Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis

NCT01395251 | Completed Phase 2 DMC

• 1 other identifier: TryCort
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; diagnosis; sensitivity; glucocorticoids

Outcome Measures

Primary Outcomes (4)

• 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

  3 months

• 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

  3 months

• Negative predictive value

  3 months

• Positive predictive value

  3 months

Secondary Outcomes (3)

• clinical characteristics of patients with early RA

  3 months

• change of disease activity

  3 months

• change of functioning

  3 months

Study Arms (1)

Prednisolone

OTHER

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

Interventions

Prednisolone DRUG

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

Also known as: glucocorticoids

Prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Rheumazentrum Ruhrgebiet: lead

Study Sites (1)

Rheumazentrum Ruhrgebiet

Herne, 44652, Germany

Location

Related Publications (4)

• 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.

  PMID: 20872595 BACKGROUND

• 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.

  PMID: 16255011 BACKGROUND

• 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.

  PMID: 7791815 BACKGROUND

• 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.

  PMID: 28388956 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Disease; Hypersensitivity

Interventions

Prednisolone; Glucocorticoids

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Juergen Braun, MD

  Rheumazentrum Ruhrgebiet, Herne, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheuamtology

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 15, 2011
• Study Start: February 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

DE (1)