a phase 3 study of ni-071 in participants with rheumatoid arthritis (radiance)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study was to demonstrate similarity of ni-071 (proposed biosimilar to infliximab) to us remicade® (reference product) in terms of safety and efficacy in participants with rheumatoid arthritis (ra) not adequately responding to methotrexate (mtx).


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of rheumatoid arthritis (ra) as defined by the 2010 american college of rheumatology (acr) and european league against rheumatism (eular) classification criteria. * patients have active ra, as confirmed by the following criteria: * ≥6 swollen joints and ≥6 tender joints at screening and baseline (28-joint count). * either c-reactive protein (crp) ≥0.7 mg/dl (≥7.0 mg/l) or erythrocyte sedimentation rate (esr) ≥28 mm/h at screening. * patients taking methotrexate (mtx) (oral or parenteral) for at least 3 months prior to screening and at a stable dose of between 10 and 25 mg/week for at least 8 weeks. concomitant folic/folinic acid at a dose of at least 5 mg/week is to be taken during the study; patients can start treatment with folic/folinic acid at screening if not already receiving it. * if the patient is currently taking non-steroidal anti-inflammatory drugs (nsaids), the patient must be on a stable dose for at least 4 weeks prior to screening and during the study. * patients who are ≥18 and ≤75 years of age at screening. exclusion criteria: * patients who are rated as class iv according to the 1991 acr revised criteria for classification of global functional status for ra. * patients who have received disease-modifying anti rheumatic drugs (dmards), other than mtx, within a period prior to screening shorter than the washout period appropriate to the pharmacodynamic profile of the specific drug. * patients who have received immunosuppressive drugs within 4 weeks prior to screening. patients on a stable dose of oral corticosteroids (≤10 mg/day prednisone or equivalent) for ≥4 weeks prior to screening are permitted. * patients who have received intra-articular, intramuscular, intravenous, or epidural injection of corticosteroids within 4 weeks prior to screening. * patients who have received intra-articular sodium hyaluronate injections within 4 weeks prior to screening. * patients who have received surgical therapy for ra such as synovectomy or arthroplasty within 6 months prior to screening. * patients who have received arthrocentesis within 4 weeks prior to screening. * patients who have had prior treatment with infliximab. * patients who have had prior treatment with \>1 biological drug or \>1 protein kinase inhibitor for ra either as part of clinical management or during a clinical study. * patients who have had prior treatment with tumor necrosis factor alpha (tnf-α) inhibitors for ra who had lack of efficacy as per clinical judgment (primary failure). patients who have discontinued tnf-α inhibitors for ra (other than infliximab) for any reason other than lack of efficacy are allowed. * presence of chronic or acute infection at screening, including positive result for active tuberculosis (tb). * patients with an acute infection requiring parenteral antibiotics within 4 weeks of study dosing or requiring oral/topical antibiotics within 2 weeks of study dosing.