Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis

Sponsor
Rigshospitalet, Denmark
Study ID
NCT01029847
Phase
PHASE4
Status
Completed

Conditions

  • Spondyloarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Sc. inj. adalimumab 40 mg every other week for 42 to 48 weeks. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.
  • Placebo — DRUG
    sc. inj. placebo every other week, week 0, 2, and 4. Sc. inj. adalimumab 40 mg every other week from week 6. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.

Study Details

Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare ultrasound examination with wholebody MRI etc.

Key Dates

Start date
Dec 31, 2009
Status verified
Jan 2019
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

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

Arms

  • Placebo Comparator: Placebo
  • Active Comparator: Adalimumab
    TNF-alpha inhibitor

Primary Outcome Measure

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 20 mm or 50% [ Time Frame: 24 weeks ]

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