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

Inclusion Criteria:

- Patients with a diagnosis of rheumatoid arthritis (RA) as defined by the 2010 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.