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

Spondylarthropathies Clinical Trial

— REDES-TNF  

Official title:

Evaluation of Clinical Value of Standardized Protocol for Dose-reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy: Open-label, Controlled, Randomized, Multicenter Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604629
• Other study ID #: REDES-TNF/2012
• Secondary ID: 2011-005871-18
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2012
• Last updated: November 16, 2015
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Spanish Clinical Pharmacology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylarthropathies

Intervention

Drug:
• Reduced doses of anti-TNF
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-TNF
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

Locations

Country	Name	City	State
Spain	Hospital Clínic Universitari Sant Joan d'Alacant	Alacant
Spain	Hospital Universitario Príncipe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	IMIM-Hospital del Mar	Barcelona
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Juan Canalejo	La Coruña
Spain	Hospital Universitario de Gran Canaria Dr. Negrín	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital General de Llerena-Zafra	Llerena	Badajoz
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario de Móstoles	Móstoles	Madrid
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Monte Naranco	Oviedo	Asturias
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Comarcal de Palamós	Palamós	Girona
Spain	Hospital Son Llàtzer	Palma de Mallorca	Illes Balears
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital de Sant Joan Despí Moisès Broggi	Sant Joan Despí	Barcelona
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Sant Pau i Santa Tecla	Tarragona
Spain	Hospital General de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Clinical Pharmacology Society	Spanish reumatology Society

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year after inclusion	No
Secondary	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	one year	No
Secondary	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))	last study visit (up to 3 years or December 2014)	No
Secondary	Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit	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) in the last study visit	last study visit (up to 3 years or December 2014)	No
Secondary	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	last study visit (up to 3 years or December 2014)	No
Secondary	Time to clinical reactivation	Time to clinical reactivation, defined according to the criteria of active disease by Spanish Society of Reumatology (SER) consensus, BASDAI + VAS and ASDAS, respectively	last study visit (up to 3 years or December 2014)	No
Secondary	Withdrawal because of clinical requirement to modify the antiTNF treatment.	Proportion of patients who are withdrawn from the study because of clinical requirement to modify the antiTNF treatment.	last study visit (up to 3 years or December 2014)	Yes
Secondary	NSAIDs use	NSAIDs use measured according semiquantitative Dougados criteria	last study visit (up to 3 years or December 2014)	No
Secondary	Suspected Serious Adverse Reactions	Proportion of patients who experience a Serious Adverse Event at least possibly related with anti-TNF therapy.	last study visit (up to 3 years or December 2014)	Yes
Secondary	Time to Suspected Serious Adverse Reaction	Time to Serious Adverse Events at least possibly related with anti-TNF therapy	last study visit (up to 3 years or December 2014)	Yes
Secondary	Proportion of patients in remission after two years from inclusion in the study	Proportion of patients in remission, defined as ASDAS-C point less than 1.3, after two years from inclusion in the study	2 years	No