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Completed

NCT Number: NCT01395251

Diagnostic Value of Oral Prednisolone Test for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pain in wrist and fingers without known diagnosis since more than 6 weeks, minimum of pain on a numerical rating scale 4 (out of 10)

Exclusion criteria

  • rheumatoid arthritis
  • psoriatic arthritis
  • psoriasis vulgaris
  • vasculitis
  • gouty arthritis
  • Current glucocorticoidmedication

Treatment and study plan

Prednisolone

Drug

prednisolone 20 mg once a day per os for 3 subsequent days

Other names: glucocorticoids

Primary outcomes

  1. 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

  2. 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

  3. Negative predictive value

    Time frame: 3 months

  4. Positive predictive value

    Time frame: 3 months

Secondary outcomes

  1. clinical characteristics of patients with early RA

    Time frame: 3 months

  2. change of disease activity

    Time frame: 3 months

    assessed with DAS-28

  3. change of functioning

    Time frame: 3 months

    assessed with HAQ

Sponsors and collaborators

Lead sponsor

Rheumazentrum Ruhrgebiet

Other

Registry information

Official study title

Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis

Acronym: TryCort

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2011
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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