Study of Adalimumab in Patients With Axial Spondyloarthritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT00939003
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    40 mg every other week up to Week 12
  • Placebo — BIOLOGICAL
    Placebo every other week up to Week 12
  • Open-label Adalimumab — BIOLOGICAL
    40 mg every other week, Week 12 through Week 156

Study Details

This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

Key Dates

Start date
Jul 31, 2009
Status verified
Sep 2014
Primary completion
Feb 28, 2011
Completion
Aug 31, 2013

Study Design

Enrollment
192 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab
  • Placebo Comparator: Placebo
  • Experimental: Open-label Adalimumab

Primary Outcome Measure

Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response [ Time Frame: Baseline and Week 12 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 21250BirminghamAlabama35205-
Site Reference ID/Investigator# 21249Colorado SpringsColorado80910-
Site Reference ID/Investigator# 21245DenverColorado80230-
Site Reference ID/Investigator# 21246WheatonMaryland20902-
Site Reference ID/Investigator# 26582DuncansvillePennsylvania16635-
Site Reference ID/Investigator# 21241WyomissingPennsylvania19610-
Site Reference ID/Investigator# 21243DallasTexas75231-
Site Reference ID/Investigator# 21248HoustonTexas77030-
Site Reference ID/Investigator# 21247SeattleWashington98122-

Find similar trials in Birmingham, AL

By research site
Site Reference ID/Investigator# 21250· Birmingham, ALSite Reference ID/Investigator# 21249· Colorado Springs, COSite Reference ID/Investigator# 21245· Denver, COSite Reference ID/Investigator# 21246· Wheaton, MDSite Reference ID/Investigator# 26582· Duncansville, PASite Reference ID/Investigator# 21241· Wyomissing, PA

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