Ulcerative ColitisPhase 3NCT01494857
Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
A Phase 3 study testing Adalimumab in people with Ulcerative Colitis, run by Clalit Health Services at 3 sites in Israel.
Trial summary
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 3
- 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
- Male or female ≥ 18 years of age.
- Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
- Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection.
- Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points, despite concurrent treatment with at least 1 of the following (oral corticosteroids or immunosuppressants or both as defined below):
- Stable oral corticosteroid dose (prednisone dose of >= 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisone of < 20 mg/day) for at least 40 days prior to Baseline, and/or
- At least a consecutive 90 day course of azathioprine or 6-mercaptopurine (6 MP) prior to Baseline, with a dose of azathioprine >= 1.5 mg/kg/day or 6 MP >= 1 mg/kg/day (rounded to the nearest available tablet formulation), or a dose that is the highest tolerated by the participant (e.g., due to leukopenia, elevated liver enzymes, nausea) during that time. Participant was to be on a stable dose for at least 28 days prior to Baseline.
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- Concurrent therapy was not required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) during the previous 5 years and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.
- Has to be able to self-administer subcutaneous injections or has caregiver who can reliably administer subcutaneous injections.
- Has to be able and willing to give written informed consent and to comply with the requirements of this study protocol.
Who cannot join
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or is planning bowel surgery.
- Received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
- Received cyclosporine, tacrolimus, or mycophenolate mofetil, within 30 days prior to Baseline.
- Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
- Received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of Screening Period.
- Current diagnosis of fulminant colitis and/or toxic megacolon.
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- Subject with disease limited to the rectum (ulcerative proctitis).
- Current diagnosis of indeterminate colitis.
- Current diagnosis and/or history of Crohn's disease.
- Currently receiving total parenteral nutrition (TPN).
- Subject using aminosalicylates for less than 90 days prior to Baseline or not on a stable dose for at least 28 days prior to Baseline or discontinued use within 28 days of Baseline.
- Subject with positive Clostridium difficile (C. difficile) stool assay.
- Subject who has previously used infliximab or any anti-TNF agent within 56 days of Baseline.
- Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded at any time ("primary non-responder") unless subject experienced a treatment limiting reaction.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Not yet recruiting
Sherutey Briuth Clalit / Clalit HMO
Herzlyia
Timna Naftali, MD, 972-9-9620782, Timna.Naftali@clalit.org.il
Timna Naftali, MD
- Recruiting
Lev Talpiot Clinic, Clalit health Services
Jerusalem
Olga Gourin, +972-50-6260450
Dan Keret, M.D.
- Recruiting
Zevulun Clinic, Clalit Health Services
Kiryat Bialik
Lili Merdler, 972-4-8787955
Lili Merdler, M.D.
About this study
Official title: Open-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics.
Read the detailed description
Ulcerative colitis (UC) is one of the two primary forms of idiopathic inflammatory bowel disease (IBD). Recent studies have shown that TNF- α may play a major role in the etiopathogenesis of UC, justifying the use of anti-TNF-α therapies. Adalimumab is an immunoglobulin G1 that specifically binds to TNF-α, and neutralizes its function; it also modulates the biological response, induced and regulated by TNF-α.
Conventional UC therapy quite commonly does not bring satisfactory results; therefore, interest in new treatment methods has been growing recently. Biological therapy is a highly promising prospect, since it enables to discontinue the use of glucocorticosteroids and immunosuppressives or their dose reduction, shortens the hospitalization period, allows to avoid surgical treatment, extends the clinical response, the remission period and improves the patient's quality of life.
Thus, the present study assesses the clinical response of active ulcerative colitis to adalimumab treatment.
- Conditions
- Ulcerative Colitis
- Being tested
- Adalimumab
- Keywords
- Ulcerative colitis, biological treatment, anti-TNF
- 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 Brand name - Humira (Abbott Pharmaceuticals)
Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Adalimumab 40 mg Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with clinical response per Mayo Score, at Week 12
Measured: week 12
Secondary outcomes (1)
Proportion of subjects with remission per Mayo Score at Week 12.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timna Naftali, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494857
- Sponsor's protocol ID
- KHK - AD001
- Other IDs
- A13-675
- Status last verified
- Oct 2012
- First submitted
- 15 Dec 2011
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01494857
- Acronym / sponsor ID
- KHK - AD001
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, biological treatment, anti-TNF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Dec 2011 (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.
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics.
Detailed description
Ulcerative colitis (UC) is one of the two primary forms of idiopathic inflammatory bowel disease (IBD). Recent studies have shown that TNF- α may play a major role in the etiopathogenesis of UC, justifying the use of anti-TNF-α therapies. Adalimumab is an immunoglobulin G1 that specifically binds to TNF-α, and neutralizes its function; it also modulates the biological response, induced and regulated by TNF-α.
Conventional UC therapy quite commonly does not bring satisfactory results; therefore, interest in new treatment methods has been growing recently. Biological therapy is a highly promising prospect, since it enables to discontinue the use of glucocorticosteroids and immunosuppressives or their dose reduction, shortens the hospitalization period, allows to avoid surgical treatment, extends the clinical response, the remission period and improves the patient's quality of life.
Thus, the present study assesses the clinical response of active ulcerative colitis to adalimumab treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: AdalimumabAdalimumab 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 18 years of age.
- Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
- Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection.
- Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points, despite concurrent treatment with at least 1 of the following (oral corticosteroids or immunosuppressants or both as defined below):
- Concurrent therapy was not required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) during the previous 5 years and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.
Key exclusion criteria (14 listed)
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or is planning bowel surgery.
- Received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
- Received cyclosporine, tacrolimus, or mycophenolate mofetil, within 30 days prior to Baseline.
- Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
- Received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of Screening Period.
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: Brand name - Humira (Abbott Pharmaceuticals)Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks. | Drug | Adalimumab |
Primary outcome
Proportion of subjects with clinical response per Mayo Score, at Week 12
Time frame: week 12
1 secondary outcome
Proportion of subjects with remission per Mayo Score at Week 12.
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Ulcerative Colitis, run by Clalit Health Services at 3 sites in Israel.
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 30 Oct 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timna Naftali, MD (972-3-6923660, Timna.Naftali@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with clinical response per Mayo Score, at Week 12 (time frame: week 12). 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 30 Oct 2012.