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Rheumatoid ArthritisPhase 2/3TryCortNCT01395251

Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis

A Phase 2/3 study testing Prednisolone in people with Rheumatoid Arthritis, run by Rheumazentrum Ruhrgebiet at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteGermany
Study dates
Feb 2012to Dec 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Rheumazentrum Ruhrgebiet

    Herne, 44652

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Prednisolone
Keywords
rheumatoid arthritis, diagnosis, sensitivity, glucocorticoids
Medical subject headings
Arthritis, Rheumatoid, Disease, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoloneDrug

    Also called glucocorticoids

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

Study groups in NCT01395251
Study groupRoleWhat they receive
PrednisoloneOtherPatients 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.
Receives: Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months

  2. 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

    Measured: 3 months

  3. Negative predictive value

    Measured: 3 months

  4. Positive predictive value

    Measured: 3 months

Secondary outcomes (3)

  1. clinical characteristics of patients with early RA

    Measured: 3 months

  2. change of disease activity

    assessed with DAS-28

    Measured: 3 months

  3. change of functioning

    assessed with HAQ

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionNov 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01395251
Sponsor's protocol ID
TryCort
Acronym
TryCort
Status last verified
May 2015
First submitted
12 Jul 2011
Last updated
18 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20872595

  • 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.

    PubMed 16255011

  • 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.

    PubMed 7791815

  • 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.

    PubMed 28388956

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prednisolone in people with Rheumatoid Arthritis, run by Rheumazentrum Ruhrgebiet at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of true diagnosis of rheumatoid arthritis after positive prednisolone test (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01395251, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.

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