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

Sponsor
Nichi-Iko Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02990806
Collaborator
(none)
683
Enrollment
134
Locations
2
Arms
28.9
Duration (Months)
5.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: NI-071
  • Biological: Infliximab
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
683 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: NI-071

Proposed biosimilar

Biological: NI-071
20 ml vial containing 100 mg for a final reconstitution volume of 10 mg/mL
Other Names:
  • Proposed infliximab biosimilar

    		•
    Active Comparator: Infliximab

    Reference product

    Biological: Infliximab
    20 ml vial containing 100 mg for a final reconstitution volume of 10 mg/mL
    Other Names:
  • Remicade

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 20% improvement from baseline in the American College of Rheumatology (ACR) core set criteria using C-reactive protein (CRP) (ACR20-CRP) [At Week 22]

    2. Area under the plasma concentration-time curve for a dosing interval (AUCtau) [During the dosing interval of Weeks 46 to 54]

    3. Maximum concentration (Cmax) [During the dosing interval of Weeks 46 to 54]

    4. Long-term safety (Incidence of Adverse Events, Incidence of Anti-Drug Antibodies (ADA), etc.) [Through study completion]

    Secondary Outcome Measures

    1. ACR20-CRP (at time points other than Week 22) [up to Week 62]

    2. 20% improvement from baseline in the ACR core set criteria using erythrocyte sedimentation rate (ESR) (ACR20-ESR) [up to Week 62]

    3. 50% improvement from baseline in the ACR core set criteria using CRP (ACR50-CRP) [up to Week 62]

    4. 50% improvement from baseline in the ACR core set criteria using ESR (ACR50-ESR) [up to Week 62]

    5. 70% improvement from baseline in the ACR core set criteria using CRP (ACR70-CRP) [up to Week 62]

    6. 70% improvement from baseline in the ACR core set criteria using ESR (ACR70-ESR) [up to Week 62]

    7. Change from baseline in the disease activity score based on 28 joints (DAS28) [up to Week 62]

    8. Change from baseline in the routine assessment of patient index data 3 (RAPID3) scores [up to Week 62]

    9. Change from baseline in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) [up to Week 62]

    10. Minimum concentration (Cmin) [During the dosing interval of Weeks 46 to 54]

    11. Time at maximum concentration (tmax) [During the dosing interval of Weeks 46 to 54]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nichi-Iko Investigational Site Little Rock Arkansas United States 72205
    2 Nichi-Iko Investigational Site Los Angeles California United States 90017
    3 Nichi-Iko Investigational Site Los Angeles California United States 90036
    4 Nichi-Iko Investigational Site Ventura California United States 93003
    5 Nichi-Iko Investigational Site Whittier California United States 90602
    6 Nichi-Iko Investigational Site Hamden Connecticut United States 06518
    7 Nichi-Iko Investigational Site Boca Raton Florida United States 33486
    8 Nichi-Iko Investigational Site Boynton Beach Florida United States 33472
    9 Nichi-Iko Investigational Site Brandon Florida United States 33511
    10 Nichi-Iko Investigational Site Doral Florida United States 33126
    11 Nichi-Iko Investigational Site Doral Florida United States 33166
    12 Nichi-Iko Investigational Site Hialeah Florida United States 33012
    13 Nichi-Iko Investigational Site Jacksonville Florida United States 32207
    14 Nichi-Iko Investigational Site Miami Lakes Florida United States 33016
    15 Nichi-Iko Investigational Site Miami Florida United States 33032
    16 Nichi-Iko Investigational Site Miami Florida United States 33122
    17 Nichi-Iko Investigational Site Miami Florida United States 33135
    18 Nichi-Iko Investigational Site Miami Florida United States 33147
    19 Nichi-Iko Investigational Site Miami Florida United States 33155
    20 Nichi-Iko Investigational Site Miami Florida United States 33165
    21 Nichi-Iko Investigational Site Miami Florida United States 33174
    22 Nichi-Iko Investigational Site Miami Florida United States 33175
    23 Nichi-Iko Investigational Site Pembroke Pines Florida United States 33024
    24 Nichi-Iko Investigational Site Pembroke Pines Florida United States 33026
    25 Nichi-Iko Investigational Site Pinellas Park Florida United States 33782
    26 Nichi-Iko Investigational Site Sarasota Florida United States 34239
    27 Nichi-Iko Investigational Site West Palm Beach Florida United States 33409
    28 Nichi-Iko Investigational Site Decatur Georgia United States 30030
    29 Nichi-Iko Investigational Site Meridian Idaho United States 83642
    30 Nichi-Iko Investigational Site Lexington Kentucky United States 40504
    31 Nichi-Iko Investigational Site Louisville Kentucky United States 40213
    32 Nichi-Iko Investigational Site Worcester Massachusetts United States 01605
    33 Nichi-Iko Investigational Site Ann Arbor Michigan United States 48109
    34 Nichi-Iko Investigational Site Grand Rapids Michigan United States 49546
    35 Nichi-Iko Investigational Site Lansing Michigan United States 48910
    36 Nichi-Iko Investigational Site Tupelo Mississippi United States 38801
    37 Nichi-Iko Investigational Site Las Vegas Nevada United States 89106
    38 Nichi-Iko Investigational Site Las Vegas Nevada United States 89128
    39 Nichi-Iko Investigational Site Freehold New Jersey United States 07728
    40 Nichi-Iko Investigational Site Durham North Carolina United States 27704
    41 Nichi-Iko Investigational Site Greenville North Carolina United States 27834
    42 Nichi-Iko Investigational Site Salisbury North Carolina United States 28144
    43 Nichi-Iko Investigational Site Wilmington North Carolina United States 28401
    44 Nichi-Iko Investigational Site Cincinnati Ohio United States 45242
    45 Nichi-Iko Investigational Site Columbus Ohio United States 43203
    46 Nichi-Iko Investigational Site Middleburg Heights Ohio United States 44130
    47 Nichi-Iko Investigational Site Oklahoma City Oklahoma United States 73103
    48 Nichi-Iko Investigational Site Oklahoma City Oklahoma United States 73111
    49 Nichi-Iko Investigational Site Oklahoma City Oklahoma United States 73112
    50 Nichi-Iko Investigational Site Duncansville Pennsylvania United States 16635
    51 Nichi-Iko Investigational Site Media Pennsylvania United States 19063
    52 Nichi-Iko Investigational Site Wyomissing Pennsylvania United States 19610
    53 Nichi-Iko Investigational Site Charleston South Carolina United States 29406
    54 Nichi-Iko Investigational Site Fort Mill South Carolina United States 29707
    55 Nichi-Iko Investigational Site Jackson Tennessee United States 38305
    56 Nichi-Iko Investigational Site Memphis Tennessee United States 38119
    57 Nichi-Iko Investigational Site Amarillo Texas United States 79124
    58 Nichi-Iko Investigational Site Baytown Texas United States 77521
    59 Nichi-Iko Investigational Site Beaumont Texas United States 77702
    60 Nichi-Iko Investigational Site Corpus Christi Texas United States 78404
    61 Nichi-Iko Investigational Site Cypress Texas United States 77429
    62 Nichi-Iko Investigational Site El Paso Texas United States 79935
    63 Nichi-Iko Investigational Site Galveston Texas United States 77555
    64 Nichi-Iko Investigational Site Houston Texas United States 77004
    65 Nichi-Iko Investigational Site Houston Texas United States 77034
    66 Nichi-Iko Investigational Site Houston Texas United States 77084
    67 Nichi-Iko Investigational Site Houston Texas United States 77089
    68 Nichi-Iko Investigational Site Houston Texas United States 77094
    69 Nichi-Iko Investigational Site Mesquite Texas United States 75150
    70 Nichi-Iko Investigational Site Nassau Bay Texas United States 77058
    71 Nichi-Iko Investigational Site San Antonio Texas United States 78229
    72 Nichi-Iko Investigational Site Sugar Land Texas United States 77479
    73 Nichi-Iko Investigational Site Tomball Texas United States 77375
    74 Nichi-Iko Investigational Site Webster Texas United States 77598
    75 Nichi-Iko Investigational Site Chesapeake Virginia United States 23320
    76 Nichi-Iko Investigational Site Ostrava Czechia 702 00
    77 Nichi-Iko Investigational Site Praha 2 Czechia 128 51
    78 Nichi-Iko Investigational Site Uherské Hradišté Czechia 686 01
    79 Nichi-Iko Investigational Site Zlin Czechia 760 01
    80 Nichi-Iko Investigational Site Białystok Poland 15-351
    81 Nichi-Iko Investigational Site Katowice Poland 40-282
    82 Nichi-Iko Investigational Site Lublin Poland 20-582
    83 Nichi-Iko Investigational Site Olsztyn Poland 10-117
    84 Nichi-Iko Investigational Site Poznań Poland 60-773
    85 Nichi-Iko Investigational Site Poznań Poland 61-113
    86 Nichi-Iko Investigational Site Toruń Poland 87-100
    87 Nichi-Iko Investigational Site Warsaw Poland 509268
    88 Nichi-Iko Investigational Site Warszawa Poland 00-465
    89 Nichi-Iko Investigational Site Warszawa Poland 00-660
    90 Nichi-Iko Investigational Site Warszawa Poland 02-691
    91 Nichi-Iko Investigational Site Warszawa Poland 03-291
    92 Nichi-Iko Investigational Site Łódź Poland 90-242
    93 Nichi-Iko Investigational Site Łódź Poland 91-363
    94 Nichi-Iko Investigational Site Caguas Puerto Rico 00725
    95 Nichi-Iko Investigational Site San Juan Puerto Rico 00918
    96 Nichi-Iko Investigational Site Kemerovo Russian Federation 650099
    97 Nichi-Iko Investigational Site Moscow Russian Federation 125315
    98 Nichi-Iko Investigational Site Moscow Russian Federation 129327
    99 Nichi-Iko Investigational Site Novosibirsk Russian Federation 630099
    100 Nichi-Iko Investigational Site Penza Russian Federation 440026
    101 Nichi-Iko Investigational Site Petrozavodsk Russian Federation 185019
    102 Nichi-Iko Investigational Site Ryazan Russian Federation 390026
    103 Nichi-Iko Investigational Site Saint Petersburg Russian Federation 190068
    104 Nichi-Iko Investigational Site Saint Petersburg Russian Federation 192242
    105 Nichi-Iko Investigational Site Saint Petersburg Russian Federation 194291
    106 Nichi-Iko Investigational Site Saint Petersburg Russian Federation 197022
    107 Nichi-Iko Investigational Site Tomsk Russian Federation 664046
    108 Nichi-Iko Investigational Site Vladimir Russian Federation 600023
    109 Nichi-Iko Investigational Site Yaroslavl Russian Federation 150003
    110 Nichi-Iko Investigational Site Yaroslavl Russian Federation 150062
    111 Nichi-Iko Investigational Site A Coruña Spain 15006
    112 Nichi-Iko Investigational Site Barcelona Spain 08034
    113 Nichi-Iko Investigational Site Barcelona Spain 80028
    114 Nichi-Iko Investigational Site Santiago de Compostela Spain 15701
    115 Nichi-Iko Investigational Site Santiago de Compostela Spain 15705
    116 Nichi-Iko Investigational Site Sevilla Spain 41010
    117 Nichi-Iko Investigational Site Kharkiv Ukraine 61002
    118 Nichi-Iko Investigational Site Kharkiv Ukraine 61029
    119 Nichi-Iko Investigational Site Kharkov Ukraine 61039
    120 Nichi-Iko Investigational Site Kyiv Ukraine 01601
    121 Nichi-Iko Investigational Site Kyiv Ukraine 04050
    122 Nichi-Iko Investigational Site Kyiv Ukraine 04114
    123 Nichi-Iko Investigational Site Lviv Ukraine 79014
    124 Nichi-Iko Investigational Site Odesa Ukraine 65025
    125 Nichi-Iko Investigational Site Ternopil Ukraine 46002
    126 Nichi-Iko Investigational Site Vinnytsya Ukraine 21000
    127 Nichi-Iko Investigational Site Vinnytsya Ukraine 21018
    128 Nichi-Iko Investigational Site Vinnytsya Ukraine 21029
    129 Nichi-Iko Investigational Site Zaporizhzhya Ukraine 69600
    130 Nichi-Iko Investigational Site Zhytomyr Ukraine 10002
    131 Nichi-Iko Investigational Site Bury St Edmunds United Kingdom IP33 2QZ
    132 Nichi-Iko Investigational Site Gillingham United Kingdom ME7 5NY
    133 Nichi-Iko Investigational Site Leicester United Kingdom LE1 5WW
    134 Nichi-Iko Investigational Site Truro United Kingdom TR1 3LJ

    Sponsors and Collaborators

    • Nichi-Iko Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nichi-Iko Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02990806
    Other Study ID Numbers:
    • NI071F2
    • 2016-001064-11
    First Posted:
    Dec 13, 2016
    Last Update Posted:
    May 18, 2020
    Last Verified:
    May 1, 2020
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Infliximab

    Study Results

    No Results Posted as of May 18, 2020