Rheumatoid Arthritis Clinical Trial
Official title:
Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory joint disease often leading to progressive joint
destruction. To prevent disability caused by inflamed joints early diagnosis is important.
Early diagnosis might be a challenge because the diagnosis is mostly based on clinical signs
like swelling of small joints. In clinical practice a therapy with prednisolone is started
although the patients do not have an exact diagnosis. In this cases the prednisolone might
serve as a diagnostic test for an inflammatory process.
The objective of this study is to investigate the diagnostic value of oral prednisolone test
for rheumatoid arthritis.
Rheumatoid arthritis is with a prevalence of 2% an important inflammatory joint disease
which often leads to impaired functioning and reduced quality of life. Early diagnosis is an
important step forward to prevent progressive joint destruction. The classification criteria
for rheumatoid arthritis published in 2010 are based on clinical signs (such as swelling)
and laboratory findings (such as rheumatoid factor) (Aletaha D 2010). Because its diagnosis
is based on clinical signs the early diagnosis for rheumatoid arthritis might be a challenge
in daily clinical care.
In clinical practice a therapy with prednisolone is started although the patients do not
have an exact diagnosis. It has been shown that the start of early low-dose prednisolone
decreases the rate of joint destruction after two years of therapy (Kirwan JR 1995,
Wassenberg S 2005). Thus, prednisolone might have effects comparable to that of
disease-modifying antirheumatic drugs.
The objective of this study is to investigate the diagnostic value of oral prednisolone test
for rheumatoid arthritis. The hypothesis is that in patients with rheumatoid arthritis the
prednisolone test will be positive in 80% of the patients whereas positive in just 20% of
patients with osteoarthritis of the hand. Positive prednisolone test is defined as a 30%
improvement of the symptoms in finger and wrist on a numeric rating scale from 0-100.
Patients with suspicious of rheumatoid arthritis will undergo a prednisolone test with 20 mg
per day for 3 days after 2 days of therapy with paracetamol 500 mg twice. After this period
the patients will be asked to rate their benefit in improving pain and reducing swelling of
wrist and finger joints on a numeric rating scale (0-100 % improvement in steps of 20%). A
positive response In addition, demographics and clinical parameter including the compound
measure for disease activity DAS-28 will be collected. A patient with a positive
prednisolone test will receive standard care for rheumatoid arthritis onward. Patients with
a negative prednisolone test will receive standard care for hand and finger osteoarthritis
onward. At week 12 all patients will be seen again to reassess the former diagnosis.
;
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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