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

NCT01610947 | Completed

• 1 other identifier: 8785
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spondyloarthritis

Keywords

Spondyloarthritis; Anti-TNF; Adalimumab; Etanercept; Infliximab

Outcome Measures

Primary Outcomes (1)

• Proportion of patients remaining in low disease activity

  12 months

Secondary Outcomes (1)

• Medico-economic comparison of arms

  12 months

Study Arms (2)

Maintain

ACTIVE COMPARATOR

Continuation of usual treatment with fixed intervals according to standard recommendations

Drug: Adalimumab, Etanercept, Golimumab or infliximab

Spacing

ACTIVE COMPARATOR

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

Drug: Adalimumab, Etanercept, Golimumab or infliximab

Interventions

Adalimumab, Etanercept, Golimumab or infliximab DRUG

Continuation of usual treatment with fixed intervals according to standard recommendations

Maintain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Lapeyronie Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Spondylarthritis

Interventions

Adalimumab; Etanercept; golimumab; Infliximab

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 4, 2012
• Study Start: May 14, 2012
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

FR (1)