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

NCT ID: NCT01610947

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-14

Study Completion Date

2018-10-18

Brief Summary

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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.

Detailed Description

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Conditions

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Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maintain

Continuation of usual treatment with fixed intervals according to standard recommendations

Group Type ACTIVE_COMPARATOR

Adalimumab, Etanercept, Golimumab or infliximab

Intervention Type DRUG

Continuation of usual treatment with fixed intervals according to standard recommendations

Spacing

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

Group Type ACTIVE_COMPARATOR

Adalimumab, Etanercept, Golimumab or infliximab

Intervention Type DRUG

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

Interventions

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Adalimumab, Etanercept, Golimumab or infliximab

Continuation of usual treatment with fixed intervals according to standard recommendations

Intervention Type DRUG

Adalimumab, Etanercept, Golimumab or infliximab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lapeyronie Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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8785

Identifier Type: -

Identifier Source: org_study_id