Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis

Sheba Medical Center

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; Drug: corticosteroids only

Study type: Interventional

Funder types: Other

Identifiers

NCT01941589

SHEBA-13-0401-OH-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

149 participants in 4 patient groups

present 5-ASA arm 1

Active Comparator group

Description:

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

Treatment:

Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

5-ASA naive arm 1

Active Comparator group

Description:

oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

Treatment:

Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone

present 5-ASA arm 2

Active Comparator group

Description:

IV corticosteroids only / PO Methylprednisolone

Treatment:

Drug: corticosteroids only

5-ASA naive arm 2

Active Comparator group

Description:

IV corticosteroids only / PO Methylprednisolone

Treatment:

Drug: corticosteroids only