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Completed

NCT Number: NCT01604629

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

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.

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Key information

Conditions

Spondylarthropathies Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic Universitari Sant Joan d'Alacant, Alicante, Alacant, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reduced doses of anti-TNF

Drug

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

Stable doses of anti-TNF

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Spanish Clinical Pharmacology Society

Other

Collaborators

  • Spanish reumatology Society

Registry information

Official study 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.

Acronym: REDES-TNF

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 24, 2012
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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