Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis

Phase 1

• Conditions: Early rheumatoid arthritis; MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-004074-25-DE
• Lead Sponsor: Ruhr-Universität Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-29
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Diagnosis of rheumatoid arthritis based on expert opinion according to the ACR/EULAR 2009 criteria (Hawker 2009), disease duration < 3 years, active disease: DAS 28 ESR (Prevoo et al 1995) > 4 plus = 3 swollen joints

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

Prior treatment with DMARDs (except for hydroxychloroquin 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 rheumatologist,
uncontrolled diabetes mellitus,
relevant immunodeficiency incl. HIV-infection,
clinically significant pulmonary fibrosis,
presence or history of severe infections,
pregnancy or planned pregnancy,
non-compliance,
age < 18 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified