Open-Label Adalimumab for Ulcerative Colitis Patients

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT00421642
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    The loading dose will be 160 mg. A dose of 80 mg will be given at Week 2 and 40 mg every other week starting at Week 4 until completion at Week 24. If it is found that they are not responding to 40 mg of adalimumab at Week 8 or later, the dose may be increased to 40 mg weekly.

Study Details

This is an open-label study of 20 patients designed to demonstrate the safety, tolerability and preliminary evidence of benefit of adalimumab in the treatment of subjects with Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who have lost response or developed intolerance to previous infliximab therapy.

Key Dates

Start date
Oct 31, 2006
Status verified
Jul 2012
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

The Primary pilot efficacy variable will be the induction of clinical response, which is defined as a decrease in Mayo score less than 30% from baseline or less than 3 points PLUS decrease in rectal bleeding sub-score less than or equal to 1 at week 8 [ Time Frame: 24 Weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259-
University of ChicagoChicagoIllinois60637-
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Mayo Clinic· Scottsdale, AZUniversity of Chicago· Chicago, ILMayo Clinic· Rochester, MN

Related Studies