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

Primary Purpose

Spondylarthropathies

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Reduced doses of anti-TNF

Stable doses of anti-TNF

About this trial

This is an interventional treatment trial for Spondylarthropathies focused on measuring Spondylarthropathies, Persistent clinical remission with anti-TNF therapy, Standardized protocol for dose reduction anti-TNF therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reduced doses of anti-TNF

Stable doses of anti-TNF

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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))

Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit

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

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

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.

NSAIDs use

NSAIDs use measured according semiquantitative Dougados criteria

Suspected Serious Adverse Reactions

Proportion of patients who experience a Serious Adverse Event at least possibly related with anti-TNF therapy.

Time to Suspected Serious Adverse Reaction

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

Proportion of patients in remission, defined as ASDAS-C point less than 1.3, after two years from inclusion in the study

Full Information

NCT ID

NCT01604629

First Posted

May 17, 2012

Last Updated

November 16, 2015

Sponsor

Spanish Clinical Pharmacology Society

Collaborators

Spanish reumatology Society

1. Study Identification

Unique Protocol Identification Number

NCT01604629

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spanish Clinical Pharmacology Society

Collaborators

Spanish reumatology Society

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondylarthropathies

Keywords

Spondylarthropathies, Persistent clinical remission with anti-TNF therapy, Standardized protocol for dose reduction anti-TNF therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reduced doses of anti-TNF

Arm Type

Experimental

Arm Description

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

Arm Title

Stable doses of anti-TNF

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Reduced doses of anti-TNF

Other Intervention Name(s)

Adalimumab: 40 mg / 3 weeks, Etanercept: 50 mg / 10 days, Golimumab: 50 mg / 6 weeks, Infliximab: 3 mg/kg / 8 weeks

Intervention Description

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 Type

Drug

Intervention Name(s)

Stable doses of anti-TNF

Other Intervention Name(s)

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

Intervention Description

Primary Outcome Measure Information:

Title

Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year

Description

Time Frame

one year after inclusion

Secondary Outcome Measure Information:

Title

Proportion of patients in remission one year after inclusion in the study

Description

Proportion of patients in remission, defined as ASDAS-C score lower than than 1.3, after one year from inclusion in the study

Time Frame

one year

Title

Proportion of patients who experience a clinical reactivation

Description

Time Frame