Recent onset rheumatoid arthritis (RA) and undifferentiated arthritis (UA)
Conditions
Interventions
Four-monthly evaluations of disease activity score and safety. Medication adjustments by protocol, based on DAS calculation, aimed at DAS 1.6, randomisation to either combination with MTX, SSA, hydrox
Sponsors
Abbott
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients >=18 years of age with either RA according to the revised criteria of the American College of Rheumatology (ACR) (29) of less than two years duration, or UA, suspected by the rheumatologist to have an early presentation of RA; 2. All patients must have at least one (out of 66) swollen joint and at least one other (out of 68) painful joint, and a combined DAS of >1.6; 3. All patients must be DMARD- and corticosteroid naïve.
Exclusion criteria
Exclusion criteria: 1. Previous therapy with DMARDs or with corticosteroids (exception: one dose of parenteral corticosteroids within the last 6 months, but not within the last 2 months, or an oral dose of prednisone of = 3 times normal value); 7. Serum creatinine level > 150 umol/l or estimated creatinin clearance of < 75%; 8. Uncontrolled diabetes mellitus (according to the rheumatologist); 9. Uncontrolled hypertension (according to the rheumatologist); 10. Heart failure (NYHA functional class III or IV); 11. Alcohol or drug abuse; 12. History of infected joint prothesis within the previous 3 months; 13. Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; 14. Chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis; 15. History of active tuberculosis requiring treatment within previous 3 years, or signs and symptoms of latent infection with tuberculosis, based on medical history, physical examination, PPD skin test, X-thorax; 16. History of opportunistic infections such as herpes zoster within previous 2 months; 17. Evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium infection etc; 18. Evidence of hepatitis B infection; 19. Documented HIV infection, AIDS related complex (ARC) or AIDS; 20. History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease; 21. Multiple sclerosis or neurological symptoms suspect for demyelinizing disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients in remission (DAS <1.6), functional ability as measured by HAQ, radiological damage progression as measured by Sharp/van der Heijde score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, as measured with MACTAR, SF-36, EuroQol, Time-trade-off. Costs. ACR arthritis core-set. | — |
Contacts
Public ContactC.F. Allaart
Leiden University Medical Center (LUMC), Department of Rheumatology, C1-39, P.O. Box 9600
Outcome results
None listed