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

NCT01604629 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-11-17

No results posted yet for this study

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.

Conditions

  • Spondylarthropathies

Interventions

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

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

Sponsors & Collaborators

  • Spanish reumatology Society

    collaborator UNKNOWN

  • Spanish Clinical Pharmacology Society

    lead OTHER

Principal Investigators

  • Gratacós Jordi, MD, PhD · Hospital de Sabadell - Corporació Sanitària i Universitaria Parc Taulí UAB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-04-30
Completion
2015-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604629 on ClinicalTrials.gov