Treatment intensification based on disease activity parameters or on cartilage breakdown markers in early rheumatoid arthritis

Vrije University Medical Centre (VUMC) (The Netherlands)0 sites40 target enrollmentSeptember 12, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 12, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Vrije University Medical Centre (VUMC) (The Netherlands)

•Patients must have:
•1\. Rheumatoid arthritis (American College of Rheumatology \[ACR] criteria met cumulatively)
•2\. Requiring treatment: 28\-item Disease Activity Score (DAS28\) greater than 3\.2
•3\. Propensity for radiographic progression: urinary CTX\-2 greater than 150 ng/µmol creatinine

•1\. Unwillingness to participate in the study and comply with its procedures by signing a written informed consent
•More chance of harm:
•2\. Contraindication to study drugs:
•2\.1\. Previous serious adverse reaction or documented allergy to any of the trial drugs or their constituents
•2\.2\. Previous inability to tolerate sulphasalazine (minimum 1 g/d), hydroxychloroquine (minimum 200 mg/d) methotrexate (minimum 7\.5 mg/week) or oral prednisolone
•3\. Active infection or those at high risk of infection:
•3\.1\. Abnormal chest X\-ray or positive tuberculin test suggestive of previous TB that has not been adequately treated
•3\.2\. Chronic leg ulcers
•3\.3\. Septic arthritis of a native joint within the last 12 months
•3\.4\. Previous prosthetic joint sepsis within the last 12 months, indefinitely if prosthesis remains in situ