Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis (TryCort)
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|ClinicalTrials.gov Identifier: NCT01395251|
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : May 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Prednisolone||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
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 for 2 days.
prednisolone 20 mg once a day per os for 3 subsequent days
Other Name: glucocorticoids
- Rate of true diagnosis of rheumatoid arthritis after positive prednisolone test [ Time Frame: 3 months ]Positive prednisolone test: change of more than 40% (on a NRS 0-100%) in painful joints after 3 days of therapy with prednisolone 20 mg/d
- Rate of true negative diagnosis of rheumatoid arthritis after positive prednisolone test [ Time Frame: 3 months ]Positive prednisolone test: change of more than 40% (on a NRS 0-100%) in painful joints after 3 days of therapy with prednisolone 20 mg/d
- Negative predictive value [ Time Frame: 3 months ]
- Positive predictive value [ Time Frame: 3 months ]
- clinical characteristics of patients with early RA [ Time Frame: 3 months ]
- change of disease activity [ Time Frame: 3 months ]assessed with DAS-28
- change of functioning [ Time Frame: 3 months ]assessed with HAQ
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395251
|Herne, Germany, 44652|
|Principal Investigator:||Juergen Braun, MD||Rheumazentrum Ruhrgebiet, Herne, Germany|