Ulcerative ColitisPhase 1NCT00421642
Open-Label Adalimumab for Ulcerative Colitis Patients
A Phase 1 study testing Adalimumab in people with Ulcerative Colitis, run by Mayo Clinic at 3 sites in United States.
Trial summary
This is an open-label study of 20 patients designed to demonstrate the safety, tolerability and preliminary evidence of benefit of adalimumab in the treatment of subjects with Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who have lost response or developed intolerance to… 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?
- Adalimumab
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2006to Apr 2008
- Phase
- Phase 1
- 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
- Males and females 18 years of age and older
- Female subjects must utilize a highly effective method of birth control throughout the study and for 70 days after study completion, or female subjects must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- A diagnosis of UC for greater than 3 months.
- UC diagnosis confirmed by endoscopy with exclusion of infectious cause.
- Active ulcerative colitis with a Mayo Clinic Score (see Appendix C) of 6 to 12 points with moderately-to-severely active disease on sigmoidoscopy (endoscopic subscore of at least 2) despite concurrent treatment with corticosteroids, and/or azathioprine or 6 mercaptopurine and/or 5-aminosalicylate-containing medications. Patients who previously have not responded to or could not tolerate corticosteroids (within the past 18 months), or azathioprine or 6 mercaptopurine (both within the past 5 years), or 5 aminosalicylate-containing medications (within the past 18 months) will not required to be taking concurrent therapy at enrollment.
- Either anti-TNF agent naïve or those with previous clinical response to infliximab therapy for UC with subsequent loss of response AND/OR are unable to tolerate further infliximab therapy for UC due to acute or delayed reactions, as defined by the investigator.
- Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
- Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.
Who cannot join
- History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin.
- Subjects with a history of Listeria, Hepatitis B infection, central nervous system (CNS) demyelinating disease, or human immunodeficiency virus (HIV) or a history of previously untreated TB. See Appendix B.
- Subjects with Crohn?s Disease
- Subjects with symptomatic obstructive strictures
- Subjects who have had subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for ulcerative colitis or are planning subtotal colectomy or colectomy within 8 weeks of starting the study medication.
- Subjects who are currently receiving total parenteral nutrition (TPN).
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- Any investigational chemical agent in the past 30 days or 5 half-lives prior to screening (whichever is longer). Patients who have previously been treated with infliximab and responded, and then become intolerant to infliximab or lost response, can be treated >/= 4 weeks from their last infliximab dose.
- Antibiotic treatment for any systemic infection within 3 weeks prior to screening.
- Female subjects who are pregnant or breast-feeding.
- History of clinically significant drug or alcohol abuse in the prior year.
- Poorly controlled medical condition, including but not limited to diabetes with documented history of recurrent infections or cerebrovascular accidents (within 3 months).
- Subjects who have been on cyclosporine or tacrolimus within 4 weeks of screening.
- Subjects who have been on methotrexate within 4 weeks of screening.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60637
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Ulcerative Colitis Patients
This is an open-label study of 20 patients designed to demonstrate the safety, tolerability and preliminary evidence of benefit of adalimumab in the treatment of subjects with Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who have lost response or developed intolerance to previous infliximab therapy.
- Conditions
- Ulcerative Colitis
- Being tested
- Adalimumab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
The loading dose will be 160 mg. A dose of 80 mg will be given at Week 2 and 40 mg every other week starting at Week 4 until completion at Week 24. If it is found that they are not responding to 40 mg of adalimumab at Week 8 or later, the dose may be increased to 40 mg weekly.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary pilot efficacy variable will be the induction of clinical response, which is defined as a decrease in Mayo score less than 30% from baseline or less than 3 points PLUS decrease in rectal bleeding sub-score less than or equal to 1 at week 8
Measured: 24 Weeks
Secondary outcomes (5)
Clinical remission at each visit
Measured: 24 Weeks
Clinical response at each visit
Measured: 24 Weeks
Improvement in the mucosal inflammation at week 8
Measured: 24 Weeks
Mayo Score
Measured: 24 Weeks
Ability to taper and discontinue steroids according to the tapering schedule after week 8
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- William J. Sandborn, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421642
- Sponsor's protocol ID
- 06-002167
- Status last verified
- Jul 2012
- First submitted
- 11 Jan 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Afif W, Leighton JA, Hanauer SB, Loftus EV Jr, Faubion WA, Pardi DS, Tremaine WJ, Kane SV, Bruining DH, Cohen RD, Rubin DT, Hanson KA, Sandborn WJ. Open-label study of adalimumab in patients with ulcerative colitis including those with prior loss of response or intolerance to infliximab. Inflamm Bowel Dis. 2009 Sep;15(9):1302-7. doi: 10.1002/ibd.20924.
PubMed 19408340
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT00421642
- Acronym / sponsor ID
- 06-002167
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study of 20 patients designed to demonstrate the safety, tolerability and preliminary evidence of benefit of adalimumab in the treatment of subjects with Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who have lost response or developed intolerance to previous infliximab therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females 18 years of age and older
- Female subjects must utilize a highly effective method of birth control throughout the study and for 70 days after study completion, or female subjects must not be of childbearing potential, defined as postmenopausal at least two years, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- A diagnosis of UC for greater than 3 months.
- UC diagnosis confirmed by endoscopy with exclusion of infectious cause.
- Active ulcerative colitis with a Mayo Clinic Score (see Appendix C) of 6 to 12 points with moderately-to-severely active disease on sigmoidoscopy (endoscopic subscore of at least 2) despite concurrent treatment with corticosteroids, and/or azathioprine or 6 mercaptopurine and/or 5-aminosalicylate-containing medications. Patients who previously have not responded to or could not tolerate corticosteroids (within the past 18 months), or azathioprine or 6 mercaptopurine (both within the past 5 years), or 5 aminosalicylate-containing medications (within the past 18 months) will not required to be taking concurrent therapy at enrollment.
Key exclusion criteria (13 listed)
- History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin.
- Subjects with a history of Listeria, Hepatitis B infection, central nervous system (CNS) demyelinating disease, or human immunodeficiency virus (HIV) or a history of previously untreated TB. See Appendix B.
- Subjects with Crohn?s Disease
- Subjects with symptomatic obstructive strictures
- Subjects who have had subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for ulcerative colitis or are planning subtotal colectomy or colectomy within 8 weeks of starting the study medication.
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 |
|---|---|---|
| AdalimumabAlso: HumiraThe loading dose will be 160 mg. A dose of 80 mg will be given at Week 2 and 40 mg every other week starting at Week 4 until completion at Week 24. If it is found that they are not responding to 40 mg of adalimumab at Week 8 or later, the dose may be increased to 40 mg weekly. | Drug | – |
Primary outcome
The Primary pilot efficacy variable will be the induction of clinical response, which is defined as a decrease in Mayo score less than 30% from baseline or less than 3 points PLUS decrease in rectal bleeding sub-score less than or equal to 1 at week 8
Time frame: 24 Weeks
5 secondary outcomes
Clinical remission at each visit
Time frame: 24 Weeks
Clinical response at each visit
Time frame: 24 Weeks
Improvement in the mucosal inflammation at week 8
Time frame: 24 Weeks
Mayo Score
Time frame: 24 Weeks
Ability to taper and discontinue steroids according to the tapering schedule after week 8
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Results publication: PubMed 19408340Afif W, Leighton JA, Hanauer SB, Loftus EV Jr, Faubion WA, Pardi DS, Tremaine WJ, Kane SV, Bruining DH, Cohen RD, Rubin DT, Hanson KA, Sandborn WJ. Open-label study of adalimumab in patients with ulcerative colitis including those with prior loss of response or intolerance to infliximab. Inflamm Bowel Dis. 2009 Sep;15(9):1302-7. doi: 10.1002/ibd.20924.
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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.
William J. Sandborn, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adalimumab in people with Ulcerative Colitis, run by Mayo Clinic at 3 sites 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 8 inclusion and 13 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 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The Primary pilot efficacy variable will be the induction of clinical response, which is defined as a decrease in Mayo score less than 30% from baseline or less than 3 points PLUS decrease in rectal bleeding sub-score less than or equal to 1 at week 8 (time frame: 24 Weeks). 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 NCT00421642, 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 1 Aug 2012.