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

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ClinicalTrials.gov Identifier: NCT02990806
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co., Ltd.

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
Rheumatoid Arthritis (RA) Biological: NI-071 Biological: Infliximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 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 : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

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 Name: 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 Name: Remicade




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) [ Time Frame: At Week 22 ]
  2. Area under the plasma concentration-time curve for a dosing interval (AUCtau) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]
  3. Maximum concentration (Cmax) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]
  4. Long-term safety (Incidence of Adverse Events, Incidence of Anti-Drug Antibodies (ADA), etc.) [ Time Frame: Through study completion ]

Secondary Outcome Measures :
  1. ACR20-CRP (at time points other than Week 22) [ Time Frame: up to Week 62 ]
  2. 20% improvement from baseline in the ACR core set criteria using erythrocyte sedimentation rate (ESR) (ACR20-ESR) [ Time Frame: up to Week 62 ]
  3. 50% improvement from baseline in the ACR core set criteria using CRP (ACR50-CRP) [ Time Frame: up to Week 62 ]
  4. 50% improvement from baseline in the ACR core set criteria using ESR (ACR50-ESR) [ Time Frame: up to Week 62 ]
  5. 70% improvement from baseline in the ACR core set criteria using CRP (ACR70-CRP) [ Time Frame: up to Week 62 ]
  6. 70% improvement from baseline in the ACR core set criteria using ESR (ACR70-ESR) [ Time Frame: up to Week 62 ]
  7. Change from baseline in the disease activity score based on 28 joints (DAS28) [ Time Frame: up to Week 62 ]
  8. Change from baseline in the routine assessment of patient index data 3 (RAPID3) scores [ Time Frame: up to Week 62 ]
  9. Change from baseline in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) [ Time Frame: up to Week 62 ]
  10. Minimum concentration (Cmin) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]
  11. Time at maximum concentration (tmax) [ Time Frame: During the dosing interval of Weeks 46 to 54 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990806


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Sponsors and Collaborators
Nichi-Iko Pharmaceutical Co., Ltd.

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Responsible Party: Nichi-Iko Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02990806     History of Changes
Other Study ID Numbers: NI071F2
2016-001064-11 ( EudraCT Number )
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents