Rheumatoid Arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : Namilumab
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigat
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2.The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3.Is male or female and aged 18 years (20 years in Japan) or older at time of signing the informed consent form. 4.Must have adult onset rheumatoid arthritis (RA) as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for the classification of RA for at least 6 months prior to Screening Visit. 5.Must have active disease defined as: At least moderately active disease defined by DAS28(CRP)>=3.2 at screening and DAS28(ESR) >=3.2 at baseline visit [Day 1] and Swollen joint count (SJC) >=4 (within the 28 joints from DAS28) at both the Screening and baseline [Day 1] Visits. 6.Visual analog scale (VAS) pain > 40 mm as measured using the 100 mm study site electronic VAS scale at the Screening Visit and baseline [Day 1] visit. 7.Currently receiving treatment for Rheumatoid Arthritis (RA) with methotrexate (MTX), and :Has received MTX on a weekly basis for at least 3 months prior to the Baseline (Day 1) Visit AND ;Has received treatment with 15 mg/week ==7.5 mg/week is acceptable, if the MTX dose has been reduced for reasons of documented intolerance to MTX, e.g. hepatic or hematological toxicity documented in Electronic case report form (eCRF), or per local requirement. 8.Willing to continue or initiate treatment with oral folic acid (at least 5 mg/week) or equivalent and be treated during the entire study (mandatory co-medication for MTX treatment). 9.Must have a posterior, anterior (PA) and lateral chest x-ray obtained within 3 months prior to Screening, or recorded during screening. 10.A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study until the end of the safety follow up (18 weeks after last dose). 11.A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of the informed consent throughout the duration of the study until the end of the safety follow up (18 weeks after last dose). 12.Is able and willing to complete questionnaires at home using an electronic device in an approved language. 13.Inadequate response to methotrexate (MTX-IR) participants and tumor necrosis factor (TNF)-inhibitor (TNF-IR) participants.
Exclusion criteria
Exclusion criteria: 1.Participants 1.5 x upper limit of normal (ULN); e) Bilirubin (total) >ULN, unless Gilbert's disease has been determined by genetic testing and has been documented. 9.Has a history of hypersensitivity or allergies to namilumab or any of the contents of the formulation. 10.Has any clinically significant illness, including infection requiring antibiotics, within 4 weeks prior to the first dose of study medication - which may influence the outcome of the study. 11.Has an underlying condition that predisposes to infections (eg, immunodeficiency, poorly controlled diabetes history, splenectomy). 12.Evidence of clinically significant respiratory disease, on the basis of review the data from participants' respiratory assessments, including chest x-ray, lung function tests (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) by spirometry performed at screening). The participants must have Saturation of peripheral oxygen (SpO2) >=94%, FEV1 and FVC >=60 % of predicted values and a Medical Research Council (MRC) Breathlessness Scale score of less than 4 at Screening and at Baseline and no uncontrolled lung disease. A participant's treatment which has been modified to control lung disease within 24 weeks prior to screening is exclusionary. 13.History of clinically significant interstitial lung disease (ILD) eg, history of chronic or recurrent pulmonary infection where macrophages are important for the clearance of the infection eg, pneumocystis carinii pneumonia (PCP), allergic bronchopulmonary aspergillosis (ABPA), nocardia infections, Actinomyces infection, Japanese and Korean patients will be tested using Beta glucans test and participants will be excluded unless the Beta-Glucans test is negative. 14.Presence or history of active tuberculosis (TB) or latent TB infection, where no anti-TB treatment has been given or where successful completion of an appropriate course of anti-TB therapy cannot be documented. 15.A positive QuantiFERON-TB Gold test and/or evidence of active or latent TB by chest X-ray, not accompanied by initiation of an approve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28) at Week 12 Timeframe; Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) and ACRn Response at Weeks 12 and 24 Timeframe; ACR20/50/70 and ACRn response: Baseline, Weeks 12 and 24 Mean Change From Baseline in DAS28-CRP at Week 2, 6 and 24 Timeframe; Baseline, Weeks 2, 6 and 24 Percentage of Participants with a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) Reduction of Pain, defined as more than 40% change from baseline as measured using a Visual Analog Scale (VAS) at weeks 2, 12 and 24. Timeframe; Baseline, Weeks 2, 12 and 24 | — |
Outcome results
None listed