Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD

NCT ID: NCT03059849

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-09-01

Brief Summary

To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.

Detailed Description

Patients using adalimumab for Crohn's disease or ulcerative colitis who are in clinical remission will be followed with fecal calprotectin monitoring every 3 months. Patients with a sustained rise in calprotectin who maintain clinical remission will be offered an opportunity to have an increase in adalimumab for three months. Patients who use the three months of increased adalimumab dosing will be compared to patients who do not use increased dosing to determine if relapse rates differ between these two groups.

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temporary increase in adalimumab

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: DRUG

Dose of adalimumab will be increased by 40mg every 2 weeks.

Continued monitoring as per standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adalimumab

Dose of adalimumab will be increased by 40mg every 2 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adults ages 18 and older with Crohn's disease and ulcerative colitis

2. Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)

3. Patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly).

Exclusion Criteria

1. Pregnant women or plans for pregnancy within 3 months of study inclusion

2. Abdominal abscess

3. Inability or unwillingness to provide informed consent

4. Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2831

Identifier Type: -

Identifier Source: org_study_id