CAMERA
Trial question
What is the effect of intensive treatment with methotrexate in patients with early rheumatoid arthritis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
67.0% female
33.0% male
N = 299
299 patients (201 female, 98 male).
Inclusion criteria: patients with early rheumatoid arthritis.
Key exclusion criteria: previous use of corticosteroids or any DMARD, use of cytotoxic or immunosuppressive drugs within a period of three months before inclusion, alcohol abuse (> 2 units per day), and psychological problems.
Interventions
N=151 intensive methotrexate adjustment (tailored to the individual patient on the basis of predefined response criteria with monthly outpatient visits).
N=148 conventional methotrexate adjustment (according to common practice, outpatient visit once every 3 months).
Primary outcome
Percentage of patients achieving remission at least once at 2 years
50%
37%
50.0 %
37.5 %
25.0 %
12.5 %
0.0 %
Intensive methotrexate
adjustment
Conventional methotrexate
adjustment
Significant
increase ▲
NNT = 7
Significant increase in the percentage of patients achieving remission at least once at 2 years (50% vs. 37%; RR 1.35, 95% CI 0.14 to 2.56).
Secondary outcomes
Significantly shorter time to remission (10.4 months vs. 14.3 months; ARD -3.9, 95% CI -6.21 to -1.59).
Significant decrease in morning stiffness (17 min vs. 23.7 min; MD -6.7, 95% CI -11.73 to -1.67).
Significant decrease in tender joint count (3.6 vs. 5.5; MD -1.9, 95% CI -3.03 to -0.77).
Safety outcomes
No significant differences in adverse events, including gastrointestinal (24.6% vs. 25.2%), neurological disorders (18.8% vs. 18.8%), renal events (2.4% vs. 2.8%).
Conclusion
In patients with early rheumatoid arthritis, intensive methotrexate adjustment was superior to conventional methotrexate adjustment with respect to the percentage of patients achieving remission at least once at 2 years.
Reference
Verstappen SM, Jacobs JW, van der Veen MJ et al. Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial). Ann Rheum Dis. 2007 Nov;66(11):1443-9.
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