Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study

Phase 1

• Conditions: Early Active Rheumatoid Arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-003658-26-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

- RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (13)
- Age of 18 years and older
- Early RA: a diagnosis of RA of less than 2 years

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 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

- Prior treatment DMARDs (except hydroxychloroquine)
- Insulin-dependent Diabetes mellitus
- Uncontrollable non-insuline dependent diabetes mellitus
- Heart failure NYHA class 3-4
- Uncontrollable hypertension
- ALAT/ASAT >3 times normal values
- Reduced renal function (serum creat >125 µmol/l for male and >100 µmol/l for female)
- Contra-indications for methotrexate, sulphasalazine or prednisolone
- Indications of probable tuberculosis
- Increased risk of harm due to contraindications to the study drugs
- Language problems

Study & Design

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