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Clinical Trials/EUCTR2012-004482-40-ES
EUCTR2012-004482-40-ES
Active, not recruiting
Not 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 sitesMay 16, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies
Sponsor
FRANCISCO J. BLANCO GARCÍA
Status
Active, not recruiting
Last Updated
12 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 16, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FRANCISCO J. BLANCO GARCÍA

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

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