Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study

Sponsor
Chung Shan Medical University
Study ID
NCT02489760
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
  • Etanercept — BIOLOGICAL
    The control arm will continue etanercept 25 mg subcutaneously twice a week

Study Details

To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.

Key Dates

Start date
Jul 31, 2008
Status verified
Jan 2016
Primary completion
Dec 31, 2015
Completion
Oct 31, 2016

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab switch to Etanercept
    At week 8, the treatment arm will be switched to etanercept 25 mg subcutaneously biweekly for another 8 weeks.
  • Experimental: Etanercept switch to Adalimumab
    At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.

Primary Outcome Measure

Bath AS disease activity index (BASDAI) [ Time Frame: weeks 8 ]

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