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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Prednisolone
Sponsored by
Rheumazentrum Ruhrgebiet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, diagnosis, sensitivity, glucocorticoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumazentrum Ruhrgebiet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prednisolone

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of true diagnosis of rheumatoid arthritis after positive prednisolone test
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
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
Positive predictive value

Secondary Outcome Measures

clinical characteristics of patients with early RA
change of disease activity
assessed with DAS-28
change of functioning
assessed with HAQ

Full Information

First Posted
July 12, 2011
Last Updated
May 15, 2015
Sponsor
Rheumazentrum Ruhrgebiet
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1. Study Identification

Unique Protocol Identification Number
NCT01395251
Brief Title
Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis
Acronym
TryCort
Official Title
Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rheumazentrum Ruhrgebiet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, diagnosis, sensitivity, glucocorticoids

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
glucocorticoids
Intervention Description
prednisolone 20 mg once a day per os for 3 subsequent days
Primary Outcome Measure Information:
Title
Rate of true diagnosis of rheumatoid arthritis after positive prednisolone test
Description
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
Time Frame
3 months
Title
Rate of true negative diagnosis of rheumatoid arthritis after positive prednisolone test
Description
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
Time Frame
3 months
Title
Negative predictive value
Time Frame
3 months
Title
Positive predictive value
Time Frame
3 months
Secondary Outcome Measure Information:
Title
clinical characteristics of patients with early RA
Time Frame
3 months
Title
change of disease activity
Description
assessed with DAS-28
Time Frame
3 months
Title
change of functioning
Description
assessed with HAQ
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Braun, MD
Organizational Affiliation
Rheumazentrum Ruhrgebiet, Herne, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44652
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20872595
Citation
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
Results Reference
background
PubMed Identifier
16255011
Citation
Wassenberg S, Rau R, Steinfeld P, Zeidler H. Very low-dose prednisolone in early rheumatoid arthritis retards radiographic progression over two years: a multicenter, double-blind, placebo-controlled trial. Arthritis Rheum. 2005 Nov;52(11):3371-80. doi: 10.1002/art.21421.
Results Reference
background
PubMed Identifier
7791815
Citation
Kirwan JR. The effect of glucocorticoids on joint destruction in rheumatoid arthritis. The Arthritis and Rheumatism Council Low-Dose Glucocorticoid Study Group. N Engl J Med. 1995 Jul 20;333(3):142-6. doi: 10.1056/NEJM199507203330302.
Results Reference
background
PubMed Identifier
28388956
Citation
Kiltz U, von Zabern C, Baraliakos X, Heldmann F, Mintrop B, Sarholz M, Krause D, Dybowski F, Kalthoff L, Braun J. Diagnostic value of a 3-day course of prednisolone in patients with possible rheumatoid arthritis - the TryCort study. Arthritis Res Ther. 2017 Apr 7;19(1):73. doi: 10.1186/s13075-017-1279-z.
Results Reference
derived

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Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis

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