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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

Tracking Information
First Submitted Date  ICMJE May 17, 2012
First Posted Date  ICMJE May 24, 2012
Last Update Posted Date November 17, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2012)
  • 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
  • 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))
  • 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
  • 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
  • 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
  • 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.
  • NSAIDs use [ Time Frame: last study visit (up to 3 years or December 2014) ]
    NSAIDs use measured according semiquantitative Dougados criteria
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Protocol for Dose Reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spondylarthropathies
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Reduced doses of anti-TNF
  • 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
    Intervention: Drug: Stable doses of anti-TNF
Publications * Gratacós J, Pontes C, Juanola X, Sanz J, Torres F, Avendaño C, Vallano A, Calvo G, de Miguel E, Sanmartí R; REDES-TNF investigators. Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis. Arthritis Res Ther. 2019 Jan 8;21(1):11. doi: 10.1186/s13075-018-1772-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2015)
120
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2012)
190
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01604629
Other Study ID Numbers  ICMJE REDES-TNF/2012
2011-005871-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dra. Caridad Pontes, Spanish Clinical Pharmacology Society
Study Sponsor  ICMJE Spanish Clinical Pharmacology Society
Collaborators  ICMJE Spanish reumatology Society
Investigators  ICMJE
Principal Investigator: Gratacós Jordi, MD, PhD Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB
PRS Account Spanish Clinical Pharmacology Society
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP