Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis (TryCort)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Jürgen Braun, Rheumazentrum Ruhrgebiet
ClinicalTrials.gov Identifier:
NCT01395251
First received: July 12, 2011
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: Prednisolone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Rheumazentrum Ruhrgebiet:

Primary Outcome Measures:
  • Rate of true diagnosis of rheumatoid arthritis after positive prednisolone test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Positive predictive value [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical characteristics of patients with early RA [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • change of disease activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    assessed with DAS-28

  • change of functioning [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    assessed with HAQ


Estimated Enrollment: 130
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Prednisolone
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.
Drug: Prednisolone
prednisolone 20 mg once a day per os for 3 subsequent days
Other Name: glucocorticoids

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395251

Locations
Germany
Rheumazentrum Ruhrgebiet
Herne, Germany, 44652
Sponsors and Collaborators
Rheumazentrum Ruhrgebiet
Investigators
Principal Investigator: Juergen Braun, MD Rheumazentrum Ruhrgebiet, Herne, Germany
  More Information

Publications:
Responsible Party: Prof. Dr. med. Jürgen Braun, Professor of Rheuamtology, Rheumazentrum Ruhrgebiet
ClinicalTrials.gov Identifier: NCT01395251     History of Changes
Other Study ID Numbers: TryCort
Study First Received: July 12, 2011
Last Updated: May 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Rheumazentrum Ruhrgebiet:
rheumatoid arthritis
diagnosis
sensitivity
glucocorticoids

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glucocorticoids
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone acetate
Prednisolone acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on August 28, 2014