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

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: As per clinical practice

Study type: Observational

Funder types: Industry

Identifiers

NCT00794118

B1801119

0881A1-102321

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

Patients involved in controlled or interventional trials in the 12 previous months

Trial design

299 participants in 1 patient group

1.0

Description:

As per routinary clinical practice

Treatment:

Other: As per clinical practice