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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990806
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date May 18, 2020
Study Start Date  ICMJE December 2016
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • 20% improvement from baseline in the American College of Rheumatology (ACR) core set criteria using C-reactive protein (CRP) (ACR20-CRP) [ Time Frame: At Week 22 ]
  • Area under the plasma concentration-time curve for a dosing interval (AUCtau) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]
  • Maximum concentration (Cmax) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]
  • Long-term safety (Incidence of Adverse Events, Incidence of Anti-Drug Antibodies (ADA), etc.) [ Time Frame: Through study completion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • ACR20-CRP (at time points other than Week 22) [ Time Frame: up to Week 62 ]
  • 20% improvement from baseline in the ACR core set criteria using erythrocyte sedimentation rate (ESR) (ACR20-ESR) [ Time Frame: up to Week 62 ]
  • 50% improvement from baseline in the ACR core set criteria using CRP (ACR50-CRP) [ Time Frame: up to Week 62 ]
  • 50% improvement from baseline in the ACR core set criteria using ESR (ACR50-ESR) [ Time Frame: up to Week 62 ]
  • 70% improvement from baseline in the ACR core set criteria using CRP (ACR70-CRP) [ Time Frame: up to Week 62 ]
  • 70% improvement from baseline in the ACR core set criteria using ESR (ACR70-ESR) [ Time Frame: up to Week 62 ]
  • Change from baseline in the disease activity score based on 28 joints (DAS28) [ Time Frame: up to Week 62 ]
  • Change from baseline in the routine assessment of patient index data 3 (RAPID3) scores [ Time Frame: up to Week 62 ]
  • Change from baseline in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) [ Time Frame: up to Week 62 ]
  • Minimum concentration (Cmin) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]
  • Time at maximum concentration (tmax) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis (RA)
Intervention  ICMJE
  • Biological: NI-071
    20 ml vial containing 100 mg for a final reconstitution volume of 10 mg/mL
    Other Name: Proposed infliximab biosimilar
  • Biological: Infliximab
    20 ml vial containing 100 mg for a final reconstitution volume of 10 mg/mL
    Other Name: Remicade
Study Arms  ICMJE
  • Experimental: NI-071
    Proposed biosimilar
    Intervention: Biological: NI-071
  • Active Comparator: Infliximab
    Reference product
    Intervention: Biological: Infliximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2019)
683
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2016)
585
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990806
Other Study ID Numbers  ICMJE NI071F2
2016-001064-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nichi-Iko Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Nichi-Iko Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nichi-Iko Pharmaceutical Co., Ltd.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP