Ulcerative ColitisPhase 4NCT01941589
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
A Phase 4 study testing oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone and corticosteroids only in people with Ulcerative Colitis, run by Sheba Medical Center at 10 sites in 7 countries.
Trial summary
The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior 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?
- oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone and corticosteroids only
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 10 sitesin 7 countries
- Study dates
- Sep 2013to Apr 2021
- Phase
- Phase 4
- 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
- UC known and diagnosed by established clinical-endoscopic and histological criteria or newly-diagnosed UC, based on clinical and endoscopic findings, and about to start treatment with corticosteroids.
- current hospitalization with severe Ulcerative Colitis exacerbation as defined by a Lichtiger score of >10
- age >18
- if taking thiopurines, the dose must be stable for 2 months prior to admission
Who cannot join
- pregnant women
- allergy/unable to take study medications
- active infection
- severe renal/liver/cardiorespiratory condition
- toxic megacolon or signs of imminent colectomy
- treatment with an anti-tumor necrosis factor in 3 months prior to admission
Show all 10Show fewer
- prior treatment with cyclosporin or tacrolimus
- alcohol dependancy
- unwilling/ unable to give an informed consent
- participation in clinical trials in the last 2 months prior to admission
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
China2 sites
6th affiliated hospital of Sun yat-sen university
Guangzhou
Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
Greece2 sites
Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou
Heraklion
Department of Gastroenterology, University Hospital & Medical School of Ionnina
Ioannina
Israel2 sites
Gastroenterology department, Soroka medical center
Beersheba
Sheba Medical Center
Tel HaShomer, 52621
France1 site
Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne
Serbia1 site
Zvezdara University Clinical Center, Gastroenterology Department
Belgrade
South Korea1 site
nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine
Seoul
About this study
Official title: Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
Read the detailed description
he role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
- Conditions
- Ulcerative Colitis
- Being tested
- oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone, corticosteroids only
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO MethylprednisoloneDrug
Also called rafassal, pentasa, asacol, hydrocortisone
maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
corticosteroids onlyDrug
Also called hydrocortisone, solu-cortef, methylprednisolone
IV corticosteroids only
| Study group | Role | What they receive |
|---|---|---|
| present 5-ASA arm 1 | Active comparator | oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone Receives: Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone |
| 5-ASA naive arm 1 | Active comparator | oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone Receives: Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone |
| present 5-ASA arm 2 | Active comparator | IV corticosteroids only / PO Methylprednisolone Receives: Drug: corticosteroids only |
| 5-ASA naive arm 2 | Active comparator | IV corticosteroids only / PO Methylprednisolone Receives: Drug: corticosteroids only |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients who respond to the treatment
Measured: day 7
Secondary outcomes (2)
the percentage of patients in need of a rescue medication
Measured: day 5, 7
colectomy rate
Measured: 1 month, 3 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2021
- Study completionApr 2021
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 Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ofir Harnoy MD, Sheba Medical Center
- Investigators
- Ofir Har-Noy, MD, Principal investigator, Sheba Medical Center, Tel-Hashomer, ISRAEL 52621
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941589
- Sponsor's protocol ID
- SHEBA-13-0401-OH-CTIL
- Status last verified
- May 2022
- First submitted
- 30 Aug 2013
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ben-Horin S, Har-Noy O, Katsanos KH, Roblin X, Chen M, Gao X, Schwartz D, Cheon JH, Cesarini M, Bojic D, Protic M, Theodoropoulou A, Abu-Kaf H, Engel T, Tang J, Veyrard P, Lin X, Mao R, Christodoulou D, Karmiris K, Knezevic-Ivanovski T; ComboMesa investigators. Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2868-2875.e1. doi: 10.1016/j.cgh.2022.02.055. Epub 2022 Mar 8.
PubMed 35272029
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT01941589
- Acronym / sponsor ID
- SHEBA-13-0401-OH-CTIL
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2013
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 13 Sep 2013 (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 role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
Detailed description
he role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| present 5-ASA arm 1 | Active comparator | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisoloneoral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone |
| 5-ASA naive arm 1 | Active comparator | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisoloneoral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone |
| present 5-ASA arm 2 | Active comparator | Drug: corticosteroids onlyIV corticosteroids only / PO Methylprednisolone |
| 5-ASA naive arm 2 | Active comparator | Drug: corticosteroids onlyIV corticosteroids only / PO Methylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- UC known and diagnosed by established clinical-endoscopic and histological criteria or newly-diagnosed UC, based on clinical and endoscopic findings, and about to start treatment with corticosteroids.
- current hospitalization with severe Ulcerative Colitis exacerbation as defined by a Lichtiger score of >10
- age >18
- if taking thiopurines, the dose must be stable for 2 months prior to admission
Key exclusion criteria (10 listed)
- pregnant women
- allergy/unable to take study medications
- active infection
- severe renal/liver/cardiorespiratory condition
- toxic megacolon or signs of imminent colectomy
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 |
|---|---|---|
| oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO MethylprednisoloneAlso: rafassal, pentasa, asacol, hydrocortisonemaximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids | Drug | 5-ASA naive arm 1, present 5-ASA arm 1 |
| corticosteroids onlyAlso: hydrocortisone, solu-cortef, methylprednisoloneIV corticosteroids only | Drug | 5-ASA naive arm 2, present 5-ASA arm 2 |
Primary outcome
percentage of patients who respond to the treatment
Time frame: day 7
2 secondary outcomes
the percentage of patients in need of a rescue medication
Time frame: day 5, 7
colectomy rate
Time frame: 1 month, 3 months post randomization
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 9 May 2022.
- Derived from this study: PubMed 35272029Ben-Horin S, Har-Noy O, Katsanos KH, Roblin X, Chen M, Gao X, Schwartz D, Cheon JH, Cesarini M, Bojic D, Protic M, Theodoropoulou A, Abu-Kaf H, Engel T, Tang J, Veyrard P, Lin X, Mao R, Christodoulou D, Karmiris K, Knezevic-Ivanovski T; ComboMesa investigators. Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2868-2875.e1. doi: 10.1016/j.cgh.2022.02.055. Epub 2022 Mar 8.
- Individual participant dataSharing planned: No
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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.
Ofir Har-Noy, MD principal investigator
Sheba Medical Center, Tel-Hashomer, ISRAEL 52621
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone and corticosteroids only in people with Ulcerative Colitis, run by Sheba Medical Center at 10 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 4 inclusion and 10 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, Greece, Israel, France, Italy 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 patients who respond to the treatment (time frame: day 7). 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 NCT01941589, 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 9 May 2022.