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

November 16, 2015 updated by: Dra. Caridad Pontes, Spanish Clinical Pharmacology Society

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alacant, Spain
        • Hospital Clínic Universitari Sant Joan d'Alacant
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital Vall d'hebrón
      • Barcelona, Spain
        • IMIM-Hospital del Mar
      • Córdoba, Spain
        • Hospital Reina Sofía
      • Guadalajara, Spain
        • Hospital Universitario de Guadalajara
      • La Coruña, Spain
        • Hospital Juan Canalejo
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario de La Princesa
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Murcia, Spain
        • Hospital Universitario Virgen de la Arrixaca
      • Salamanca, Spain
        • Hospital Clínico de Salamanca
      • Sevilla, Spain
        • Hospital Universitario Virgen Macarena
      • Tarragona, Spain
        • Hospital Sant Pau i Santa Tecla
      • Valencia, Spain
        • Hospital General de Valencia
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Universitario Central de Asturias
      • Oviedo, Asturias, Spain
        • Hospital Monte Naranco
    • Badajoz
      • Llerena, Badajoz, Spain
        • Hospital General de Llerena-Zafra
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Sant Joan Despí, Barcelona, Spain
        • Hospital de Sant Joan Despi Moises Broggi
    • Girona
      • Palamós, Girona, Spain
        • Hospital Comarcal de Palamós
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain
        • Hospital Son Llatzer
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain
        • Hospital Universitario de Gran Canaria Dr. Negrín
    • Madrid
      • Alcalá de Henares, Madrid, Spain
        • Hospital Universitario Príncipe de Asturias
      • Alcorcón, Madrid, Spain
        • Hospital Universitario Fundacion Alcorcon
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta De Hierro
      • Móstoles, Madrid, Spain
        • Hospital Universitario de Móstoles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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
Other Names:
  • Adalimumab: 40 mg / 3 weeks
  • Etanercept: 50 mg / 10 days
  • Golimumab: 50 mg / 6 weeks
  • Infliximab: 3 mg/kg / 8 weeks
Active Comparator: 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
Drug: 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
Other Names:
  • Adalimumab: 40 mg / 2 weeks
  • Etanercept: 25 mg / 3 days ó 50 mg /7 days
  • Golimumab: 50 mg / 4 weeks
  • Infliximab: 5 mg/kg / 6-8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year
Time Frame: one year after inclusion
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients in remission one year after inclusion in the study
Time Frame: one year
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
Proportion of patients who experience a clinical reactivation
Time Frame: last study visit (up to 3 years or December 2014)
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)
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 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)
Proportion of patients who are kept in the ideal therapeutic objective in the last follow visit
Time Frame: last study visit (up to 3 years or December 2014)
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)
Time to clinical reactivation
Time Frame: last study visit (up to 3 years or December 2014)
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)
Withdrawal because of clinical requirement to modify the antiTNF treatment.
Time Frame: last study visit (up to 3 years or December 2014)
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)
NSAIDs use
Time Frame: last study visit (up to 3 years or December 2014)
NSAIDs use measured according semiquantitative Dougados criteria
last study visit (up to 3 years or December 2014)
Suspected Serious Adverse Reactions
Time Frame: last study visit (up to 3 years or December 2014)
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)
Time to Suspected Serious Adverse Reaction
Time Frame: last study visit (up to 3 years or December 2014)
Time to Serious Adverse Events at least possibly related with anti-TNF therapy
last study visit (up to 3 years or December 2014)
Proportion of patients in remission after two years from inclusion in the study
Time Frame: 2 years
Proportion of patients in remission, defined as ASDAS-C point less than 1.3, after two years from inclusion in the study
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spanish Clinical Pharmacology Society

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spanish reumatology Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gratacós Jordi, MD, PhD, Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REDES-TNF/2012
  • 2011-005871-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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