Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.

Phase 1

• Conditions: rheumatoid arthritis; MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-004558-30-ES
• Lead Sponsor: Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 186

Inclusion Criteria

1.Patient able to provide informed consent
2.Mentally competent to understand and willing to undergo the scheduled study procedures, including study questionnaires as established in the protocol.
3.Female or male, from 18 to 75 years of age at the moment of informed consent signature.
4.Patient with RA diagnosed according to 2010 ACR/EULAR Classification Criteria for RA.
5.Moderate to severe disease activity (according to Disease Activity Score for 28 joints (DAS28) = 3.2).
6.Inadequate response to MTX, which must have been received during, at least, 3 months prior to baseline visit and be on a stable dose of = 25 mg/week.
7. Patients who fulfils the pre-requisites for biologic and targeted synthetic disease modifying antirheumatic drugs (DMARD) therapy according to National recommendations/regulations (eg, absence of active infections, absence of latent tuberculosis, recommendations regarding previous cancer, vaccination recommendations.
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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1.Patient considered by the investigator to be unsuitable for the study treatment and/or rescue medication (RM) based on the prescription drug labeling, their medical history, physical examination, concomitant medication (CM) and concomitant systemic diseases.
2.Complications during the period prior to randomisation, in the investigator's opinion.
3.Hypersensitivity or allergy to the study medication.
4.Patients taking any concomitant medication, which could be susceptible to interact with the study medication.
5.Patients in treatment with any medication that could affect the evaluation of the study treatment’s efficacy.
6.Patients on anticoagulant treatment
7.Pregnant or lactating women.

Study & Design

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