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Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis

Information source: Ruhr University of Bochum
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Progression of Rheumatoid Arthritis

Intervention: Prednisolone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Prof. Dr. rer. nat. H.J. Trampisch

Official(s) and/or principal investigator(s):
Juergen Braun, MD, Principal Investigator, Affiliation: Rheumazentrum Ruhrgebiet, Herne/Germany

Overall contact:
Hans J Trampisch, MD, Phone: +49 (0)234-3227790, Email: Hans.J.Trampisch@ruhr-uni-bochum.de


Although cortisone is widely used in the treatment of patients with early rheumatoid arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon starting dosages and placebo in the treatment of patients with early active rheumatoid arthritis on the background of the established therapy with methotrexate. In total 450 patients will be included into the study. Two different treatment arms starting with 10 or 60 mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In parallel, all patients start medication with methotrexate, usual dosage 15 mg/week. Primary efficacy endpoint is progression of radiographic damage after one year compared to baseline. Safety monitoring is performed.

Clinical Details

Official title: Comparison of the Efficacy and Safety of Two Different Starting Dosages of Prednisolone in Early Active Rheumatoid Arthritis: a Randomized, Placebo Controlled Trial

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Progression of radiographic damage after one year as quantified by the van der Heijde modification of the Sharp score (SHS). Determined at baseline and after one year.

Secondary outcome:

Percentage of patients in remission

Changes of functional capacity

Patient's assessment of disease activity

Detailed description: BACKGROUND: Although glucocorticoids (GCs) are widely used in the treatment of patients with early rheumatoid arthritis (RA), the best dosage for GCs, related to both, efficacy and safety, is not known. OBJECTIVE: To compare two standard p. o. GC starting dosages and the non-use of GCs in the treatment of patients with early active RA on the background of the established 'anchor' therapy with methotrexate (MTX). METHODS: Randomised double-blind placebo-controlled trial with two treatment arms (starting with 10 or 60 mg of p. o. prednisolone (P), tapered down to 5 mg P per day within 8 weeks) and one placebo arm, each arm comprising 150 patients. Duration of intervention is 12 weeks. In parallel, all patients start medication with MTX, usual dosage 15 mg/week. Primary efficacy endpoint is progression of radiographic damage after one year compared to baseline. Secondary endpoints are: percentage of patients in remission, changes of functional capacity etc. Safety monitoring is performed. The analysis is performed in three hierarchical steps. First step is an analysis of covariance to compare the group with an initial P dosage of 60 mg (V60) and the placebo group (Pl). In case of a statistical significant result (α = 0. 05), a comparison of the group starting with 10 mg P (V10) and Pl will be done in a second step (α = 0. 05). In case of superiority of V10 versus Pl, a third step will be a non-inferiority test for V10 versus V60 (α = 0. 025).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of rheumatoid arthritis based on expert opinion according to the American

College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2009 criteria (Hawker 2009)

- disease duration < 3 years

- active disease: disease activity score (DAS) 28 erythrocyte sedimentation rate (ESR)

(Prevoo et al 1995) > 4 plus ≥ 3 swollen joints Exclusion Criteria:

- Prior treatment with disease-modifying antirheumatic drugs (DMARDs) (except for

hydroxychloroquine or sulfasalazine or methotrexate during the last four weeks before screening)

- Clinically relevant comorbidity:

- concurrent liver disease (ALT > 2 times upper limit of normal),

- active hepatitis B or C viral infection,

- renal disease (creatinine clearance < 30 ml/minute),

- clinically relevant haematological disease due to the judgement of the


- uncontrolled diabetes mellitus,

- uncontrolled arterial hypertension,

- relevant immunodeficiency incl. HIV-infection,

- clinically significant pulmonary fibrosis,

- history of malignant melanoma,

- complicated or refractory gastrointestinal ulcers,

- presence or history of severe infections,

- uncontrolled increased intraocular pressure,

- pregnancy or planned pregnancy,

- non-compliance,

- age < 18 years

Locations and Contacts

Hans J Trampisch, MD, Phone: +49 (0)234-3227790, Email: Hans.J.Trampisch@ruhr-uni-bochum.de

Rheumatologische Schwerpunktpraxis Bielefeld, Bielefeld 33617, Germany; Recruiting
Albert Schmid, MD, Phone: +49 (0)521-15711, Email: forum.deckertstrasse@bitel.net
Albert Schmid, MD, Principal Investigator
Hans-Joachim Christoph, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Bocholt, Bocholt 46397, Germany; Recruiting
Anna M Hund, MD, Phone: +49 (0)2871-2904200, Email: mhundbocholt@aol.com
Anna M Hund, MD, Principal Investigator
Frank Schumann, MD, Sub-Investigator

MVZ Endokrinologikum Ruhr, Bochum 44866, Germany; Active, not recruiting

Rheumatologische Schwerpunktpraxis Bochum, Bochum 44787, Germany; Recruiting
Manfred Igelmann, MD, Phone: +49 (0)234 60631, Email: rheuma.igelmann@t-online.de
Manfred Igelmann, MD, Principal Investigator
Elmar Schmitz-Bortz, MD, Sub-Investigator

MVZ Dr. Kretzmann und Kollegen, Dortmund 44147, Germany; Recruiting
Ulrich Risse, MD, Phone: +49 (0)231-8602370
Ulrich Risse, MD, Principal Investigator
Manfred Igelmann, MD, Sub-Investigator

Rheumapraxis Dortmund, Dortmund 44137, Germany; Recruiting
Judith Guenzel, Phone: +49 (0)231 95727305, Email: guenzel@labmed.de
Judith Guenzel, Principal Investigator
Annette Rittstieg, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Dortmund, Dortmund 44263, Germany; Recruiting
Hans-Juergen Menne, MD, Phone: +49 (0)231-102535, Email: menne@rheumapraxis-dortmund.de
Hans-Juergen Menne, MD, Principal Investigator
Dietmar Krause, MD, Sub-Investigator

Rheumapraxis Duisburg, Duisburg 47057, Germany; Recruiting
Claas Fendler, MD, Phone: +49 (0)203-2890150, Email: rheumapraxis-duisburg@gmx.de
Claas Fendler, MD, Principal Investigator
Ertan Saracbasi-Zender, MD, Sub-Investigator

Rheumapraxis Gelsenkirchen, Gelsenkirchen 45891, Germany; Active, not recruiting

Internistische und rheumatologische Praxis Gladbeck, Gladbeck 45964, Germany; Recruiting
Dietmar Krause, MD, Phone: +49 (0)2043-206111, Email: gundi.krause@t-online.de
Dietmar Krause, MD, Principal Investigator
Claudia Klink, MD, Sub-Investigator

Facharztzentrum Hagen, Hagen 58089, Germany; Recruiting
Cornelia Schweder, MD, Phone: +49 (0)2331-3757715
Cornelia Schweder, MD, Principal Investigator
Udo Rosendahl, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Hamm, Hamm 59065, Germany; Withdrawn

Orthopädisch-rheumatologische Schwerpunktpraxis, Hattingen 45525, Germany; Recruiting
Juergen Bachmann, MD, Phone: +49 (0)2324-925953, Email: jbachmann@augusta-clinic.de
Juergen Bachmann, MD, Principal Investigator
Elmar Schmitz-Bortz, MD, Sub-Investigator

Rheumapraxis Hattingen, Hattingen 45527, Germany; Recruiting
Elmar Schmitz-Bortz, MD, Phone: +49 (0)2324-919648, Email: esb@rheumapraxis-hattingen.de
Elmar Schmitz-Bortz, MD, Principal Investigator
Manfred Igelmann, MD, Sub-Investigator

Rheumapraxis Herne, Herne 44652, Germany; Recruiting
Friedrich Dybowski, MD, Phone: +49 (0)2323-9190740, Email: empfang@rheumapraxis-ruhr.de
Friedrich Dybowski, MD, Principal Investigator
Ludwig Kalthoff, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Herne, Herne 44623, Germany; Recruiting
Ludwig Kalthoff, MD, Phone: +49 (0)2323-91900740, Email: kalthoff@rheumapraxis-ruhr.de
Ludwig Kalthoff, MD, Principal Investigator
Gunda-Liane Hein, MD, Sub-Investigator

Rheumazentrum Ruhrgebiet, Herne 44652, Germany; Recruiting
Juergen Braun, MD, Phone: +49 (0)2325-592131, Email: j.braun@rheumazentrum-ruhrgebiet.de
Juergen Braun, MD, Principal Investigator
Frank Heldmann, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Lingen, Lingen 49808, Germany; Active, not recruiting

Rheumapraxis am EVK, Lippstadt 59555, Germany; Recruiting
Andreas Goebel, MD, Phone: +49 (0)2941-97575, Email: dr.a.goebel@t-online.de
Andreas Goebel, MD, Principal Investigator
Ernst Scheibl, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Marl, Marl 45768, Germany; Recruiting
Stephanie Boeddeker, MD, Phone: +49 (0)2365-2045720, Email: dr.boeddeker@die-rheuma-praxis.de
Stepahnie Boeddeker, MD, Principal Investigator
Frank Schumann, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Minden, Minden 32425, Germany; Recruiting
Hans-Joachim Christoph, MD, Phone: +49 (0)571-8292007, Email: dr.christoph@rheumapraxis-minden.de
Hans-Joachim Christoph, MD, Principal Investigator
Albert Schmid, MD, Sub-Investigator

Rheumapraxis Mülheim, Mülheim 45468, Germany; Withdrawn

Rheumatologische Schwerpunktpraxis Münster, Münster 48143, Germany; Active, not recruiting

Rheumapraxis Oberhausen, Oberhausen 46145, Germany; Recruiting
Ertan Saracbasi-Zender, MD, Phone: +49 (0)208-74011891, Email: saracbasi@t-online.de
Ertan Saracbasi-Zender, MD, Principal Investigator
Claas Fendler, MD, Sub-Investigator

Rheumapraxis Paderborn, Paderborn 33098, Germany; Active, not recruiting

Rheumatologische Gemeinschaftspraxis Ratingen, Ratingen 40882, Germany; Recruiting
Siegfried Wassenberg, MD, Phone: +49 (0)2102-206233, Email: info@rheumazentrum-ratingen.de
Siegfried Wassenberg, MD, Principal Investigator
Ralf Weier, MD, Sub-Investigator

Rheumatologische Schwerpunktpraxis Reken, Reken 48734, Germany; Withdrawn

Rheumatologische Schwerpunktpraxis Rheine, Rheine 48431, Germany; Recruiting
Ulrich Schoo, MD, Phone: +49 (0)5971-913842, Email: u.schoo@t-online.de
Ulrich Schoo, MD, Principal Investigator
Georg Huebner, MD, Sub-Investigator

Rheumapraxis Schwerte, Schwerte 58239, Germany; Withdrawn

Rheumapraxis Siegen, Siegen 57072, Germany; Withdrawn

Rheumapraxis Warendorf, Warendorf 48231, Germany; Active, not recruiting

Additional Information

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Starting date: January 2014
Last updated: May 5, 2015

Page last updated: August 23, 2015

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