rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Olumiant
Product Name: Olumiant
Pharmaceutical Form: Coated tablet
INN or Proposed INN: BARICITINIB
CAS Number: 1187594-09-7
Sponsors
Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 4, 12, 24 weeks;Main Objective: The main objective of the study is to demonstrate non-inferiority of the response of MSKUS-assessed synovitis (i.e. B-mode and Doppler mode synovitis) to baricitinib treatment, alone plus combined with MTX (arm1 + arm2) vs. etanercept plus MTX (arm 3) in IR-MTX patients. Non-inferiority will be claimed if changes in MSKUS-assessed synovitis with baricitinib (alone and combined with MTX) after 12 weeks of treatment is at least 80% of changes in the etanercept + MTX group in the same period using a non-inferiority test for two means.; Secondary Objective: • To compare the grade of B-mode- and Doppler-detected residual synovitis in IR-MTX RA patients who achieve clinical remission or low disease activity (i.e. DAS28 <3.2) at 4 weeks, 12 weeks and 24 weeks on baricitinib + MTX vs baricitinib monotherapy vs + etanercept + MTX. • To evaluate the predictive value of MSKUS-assessed response to baricitinib (monotherapy and combined with MTX) at week 4 in relation to clinical and MSKUS response at week 12 and 24. • To histologically evaluate synovial biopsies, obtained at baseline (26, 27) in baricitinib + MTX treated patients in comparison to that observed in etanercept + MTX therapy, in correlation with the results obtained by MSKUS studies. The gene expression and synthesis of proinflammatory mediators (TNF, IL6, IL1, COX2, MCP1, pSTAT1, pSTAT2, pSTAT3, SOCS1, SOCS2, SOCS3, pERK, pAKT…) by real-time PCR and Western-Blot techniques will be assessed. ... ; Primary end point(s): Efficacy: The primary outcome considered in this trial is the decrease in join inflammation detected by MSKUS (B-mode and Doppler mode synovitis). Safety: Safety evaluation will be assessed through physical examination, possible adverse events (related or not to the treatment under study) and analytical parameters. Dur | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 4, 12, 24 weeks; Secondary end point(s): Secondary: The secondary endpoints will be: • Time-point of significant change in B-mode and Doppler synovitis according to treatment group (4 weeks, 12 weeks, 24 weeks). • Presence and amount of subclinical B-mode and Doppler synovitis in patients reaching DAS28-defined clinical remission and low disease activity at 4 weeks, 12 weeks and 24 weeks, according to treatment group. • Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) at 4 weeks, 12 weeks and 24 weeks, according to treatment group. • Correlation between presence of MSKUS-assessed synovitis, synovial histological alterations and the presence of proinflammatory citokines (TNF, IL6, IL1, COX2, MCP1, RANKL, OPG…) in serum and synovial tissue, at baseline in all patients and after 12 weeks in patients classified as non-responders, according to treatment group. • Changes in PROMs as assessed by the Health Assessment Questionnaire–Disability Index (HAQ-DI), from baseline to 24 weeks. | — |
Countries
Spain
Contacts
Public ContactTeresa Bricio
Alpha Bioresearch S.L.
Outcome results
None listed