EUCTR2012-004482-40-ESActive, not recruitingNot Applicable
Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.
FRANCISCO J. BLANCO GARCÍA0 sitesStarted: May 16, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •? Patients over 18 years.
- •? Patients with rheumatoid arthritis (RA) according to the classification of the 1987 ACR criteria.
- •? Patients treated with biologic therapy (infliximab, adalimumab, etanercept, golimumab, certolizumab, abatacept, rituximab, tocilizumab) showing an established clinical remission.
- •? Patients who are in remission (defined by a DAS28 <2.4 or SDAI <3.3) during the last 6 months prior the baseline visit.
- •? Patients who give their informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
Exclusion Criteria
- •? Patients with RA and clinic predominantly systemic manifestations to which biological therapy on the occasion of such systemic manifestations have been instructed.
- •? Patients with AR and any associated pathology known that interfere with or modify the clinical evaluation of the patient (fibromyalgia or association to another chronic inflammatory disease).
- •? Patients in chronic treatment with biologic therapy that are already in some patterns of reduction which will be studied in the experimental group, or guidelines of dose lower or more spaced than the of the experimental group, prior to inclusion in the study.
Investigators
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