Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?

Phase 1

• Conditions: biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy.; MedDRA version: 20.0Level: LLTClassification code 10039076Term: Rheumatoid arthritis and other inflammatory polyarthropathiesSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-005204-15-AT
• Lead Sponsor: Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-15
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1.Male or female patients =18 years and <90 years of age
2.Classification of RA according to the ACR-EULAR 2010 criteria
3.Clinical remission according to ACR-EULAR remission criteria at time of inclusion and remission or low disease activity according to SDAI in the preceding 6 months
4.Written informed consent
5.Current treatment with a csDMARD plus a stable dose and administration interval (for at least 6 months) of a bDMARD
6.No current corticosteroid treatment
7.Stable dose of NSAIDs

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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1.Current treatment with any investigational drug
2.Current administration interval of the bDMARD of >11 weeks
3.Complete destruction of any joint to be investigated by sonography
4.Severe systemic (i.e. extraarticular) RA- manifestation
5.Begin of arthritis before age of 17 years
6.Planned surgery within the study period or history of surgery of any joint to be investigated clinically or by sonography
7.Current severe medical illness requiring hospitalization
8.Active infection or active malignancy
9.Pregnancy or lactation
10.Inability of the patient to follow the protocol
11.Current treatment with Rituximab (MabThera®)

Study & Design

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