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

NCT ID: NCT02990806

Last Updated: 2023-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

683 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-19

Study Completion Date

2019-05-20

Brief Summary

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

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Stages 1, 2 and 3: NI-071 Group

Participants received intravenous (IV) infusion of NI-071 at a dose of 3 milligrams/kilograms (mg/kg) at Weeks 0, 2, 6, 14 during stage 1 and at Weeks 22, 30, 38, 46, and 54 during stage 2. Participants were followed up to Week 62 (Stage 3).

Group Type EXPERIMENTAL

NI-071

Intervention Type DRUG

IV infusion.

Stage 1: Remicade-US Group

Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.

Group Type EXPERIMENTAL

Remicade

Intervention Type DRUG

IV infusion.

Stage 2 and Stage 3: Remicade US to Remicade-US Group

Participants who received Remicade US during stage 1; were re-randomized during stage 2 to continue Remicade-US dose 3 mg/kg from Week 22 through Week 54 with every 8 weeks dosing intervals. Participants were followed up to Week 62 (Stage 3).

Group Type EXPERIMENTAL

Remicade

Intervention Type DRUG

IV infusion.

Stage 2 and Stage 3: Remicade US to Switch Group

Participants who received Remicade US during stage 1; were re-randomized during stage 2 and received IV infusion of NI-071 at Week 22 followed by Remicade-US at Week 30, followed by NI-071 at Weeks 38, 46, and 54. Participants were followed up to week 62 (Stage 3).

Group Type EXPERIMENTAL

NI-071

Intervention Type DRUG

IV infusion.

Remicade

Intervention Type DRUG

IV infusion.

Interventions

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NI-071

IV infusion.

Intervention Type DRUG

Remicade

IV infusion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of rheumatoid arthritis (RA) as defined by the 2010 American College of Rheumatology (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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nichi-Iko Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nichi-Iko Investigational Site

Little Rock, Arkansas, United States

Site Status

Nichi-Iko Investigational Site

Los Angeles, California, United States

Site Status

Nichi-Iko Investigational Site

Los Angeles, California, United States

Site Status

Nichi-Iko Investigational Site

Ventura, California, United States

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Nichi-Iko Investigational Site

Whittier, California, United States

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Nichi-Iko Investigational Site

Hamden, Connecticut, United States

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Nichi-Iko Investigational Site

Boca Raton, Florida, United States

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Nichi-Iko Investigational Site

Boynton Beach, Florida, United States

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Nichi-Iko Investigational Site

Brandon, Florida, United States

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Nichi-Iko Investigational Site

Doral, Florida, United States

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Nichi-Iko Investigational Site

Doral, Florida, United States

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Nichi-Iko Investigational Site

Hialeah, Florida, United States

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Nichi-Iko Investigational Site

Jacksonville, Florida, United States

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Nichi-Iko Investigational Site

Miami, Florida, United States

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Nichi-Iko Investigational Site

Miami, Florida, United States

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Nichi-Iko Investigational Site

Miami, Florida, United States

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Nichi-Iko Investigational Site

Miami, Florida, United States

Site Status

Nichi-Iko Investigational Site

Miami, Florida, United States

Site Status

Nichi-Iko Investigational Site

Miami, Florida, United States

Site Status

Nichi-Iko Investigational Site

Miami, Florida, United States

Site Status

Nichi-Iko Investigational Site

Miami, Florida, United States

Site Status

Nichi-Iko Investigational Site

Miami Lakes, Florida, United States

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Nichi-Iko Investigational Site

Pembroke Pines, Florida, United States

Site Status

Nichi-Iko Investigational Site

Pembroke Pines, Florida, United States

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Nichi-Iko Investigational Site

Pinellas Park, Florida, United States

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Nichi-Iko Investigational Site

Sarasota, Florida, United States

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Nichi-Iko Investigational Site

West Palm Beach, Florida, United States

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Nichi-Iko Investigational Site

Decatur, Georgia, United States

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Nichi-Iko Investigational Site

Meridian, Idaho, United States

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Nichi-Iko Investigational Site

Lexington, Kentucky, United States

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Nichi-Iko Investigational Site

Louisville, Kentucky, United States

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Nichi-Iko Investigational Site

Worcester, Massachusetts, United States

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Nichi-Iko Investigational Site

Ann Arbor, Michigan, United States

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Nichi-Iko Investigational Site

Grand Rapids, Michigan, United States

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Nichi-Iko Investigational Site

Lansing, Michigan, United States

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Nichi-Iko Investigational Site

Tupelo, Mississippi, United States

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Nichi-Iko Investigational Site

Las Vegas, Nevada, United States

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Nichi-Iko Investigational Site

Las Vegas, Nevada, United States

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Nichi-Iko Investigational Site

Freehold, New Jersey, United States

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Nichi-Iko Investigational Site

Durham, North Carolina, United States

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Nichi-Iko Investigational Site

Greenville, North Carolina, United States

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Nichi-Iko Investigational Site

Salisbury, North Carolina, United States

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Nichi-Iko Investigational Site

Wilmington, North Carolina, United States

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Nichi-Iko Investigational Site

Cincinnati, Ohio, United States

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Nichi-Iko Investigational Site

Columbus, Ohio, United States

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Nichi-Iko Investigational Site

Middleburg Heights, Ohio, United States

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Nichi-Iko Investigational Site

Oklahoma City, Oklahoma, United States

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Nichi-Iko Investigational Site

Oklahoma City, Oklahoma, United States

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Nichi-Iko Investigational Site

Oklahoma City, Oklahoma, United States

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Nichi-Iko Investigational Site

Duncansville, Pennsylvania, United States

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Nichi-Iko Investigational Site

Media, Pennsylvania, United States

Site Status

Nichi-Iko Investigational Site

Wyomissing, Pennsylvania, United States

Site Status

Nichi-Iko Investigational Site

Charleston, South Carolina, United States

Site Status

Nichi-Iko Investigational Site

Fort Mill, South Carolina, United States

Site Status

Nichi-Iko Investigational Site

Jackson, Tennessee, United States

Site Status

Nichi-Iko Investigational Site

Memphis, Tennessee, United States

Site Status

Nichi-Iko Investigational Site

Amarillo, Texas, United States

Site Status

Nichi-Iko Investigational Site

Baytown, Texas, United States

Site Status

Nichi-Iko Investigational Site

Beaumont, Texas, United States

Site Status

Nichi-Iko Investigational Site

Corpus Christi, Texas, United States

Site Status

Nichi-Iko Investigational Site

Cypress, Texas, United States

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Nichi-Iko Investigational Site

El Paso, Texas, United States

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Nichi-Iko Investigational Site

Galveston, Texas, United States

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Nichi-Iko Investigational Site

Houston, Texas, United States

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Nichi-Iko Investigational Site

Houston, Texas, United States

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Nichi-Iko Investigational Site

Houston, Texas, United States

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Nichi-Iko Investigational Site

Houston, Texas, United States

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Nichi-Iko Investigational Site

Houston, Texas, United States

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Nichi-Iko Investigational Site

Mesquite, Texas, United States

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Nichi-Iko Investigational Site

Nassau Bay, Texas, United States

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Nichi-Iko Investigational Site

San Antonio, Texas, United States

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Nichi-Iko Investigational Site

Sugar Land, Texas, United States

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Nichi-Iko Investigational Site

Tomball, Texas, United States

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Nichi-Iko Investigational Site

Webster, Texas, United States

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Nichi-Iko Investigational Site

Chesapeake, Virginia, United States

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Nichi-Iko Investigational Site

Ostrava, , Czechia

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Nichi-Iko Investigational Site

Prague, , Czechia

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Nichi-Iko Investigational Site

Uherské Hradišté, , Czechia

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Nichi-Iko Investigational Site

Zlín, , Czechia

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Nichi-Iko Investigational Site

Bialystok, , Poland

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Nichi-Iko Investigational Site

Katowice, , Poland

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Nichi-Iko Investigational Site

Lodz, , Poland

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Nichi-Iko Investigational Site

Lodz, , Poland

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Nichi-Iko Investigational Site

Lublin, , Poland

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Nichi-Iko Investigational Site

Olsztyn, , Poland

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Nichi-Iko Investigational Site

Poznan, , Poland

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Nichi-Iko Investigational Site

Poznan, , Poland

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Nichi-Iko Investigational Site

Torun, , Poland

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Nichi-Iko Investigational Site

Warsaw, , Poland

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Nichi-Iko Investigational Site

Warsaw, , Poland

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Nichi-Iko Investigational Site

Warsaw, , Poland

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Nichi-Iko Investigational Site

Warsaw, , Poland

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Nichi-Iko Investigational Site

Warsaw, , Poland

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Nichi-Iko Investigational Site

Caguas, , Puerto Rico

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Nichi-Iko Investigational Site

San Juan, , Puerto Rico

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Nichi-Iko Investigational Site

Kemerovo, , Russia

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Nichi-Iko Investigational Site

Moscow, , Russia

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Nichi-Iko Investigational Site

Moscow, , Russia

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Nichi-Iko Investigational Site

Novosibirsk, , Russia

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Nichi-Iko Investigational Site

Penza, , Russia

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Nichi-Iko Investigational Site

Petrozavodsk, , Russia

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Nichi-Iko Investigational Site

Ryazan, , Russia

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Nichi-Iko Investigational Site

Saint Petersburg, , Russia

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Nichi-Iko Investigational Site

Saint Petersburg, , Russia

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Nichi-Iko Investigational Site

Saint Petersburg, , Russia

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Nichi-Iko Investigational Site

Saint Petersburg, , Russia

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Nichi-Iko Investigational Site

Tomsk, , Russia

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Nichi-Iko Investigational Site

Vladimir, , Russia

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Nichi-Iko Investigational Site

Yaroslavl, , Russia

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Nichi-Iko Investigational Site

Yaroslavl, , Russia

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Nichi-Iko Investigational Site

A Coruña, , Spain

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Nichi-Iko Investigational Site

Barcelona, , Spain

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Nichi-Iko Investigational Site

Barcelona, , Spain

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Nichi-Iko Investigational Site

Santiago de Compostela, , Spain

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Nichi-Iko Investigational Site

Santiago de Compostela, , Spain

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Nichi-Iko Investigational Site

Seville, , Spain

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Nichi-Iko Investigational Site

Kharkiv, , Ukraine

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Nichi-Iko Investigational Site

Kharkiv, , Ukraine

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Nichi-Iko Investigational Site

Kharkiv, , Ukraine

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Nichi-Iko Investigational Site

Kyiv, , Ukraine

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Nichi-Iko Investigational Site

Kyiv, , Ukraine

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Nichi-Iko Investigational Site

Kyiv, , Ukraine

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Nichi-Iko Investigational Site

Lviv, , Ukraine

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Nichi-Iko Investigational Site

Odesa, , Ukraine

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Nichi-Iko Investigational Site

Ternopil, , Ukraine

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Nichi-Iko Investigational Site

Vinnytsia, , Ukraine

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Nichi-Iko Investigational Site

Vinnytsia, , Ukraine

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Nichi-Iko Investigational Site

Vinnytsia, , Ukraine

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Nichi-Iko Investigational Site

Zaporizhzhya, , Ukraine

Site Status

Nichi-Iko Investigational Site

Zhytomyr, , Ukraine

Site Status

Nichi-Iko Investigational Site

Bury St Edmunds, , United Kingdom

Site Status

Nichi-Iko Investigational Site

Gillingham, , United Kingdom

Site Status

Nichi-Iko Investigational Site

Leicester, , United Kingdom

Site Status

Nichi-Iko Investigational Site

Truro, , United Kingdom

Site Status

Countries

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United States Czechia Poland Puerto Rico Russia Spain Ukraine United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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NI071F2

Identifier Type: -

Identifier Source: org_study_id

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