Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF

Spanish Clinical Pharmacology Society120 enrolled

Overview

The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.

It has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Spondylarthropathies

Interventions

Reduced doses of anti-TNFDRUG

Standardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab

Stable doses of anti-TNFDRUG

Stable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 18 years * Patients with Spondylarthropathies according ASAS group criteria. * Patients under treatment with anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab) who present established clinical remission * Patients to give their informed consent to participate in the study Exclusion Criteria: * Patients with secondary Spondylarthropathies * Patients with Spondylarthropathies and predominantly clinical of peripheral arthritis which receive anti-TNF therapy by peripheral symp tons. * Patients with Spondylarthropathies and other associated diseases that hinders or modify the clinical evaluation of the patient (fibromyalgia, chronic inflammatory disorders…) * Patients with bowel inflammatory disease * Patients under chronic therapy with anti-TNF therapy who received the patterns of reduction that will be explored in the experimental group, or low doses or most spaced that those in the experimental group before study inclusion

Locations (31)

Outcomes

Primary Outcomes

Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year

Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Society of Reumatology (SER) consensus (BASDAI \< 4, global clinical impression by physician \<4 and by patient \< 4 and axial nocturnal pain \<4) after one year

Time frame: one year after inclusion

Secondary Outcomes

Proportion of patients in remission one year after inclusion in the study

Proportion of patients in remission, defined as ASDAS-C score lower than than 1.3, after one year from inclusion in the study

Time frame: one year

Proportion of patients who experience a clinical reactivation

Proportion of patients who experience a clinical reactivation, defined according criteria of active disease by Spanish Society of Reumatology (SER) consensus (BASDAI \> 4, global clinical impression by physician \>4 and at least one of three following criteria: patient impression \>= 4, axial nocturnal pain (VAS) \>= 4, and increased of acute phase reactants (reactive C protein (PCR) and/or erytrocyte sedimentation rate (ESR))

Time frame: last study visit (up to 3 years or December 2014)

Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit

Time frame: last study visit (up to 3 years or December 2014)

Proportion of patients who are kept in the ideal therapeutic objective in the last follow visit

Proportion of patients who are kept in the ideal therapeutic objective according to the Spanish Society of Reumatology (SER) consensus (BASDAI \< 2, global clinical impression by physician \<2 and by patient \< 2 ) in the last study visit

Data from ClinicalTrials.gov

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