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



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:December 2016
End Date:February 2019

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A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis

The purpose of this study is to demonstrate similarity of NI-071 (proposed biosimilar to
infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in patients
with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).


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.
We found this trial at
59
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Ann Arbor, Michigan 48109
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Amarillo, Texas 79124
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Baytown, Texas 77521
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Beaumont, Texas 77702
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Boca Raton, Florida 33486
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Boynton Beach, Florida 33472
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Brandon, Florida 33511
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Charleston, South Carolina 29406
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Chesapeake, Virginia 23320
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Cincinnati, Ohio 45242
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Columbus, Ohio 43203
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Corpus Christi, Texas 78404
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Cypress, Texas 77429
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Decatur, Georgia 30030
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Doral, Florida 33126
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Doral, FL
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Duncansville, Pennsylvania 16635
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Durham, North Carolina 27704
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El Paso, Texas 79935
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El Paso, TX
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Fort Mill, South Carolina 29707
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Fort Mill, SC
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Freehold, New Jersey 07728
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Galveston, Texas 77555
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Grand Rapids, Michigan 49546
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Greenville, North Carolina 27834
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Hamden, Connecticut 06518
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Hialeah, Florida 33012
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Houston, Texas 77004
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Jackson, Tennessee 38305
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Jacksonville, Florida 32207
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Lansing, Michigan 48910
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Las Vegas, Nevada 89106
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Lexington, Kentucky 40504
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Little Rock, Arkansas 72205
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Los Angeles, California 90017
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Louisville, Kentucky 40213
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Media, Pennsylvania 19063
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Memphis, Tennessee 38119
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Meridian, Idaho 83642
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Mesquite, Texas 75150
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Miami, Florida 33032
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Miami Lakes, Florida 33016
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Middleburg Heights, Ohio 44130
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Nassau Bay, Texas 77058
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Oklahoma City, Oklahoma 73103
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Pembroke Pines, Florida 33024
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Pinellas Park, Florida 33782
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Salisbury, North Carolina 28144
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San Antonio, Texas 78229
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Sarasota, Florida 34239
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Sugar Land, Texas 77479
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Tomball, Texas 77375
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Tupelo, Mississippi 38801
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Ventura, California 93003
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Webster, Texas 77598
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West Palm Beach, Florida 33409
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Whittier, California 90602
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Wilmington, North Carolina 28401
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Worcester, Massachusetts 01605
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Wyomissing, Pennsylvania 19610
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