Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies

• 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; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-004482-40-ES
• Lead Sponsor: FRANCISCO J. BLANCO GARCÍA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified