Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

Part of paid clinical trials in Abbott Park, Illinois.

Sponsor
Abbott
Study ID
NCT00427921
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    160 mg loading dose, 80 mg at week 2, 40 mg every other week

Study Details

To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.

Key Dates

Start date
Jan 31, 2007
Status verified
Nov 2009
Primary completion
Jan 31, 2008
Completion
Jan 31, 2008

Study Design

Enrollment
304 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Open Label

Primary Outcome Measure

Mean Extent of Exposure - Duration in Days [ Time Frame: Up to 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Global Medical Information - AbbottAbbott ParkIllinois60064-

Find similar trials in Abbott Park, IL

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Global Medical Information - Abbott· Abbott Park, IL

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