Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity

Sponsor
University Hospital, Montpellier
Study ID
NCT01610947
Status
Completed

Conditions

  • Spondyloarthritis

Eligibility Criteria

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

Interventions

Study Details

Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.

Key Dates

Start date
May 14, 2012
Status verified
Oct 2021
Primary completion
Oct 18, 2018
Completion
Oct 18, 2018

Study Design

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

Arms

  • Active Comparator: Maintain
    Continuation of usual treatment with fixed intervals according to standard recommendations
  • Active Comparator: Spacing
    Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.

Primary Outcome Measure

Proportion of patients remaining in low disease activity [ Time Frame: 12 months ]

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