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

University Hospital Center (CHU)

Status: Completed

Conditions: Spondyloarthritis

Treatments: Drug: Adalimumab, Etanercept, Golimumab or infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01610947

8785 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with spondyloarthritis according to ASAS criteria
• Stable low disease activity for at least 6 months
• Already treated by TNF blocking drug (adalimumab, etanercept or infliximab)

Exclusion criteria

• Raised acute phase reactants
• participation in another clinical trial
• Structural progression of peripheral joint damage
• Scheduled surgery within 12 months
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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398 participants in 2 patient groups

Maintain

Active Comparator group

Description:

Continuation of usual treatment with fixed intervals according to standard recommendations

Treatment:

Drug: Adalimumab, Etanercept, Golimumab or infliximab

Drug: Adalimumab, Etanercept, Golimumab or infliximab

Spacing

Active Comparator group

Description:

Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol.

Treatment:

Drug: Adalimumab, Etanercept, Golimumab or infliximab

Drug: Adalimumab, Etanercept, Golimumab or infliximab