Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-04-30

Brief Summary

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The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1.0

As per routinary clinical practice

As per clinical practice

Intervention Type OTHER

As per clinical practice

Interventions

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As per clinical practice

Intervention Type OTHER

Other Intervention Names

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Observational study

Eligibility Criteria

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Inclusion Criteria

1. Eighteen years of age or older
2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:

1. Morning stiffness in and around the joints lasting at least 1 hour;
2. Arthritis of 3 or more joint areas;
3. Arthritis of hand joints;
4. Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
5. Rheumatoid nodules;
6. Serum Rheumatoid Factor (RF)
7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
3. Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
4. Patients naive to anti-TNF drugs
5. Outpatients