Rheumatoid Arthritis (RA) MedDRA version: 18.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Namilumab
Product Code: MT203
Pharmaceutical Form: Solution for injection
INN or Proposed INN: namilumab
CAS Number: 12066
Sponsors
Takeda Development Centre Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined according to the following criteria prior to entry into the study: The subject is male or female and aged 18 years, or above (=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Subjects 65 years of age in Czech Republic. The subject has received biologic DMARDs for the treatment of RA. The subject has a history of or currently inflammatory joint disease other than RA (eg gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, or Lyme disease) or other systemic autoimmune disorder (eg, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome). The subject has any major systemic features of RA, for example, Felty’s syndrome, vasculitis, or interstitial fibrosis of the lungs. The subject has a history of juvenile idiopathic arthritis or RA onset prior to age 16 years. The subject has an underlying condition that predisposes to infections (eg, immunodeficiency, poorly controlled diabetes history, splenectomy). The subject has a history of clinically significant interstitial lung disease, for example, history of chronic or recurrent pulmonary infection where macrophages are important for the clearance of the infection, for example, pneumocystis jiroveci pneumonia (PJP), formerly known as pneumocystis carinii pneumonia (PCP), allergic bronchopulmonary aspergillosis, nocardia infections, Actinomyces infection. The subject has a positive QuantiFERON-TB Gold test and/or evidence of active or latent TB by chest x-ray at Screening Visit, not accompanied by initiation of an approved regimen of anti-TB therapy at least 12 months prior to the Baseline Visit. The subject has a known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV), or has serological findings at the Screening Visit which indicate active or latent hepatitis B, hepatitis C or HIV infection. The subject has a clinically relevant decrease in lung function at Screening, as defined by an oxygen saturation as measured by pulse oximetry (SpO2) <94% at rest. The subject has evidence of clinically significant respiratory disease on the basis of review the data from subjects’ respiratory assessments including chest x-ray, lung function test (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]) by spirometry performed at Screening). To be eligible for the study, subjects must have SpO2 =94%, FEV1 and/or FVC =60 % of predicted values at Screening or at Baseline and no uncontrolled lung disease. A subject’s treatment that has been modified to control lung disease within 24 weeks prior to Screening is exclusionary. The subject has a history of severe chronic obstructive pulmonary disease (COPD) and/or history of severe COPD exacerbation(s), or a history of asthma with exacerbations requiring hospitalization, within the last 12 months prior to the Screening Visit. The subject has an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m2. The subjects has a history or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the investigator and Takeda physician, would pose a r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect on structural damage image markers measured as change from Baseline in synovitis, erosion, and bone marrow edema (osteitis), in metacarpophalangeal (MCP) joints and wrist at Week 24 on magnetic resonance imaging (MRI) using the RA-MRI scoring (RAMRIS) Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) score.; Secondary Objective: • To explore the effect on structural damage imaging markers measured as change from Baseline in DCE-MRI parameters at Week 24 on MCP joints and wrist using the DCE-MRI. • To explore other clinical efficacy outcomes of namilumab in RA such as Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) and American College of Rheumatology (ACR) 20, 50, and 70 criteria. • To explore the speed of onset of efficacy measured as effect on synovitis, bone marrow edema, erosion (RAMRIS), and synovial perfusion using static and DCE-MRI at Weeks 6 and 12. • To evaluate the safety and tolerability of namilumab/MTX coadministration. ;Primary end point(s): • Change from Baseline in synovitis, erosion and bone marrow edema (osteitis), on MRI of the MCP and wrist using the RAMRIS OMERACT at Week 24.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Please see E.5.2 for timepoints corresponding to each secondary endpoint. ; Secondary end point(s): • Vascular perfusion of the synovium measured as a change from Baseline in DCE-MRI parameters at Week 24. The ability to induce synovial remission (absence of synovial inflammation) will be assessed at Weeks 6 and 12 using static (RAMRIS OMERACT synovitis score) and DCE-MRI parameters. • Proportion of subjects who achieved DAS28-CRP (<2.6) remission at Week 24. • Proportion of subjects who achieved DAS28-CRP (<3.2) low disease activity by at Week 24. • Proportion of subjects who achieved ACR 20, 50, and 70 at Week 24. • Clinical disease activity improvement measured as decrease in DAS28-CRP from Baseline at all applicable postbaseline visits. | — |
Countries
Czech Republic, Estonia, Russian Federation, Spain, United Kingdom
Contacts
Public ContactClinical Study Manager
Takeda Development Centre Europe Ltd.
Outcome results
None listed