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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Clinical Pharmacology Society
• Collaborator: Spanish reumatology Society
• Treatments: Adalimumab; Antibodies, Monoclonal; Etanercept; Golimumab; Infliximab

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