A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)

• Status: Completed
• Trial end date: 2019-05-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nichi-Iko Pharmaceutical Co., Ltd.
• Treatments: Infliximab

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.