ADALISKIAS: Adalimumab for Acute Disc Prolapse

Sponsor
Kuopio University Hospital
Study ID
NCT01510548
Phase
PHASE3
Status
Unknown

Conditions

  • Disc Prolapse
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Aims: To study the efficacy and safety of adalimumab versus placebo in the treatment of acute disc prolapse will be will be compared up to 12 months after the start of study drug treatment. Study type: A one year,randomized, placebo controlled double blind single center trial. Patients and study drug treatment: The study population consist of 99 patients with sciatica caused by herniated disc prolapse. The study has 3 arms: 33 patients randomized to adalimumab 40mg every week, 33 patients randomized to adalimumab 40mg every other week, and 33 patients randomized to placebo. Study drug treatment period will be six weeks. Methods: Clinical evaluation, global assessments and Oswestry Disability Score and visual analog scale (VAS) will be used as the evaluation of clinical results with the disc prolapse patients confirmed by Magnetic Resonance Imaging. Health related quality of life will be assessed by 15-D questionnaire. Safety will be evaluated by medical examinations, adverse events (AE) collection and laboratory measurements throughout the study period.

Key Dates

Start date
Mar 31, 2007
Status verified
Oct 2013
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab 20 mg per week
    Patient will get at double blind situation adalimumab 20 mg every week (six injections) injections
  • Active Comparator: Adalimumab 40 mg per week
    Patient will get at double blind situation adalimumab 40 mg per week injections
  • Placebo Comparator: placebo arm
    Patient will get at double blind situation placebo (= NaCl liquid solution, absolutely same color as the active drug) injections one per week during six weeks - same as the adalimumab arms

Primary Outcome Measure

Pain [ Time Frame: one year ]

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