Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).

Study Purpose

The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation. The aim of this study is to compare the efficacy of steroids alone vs.#46; combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 UC exacerbation as defined by a Lichtiger score of >10 - Age >18 - Has not been on oral systemic corticosteroids more than 14 days prior to hospitalization - If taking a thiopurine, the dose need to be stable for the last 2 months before admission

    Exclusion Criteria:

    - Pregnant women - Allergy / unable to take prednisone / hydrocortisone/ 5-ASA.
- Active infection - either enteric or elsewhere - Severe renal, liver or cardio respiratory comorbidity - Toxic megacolon, or clinical features suggestive of a need for imminent colectomy - Treatment with an anti-TNF within the prior 3 months - Prior treatment with cyclosporine or tacrolimus within the prior 3 months - Alcohol dependency - Unable or unwilling to provide informed consent - Participating in other clinical trial within the 2 months prior to admission

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02665845
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Saint Etienne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ROBLIN Xavier, MD
Principal Investigator Affiliation CHU SAINT ETIENNE
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France, Greece, Israel, Italy, Korea, Republic of, Serbia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. This recommendation is based on pivotal studies carried 50-60 years ago, by Truelove &Witts. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation. In 1962 truelove et al compared topical and systemic corticosteroid therapy with sulphasalazine, and found steroids to be superior to sulfasalazine. Importantly, there are no data investigating whether the addition and/or continuation of 5-ASA agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. This knowledge gap is pronounced in patients admitted to the hospital for intravenous corticosteroid treatment with moderate severe UC flare, in whom it is currently unknown if the addition of 5-ASA (Oral and/or topical) to corticosteroids will confer additional benefit and improve patients outcomes. Thus, in practical terms, the decision whether to stop or continue 5-ASA treatment or whether to add 5-ASA to steroids in the treatment of moderate-severe UC exacerbation is taken on an arbitrary basis. This is important shortcoming and knowledge gap in current medicine, as patients admitted with moderate-severe UC flare who do not respond to corticosteroids and require salvage therapy with infliximab, cyclosporine, or even urgent colectomy. This makes it prudent to explore any avenue for possible improvement of response to corticosteroids in this setting, for instance by addition of 5ASA. The aim of this study is: To compare the efficacy of steroids alone vs.#46; combination of steroids + 5-ASA in the treatment of moderate- severe UC exacerbation.

Arms & Interventions

Arms

Experimental: 5-ASA group

Patients will receive corticosteroids with optimized 5-ASA.

Active Comparator: Control group

Patients will receive corticosteroids alone.

Interventions

Drug: - 5-ASA

5ASA treatment (oral 5ASA will be given to all patients in this arm, in addition to topical 5ASA in patients who tolerate it).

Drug: - Corticosteroids

Corticosteroids will be given to all patients.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chu Saint Etienne, Saint Etienne, France

Status

Recruiting

Address

Chu Saint Etienne

Saint Etienne, , 42100

Site Contact

Xavier ROBLIN, MD

xavier.roblin@chu-st-etienne.fr

Heraklion, Greece

Status

Not yet recruiting

Address

Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

Heraklion, ,

Site Contact

Karmiris Konstantinos, MD

xavier.roblin@chu-st-etienne.fr

Sheba Medical Center, Tel HaShomer, Ramat-Gan, Israel

Status

Not yet recruiting

Address

Sheba Medical Center

Tel HaShomer, Ramat-Gan,

Site Contact

Har-Noy Ofir, MD

xavier.roblin@chu-st-etienne.fr

Università di Roma Sapienza, Rome, Italy

Status

Not yet recruiting

Address

Università di Roma Sapienza

Rome, ,

Site Contact

Cesarini Monica, MD

xavier.roblin@chu-st-etienne.fr

Seoul, Korea, Republic of

Status

Not yet recruiting

Address

Institute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine

Seoul, ,

Site Contact

Cheon Jae-Hee, MD

xavier.roblin@chu-st-etienne.fr

Belgrade, Serbia

Status

Not yet recruiting

Address

Zvezdara University Clinical Center, Gastroenterology Department

Belgrade, ,

Site Contact

Protic Marijana, MD

xavier.roblin@chu-st-etienne.fr

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