Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial

Phase 1

• Conditions: uminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy; MedDRA version: 8.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2006-006632-22-BE
• Lead Sponsor: niversity of Leuven, Division of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-19
• Study Completion: 2010-05-15
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Men and women of 18 years and older willing and able to give written informed consent.
2.Patients in clinical remission and/or complete response (as judged by the investigator) (CDAI<200) on infliximab treatment (5mg/kg q8 weeks) for at least 6 months.
3.Patients with a documented clinical response to infliximab of 8 weeks duration. Patients with a draining perianal fistula at the time of diagnosis, who receive infliximab for luminal disease are eligible.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients receiving infliximab doses exceeding 5 mg/kg
2.Incomplete response to infliximab (CDAI>200)
3.Pregnant or lactating women. Men and women of childbearing potential should use a effective double barrier method for contraception.
4.Patients with intercurrent medical conditions or laboratory abnormalities that preclude further administration of anti-TNF agents such as demyelinating diseases or severe heart failure.
5.Patients with an imminent need for surgery such as those with a symptomatic fibrotic stricture.
6.Patients with a draining abdominal enterocutaneous fistula.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified