of significant electrocardiogram abnormalities including QT(c) greater than or equal to 0.48 sec, Mobitz type II second degree or third degree atrioventricular block, left bundle branch block or right bundle branch block accompanied by any fascicular block, changes consistent with acute ischemia or pericarditis.
- Presence of a diagnosis of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, or colitis attributable to infection. This determination may require use of clinical, endoscopic, and histologic data.
- Presence of Cushing's syndrome.
- Presence of current active bowel obstruction, intestinal perforation, significant GI hemorrhage, known presence of high grade stricture, history of toxic megacolon, history of colonic epithelium high-grade dysplasia or a dysplasia-associated lesion or mass that does not resemble an adenoma (that is a mass lesion, stricture, or broad-based tumor).
- Anticipation that surgery may be required to treat the ulcerative colitis within 3 months of study entry.
- HIV positivity or signs and symptoms consistent with HIV infection.
- Acute systemic or intestinal infection requiring antibiotics.
- Active hepatitis B or C.
- Decompensated liver disease (Childs-Pugh class B or C).
- Hematocrit less than 30 percent
- Platelet count 120,000 less than or greater than 850,000
- PT INR greater than 1.3 or PTT prolonged by greater than 3 seconds
- Serum creatinine or BUN greater than 1.5 times the upper limit of normal (ULN)
- ALT (SGPT) or AST (SGOT) greater than 2 times the ULN
- Total bilirubin greater than 1.25 times the ULN
- Alkaline phosphatase greater than 1.5 times the ULN.
- Pregnancy or nursing (for women).
- History of cancer (other than resected cutaneous basal or squamous cell carcinoma and in situ cervical cancer) with less than 5 years' documentation of a disease-free state.
- History of a myocardial infarction within the last 12 months.
- Any other condition that in the investigator's opinion places the patient at undue risk by participating in the study. This includes but is not limited to: psoriasis, thyroid disease, myasthenia gravis, lupus erythematosus, rheumatoid arthritis, Raynaud's disease, autoimmune hepatitis, C1 esterase deficiency or any deficiency of the complement system, and plasma cell dyscrasias.
- History of anaphylactic reaction or hypersensitivity to natural or recombinant interferon-beta, human albumin, or proteins derived from CHO cells/formulation.
- History of depression with psychotic features, or requiring ECT or hospitalization, or accompanied by suicidal ideation, gestures, or attempts.
- History of seizure, except for isolated febrile seizure of childhood.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: An Open-Label, Pilot Study of Type I Interferon (AVONEX) Treatment of Ulcerative Colitis
This study will evaluate the safety and effectiveness of the drug interferon-beta1a (AVONEX) in treating ulcerative colitis and examine the drug's effect on the immune system. People with ulcerative colitis have increased amounts of inflammatory chemicals (cytokines) made by immune cells in the lining of the colon. Studies have shown that interferon-beta may block the activity of these cytokines. Interferon-beta1a (AVONEX) is currently FDA-approved to treat multiple sclerosis, a disease involving inflammation of the brain and spinal cord.
Patients 18 years of age and older who have had ulcerative colitis for at least 4 months may be eligible for this study. Candidates will be screened with a review of their medical records, a medical history and physical examination, electrocardiogram (EKG), blood, urine, and stool tests, and a pregnancy test for women of childbearing potential. A colonoscopy will also be done to determine disease activity and extent. This test uses a lighted tube to examine the amount of inflammation in the colon and take tissue samples (biopsies) for testing. Before the test, the patient is given a medicine to allay anxiety and the discomfort of inserting the endoscope into the rectum. This flexible tube allows the doctor to see the intestinal mucosa and project an image of the inner lining of the intestine onto a TV monitor. At various places in the intestine, small pieces of tissue are plucked out by a special device at the tip of the endoscope. The procedure generally lasts 30 minutes to 1 hour.
Read more
Participants will come to the NIH Clinical Center once a week for 4 weeks to receive an injection of interferon-beta, fill out questionnaires, and have a symptoms check, physical examination, and blood tests. Patients whose colitis has not worsened at the end of the 4 weeks and who have not had significant drug side effects will continue to receive weekly injections for an additional 8 weeks. Some patients may receive some of the last eight injections outside of NIH, but all patients will visit the Clinical Center visits every 3 to 4 weeks for a physical exam, symptoms check and blood tests.
After the 12 injections are completed, patients will have another colonoscopy to evaluate the response to treatment and will return to the Clinical Center every 6 weeks for a total of four visits, for a physical examination, symptoms check and blood tests.
Read the detailed description
The purpose of this pilot study is to evaluate the immunologic and clinical response to type I interferon administered to patients with ulcerative colitis. Ulcerative colitis (UC) is a chronic, relapsing inflammation of the colonic mucosa with major symptoms of diarrhea, hematochezia, abdominal pain, and an accompanying increase in colorectal carcinoma risk. Novel approaches to therapy of UC are required because the burden of disease is great (about 500,000 prevalent cases in the United States), standard medical therapy is limited in effectiveness and toxicity, and surgical therapy, albeit curative, results in permanent ostomies or complication-prone alternatives.
The rationale for this study is based on the observation that the mucosal inflammation in UC may be mediated by Th2 cytokines such as IL-4 or cytokines induced along with IL-4. Type I interferons can block IL-4 receptor signaling by up-regulating cytosolic inhibitory proteins (suppressor of cytokines signaling or SOCS proteins). Furthermore, two small studies of type I interferon effects on UC show benefit as opposed to many more studies in Crohn's disease, a classic Th1 inflammatory disease, which have shown no benefit from type I interferons. We hypothesize that type I interferons could be used to inhibit the pro-inflammatory signals of Th2 cytokines in UC.
This study will measure the immunologic and clinical effect of twelve weeks of treatment with a type I interferon administered to patients with active UC. The primary outcomes include documenting changes in immune parameters by measuring peripheral and lamina propria mononuclear cell cytokine release, expression levels of SOCS proteins in mononuclear cells, and changes in clinical parameters using the Short Clinical Colitis Activity Index and endoscopic and histologic scores. Secondary endpoints include the rate and severity of adverse events. Our short-term goal is to correlate changes in immune and biochemical parameters that accompany or predict clinical responses. The long-term goal of this study is to establish type I interferons as an effective alternative or adjunctive therapy with a low risk profile for the treatment of ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- AVONEX
- Keywords
- Lymphocyte, Monocyte, Inflammation, Th2, Colonoscopy, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVONEXDrug
30µg IM every week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Avonex | Experimental | Interferon-beta1a (Avonex) 30 µg IM every week for 12 weeks Receives: Drug: AVONEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)
The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2002 (estimated)
- Study startOct 2002
- Primary completionJun 2008
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Peter J Mannon, MD, Principal investigator, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048347
- Sponsor's protocol ID
- 030019
- Other IDs
- 03-I-0019
- Status last verified
- Aug 2010
- First submitted
- 29 Oct 2002
- Last updated
- 8 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Duchmann R, May E, Heike M, Knolle P, Neurath M, Meyer zum Buschenfelde KH. T cell specificity and cross reactivity towards enterobacteria, bacteroides, bifidobacterium, and antigens from resident intestinal flora in humans. Gut. 1999 Jun;44(6):812-8. doi: 10.1136/gut.44.6.812.
PubMed 10323882
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Study of Type I Interferon (AVONEX) Treatment of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00048347
- Acronym / sponsor ID
- 030019
- Conditions
- Ulcerative Colitis
- Keywords
- Lymphocyte, Monocyte, Inflammation, Th2, Colonoscopy, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2002
- Primary completion
- Jun 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Oct 2002 (estimated)
- Results
- Posted 31 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and effectiveness of the drug interferon-beta1a (AVONEX) in treating ulcerative colitis and examine the drug's effect on the immune system. People with ulcerative colitis have increased amounts of inflammatory chemicals (cytokines) made by immune cells in the lining of the colon. Studies have shown that interferon-beta may block the activity of these cytokines. Interferon-beta1a (AVONEX) is currently FDA-approved to treat multiple sclerosis, a disease involving inflammation of the brain and spinal cord.
Patients 18 years of age and older who have had ulcerative colitis for at least 4 months may be eligible for this study. Candidates will be screened with a review of their medical records, a medical history and physical examination, electrocardiogram (EKG), blood, urine, and stool tests, and a pregnancy test for women of childbearing potential. A colonoscopy will also be done to determine disease activity and extent. This test uses a lighted tube to examine the amount of inflammation in the colon and take tissue samples (biopsies) for testing. Before the test, the patient is given a medicine to allay anxiety and the discomfort of inserting the endoscope into the rectum. This flexible tube allows the doctor to see the intestinal mucosa and project an image of the inner lining of the intestine onto a TV monitor. At various places in the intestine, small pieces of tissue are plucked out by a special device at the tip of the endoscope. The procedure generally lasts 30 minutes to 1 hour.
Participants will come to the NIH Clinical Center once a week for 4 weeks to receive an injection of interferon-beta, fill out questionnaires, and have a symptoms check, physical examination, and blood tests. Patients whose colitis has not worsened at the end of the 4 weeks and who have not had significant drug side effects will continue to receive weekly injections for an additional 8 weeks. Some patients may receive some of the last eight injections outside of NIH, but all patients will visit the Clinical Center visits every 3 to 4 weeks for a physical exam, symptoms check and blood tests.
After the 12 injections are completed, patients will have another colonoscopy to evaluate the response to treatment and will return to the Clinical Center every 6 weeks for a total of four visits, for a physical examination, symptoms check and blood tests.
Detailed description
The purpose of this pilot study is to evaluate the immunologic and clinical response to type I interferon administered to patients with ulcerative colitis. Ulcerative colitis (UC) is a chronic, relapsing inflammation of the colonic mucosa with major symptoms of diarrhea, hematochezia, abdominal pain, and an accompanying increase in colorectal carcinoma risk. Novel approaches to therapy of UC are required because the burden of disease is great (about 500,000 prevalent cases in the United States), standard medical therapy is limited in effectiveness and toxicity, and surgical therapy, albeit curative, results in permanent ostomies or complication-prone alternatives.
The rationale for this study is based on the observation that the mucosal inflammation in UC may be mediated by Th2 cytokines such as IL-4 or cytokines induced along with IL-4. Type I interferons can block IL-4 receptor signaling by up-regulating cytosolic inhibitory proteins (suppressor of cytokines signaling or SOCS proteins). Furthermore, two small studies of type I interferon effects on UC show benefit as opposed to many more studies in Crohn's disease, a classic Th1 inflammatory disease, which have shown no benefit from type I interferons. We hypothesize that type I interferons could be used to inhibit the pro-inflammatory signals of Th2 cytokines in UC.
This study will measure the immunologic and clinical effect of twelve weeks of treatment with a type I interferon administered to patients with active UC. The primary outcomes include documenting changes in immune parameters by measuring peripheral and lamina propria mononuclear cell cytokine release, expression levels of SOCS proteins in mononuclear cells, and changes in clinical parameters using the Short Clinical Colitis Activity Index and endoscopic and histologic scores. Secondary endpoints include the rate and severity of adverse events. Our short-term goal is to correlate changes in immune and biochemical parameters that accompany or predict clinical responses. The long-term goal of this study is to establish type I interferons as an effective alternative or adjunctive therapy with a low risk profile for the treatment of ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avonex | Experimental | Drug: AVONEXInterferon-beta1a (Avonex) 30 µg IM every week for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Corticosteroid-dependence is defined as relapse of ulcerative colitis within 60 days of completing a course of corticosteroid treatment, or during corticosteroid tapering at doses greater than or equal to 10 mg prednisone/day (or equivalent), or within three months following corticosteroid tapering while receiving a steroid dose of greater than or equal to 10 mg prednisone/day (or equivalent).
- Corticosteroids (less than or equal to 25 mg Prednisone/d or Prednisone equivalent) is greater than or equal to 4 weeks;
- 5-ASA/Sulfasalazine is greater than or equal to 4 weeks;
- Azathioprine/6-MP/thioguanine is greater than or equal to 12 weeks. (Note: Patients receiving azathioprine/6-MP/thioguanine must have been on a stable dose of this medication for greater than or equal to 8 weeks before randomization);
- Probiotics (live bacterial dietary supplements) greater than or equal to 4 weeks;
Key exclusion criteria (31 listed)
- Inability to meet any of the above inclusion criteria.
- Use of any of the following medications within the specified time period prior to the first dose of interferon-beta or at any time during the study:
- Non-steroidal anti-inflammatory agents (including COX-2 inhibitors), - 1 week
- Corticosteroids (greater than 25 mg Prednisone/d or Prednisone equivalent), Methotrexate, Cyclosporin, Tacrolimus, Thalidomide, or Mycophenolate mofetil - 4 weeks
- Monoclonal antibodies to TNF alpha or any Other Biologic (cytokine, anti-cytokine, or integrin-based therapy, for instance) - 4 months
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 |
|---|---|---|
| AVONEX30µg IM every week for 12 weeks | Drug | Avonex |
Primary outcome
Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)
Time frame: Baseline, Week 12
The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10323882Duchmann R, May E, Heike M, Knolle P, Neurath M, Meyer zum Buschenfelde KH. T cell specificity and cross reactivity towards enterobacteria, bacteroides, bifidobacterium, and antigens from resident intestinal flora in humans. Gut. 1999 Jun;44(6):812-8. doi: 10.1136/gut.44.6.812.
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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.
Peter J Mannon, MD principal investigator
National Institutes of Health (NIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVONEX in people with Ulcerative Colitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 14 inclusion and 31 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 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 31 Aug 2010). 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?
Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI) (time frame: Baseline, Week 12). 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 NCT00048347, 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 8 Sep 2010.