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

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ClinicalTrials.gov Identifier: NCT01604629
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Spanish reumatology Society
Information provided by (Responsible Party):
Dra. Caridad Pontes, Spanish Clinical Pharmacology Society

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Spondylarthropathies Drug: Reduced doses of anti-TNF Drug: Stable doses of anti-TNF Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : July 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : September 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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))

  3. 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

  4. 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

  5. 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

  6. 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.

  7. NSAIDs use [ Time Frame: last study visit (up to 3 years or December 2014) ]
    NSAIDs use measured according semiquantitative Dougados criteria

  8. 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.

  9. 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

  10. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604629


Locations
Spain
Hospital Monte Naranco
Oviedo, Asturias, Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain
Hospital General de Llerena-Zafra
Llerena, Badajoz, Spain
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Hospital Comarcal de Palamós
Palamós, Girona, Spain
Hospital Son Llàtzer
Palma de Mallorca, Illes Balears, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Clínic Universitari Sant Joan d'Alacant
Alacant, Spain
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Vall d'Hebron
Barcelona, Spain
IMIM-Hospital del Mar
Barcelona, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Juan Canalejo
La Coruña, 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 Virgen de la Arrixaca
Murcia, Spain
Hospital Clínico de Salamanca
Salamanca, Spain
Hospital Universitario Virgen Macarena
Sevilla, Spain
Hospital Sant Pau i Santa Tecla
Tarragona, Spain
Hospital General de Valencia
Valencia, Spain
Sponsors and Collaborators
Spanish Clinical Pharmacology Society
Spanish reumatology Society
Investigators
Principal Investigator: Gratacós Jordi, MD, PhD Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dra. Caridad Pontes, Study coordinator, Spanish Clinical Pharmacology Society
ClinicalTrials.gov Identifier: NCT01604629     History of Changes
Other Study ID Numbers: REDES-TNF/2012
2011-005871-18 ( EudraCT Number )
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Dra. Caridad Pontes, Spanish Clinical Pharmacology Society:
Spondylarthropathies
Persistent clinical remission with anti-TNF therapy
Standardized protocol for dose reduction anti-TNF therapy

Additional relevant MeSH terms:
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Adalimumab
Etanercept
Infliximab
Antibodies, Monoclonal
 Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Dermatologic Agents