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

Sponsor
McMaster University
Study ID
NCT03059849
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Dose of adalimumab will be increased by 40mg every 2 weeks.

Study Details

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.

Key Dates

Start date
Feb 1, 2018
Status verified
Feb 2017
Primary completion
Feb 1, 2019
Completion
Sep 1, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Temporary increase in adalimumab
  • No Intervention: Continued monitoring as per standard of care

Primary Outcome Measure

Number of patients with clinical relapse [ Time Frame: One year ]

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