A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: NI-071; Remicade
Intervention description: IV infusion.; IV infusion.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 683.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.