A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis

Sponsor
Dr. FRANCISCO J. BLANCO-GARCIA
Study ID
NCT00963313
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab (HUMIRA®) — DRUG
    Prefilled syringes containing 40 mg Adalimumab in 0.8 ml injection solution. Study drug will be subcutaneously self-administered every 2 weeks during 24 weeks.

Study Details

Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement.

Key Dates

Start date
Mar 31, 2010
Status verified
Sep 2014
Primary completion
Jun 30, 2012
Completion
Jun 30, 2014

Study Design

Enrollment
29 participants (actual)

Arms

  • Arm: Adalimumab, injection
    Adalimumab, one injection every fourteen days during 24 weeks.

Primary Outcome Measure

BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index). [ Time Frame: 12 WEEKS ]

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