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A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients

NCT ID: NCT02405780

Last Updated: 2019-03-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

645 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2018-01-18

Brief Summary

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The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.

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Detailed Description

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The first period of this extension study was an open label, randomised, comparative, multi centre, 2 arm extension Phase 3 study in patients with RA who were taking a stable dose of MTX and who had continued from the preceding Study FKB327-002 (NCT02260791). The transition from Study FKB327-002 was ideally to occur without interruption: the Week 24 visit of Study FKB327-002 was to be on the same day as the Week 0 visit of Study FKB327-003. Patients who had received FKB327 in Study FKB327-002 received FKB327 or Humira in a 2:1 ratio and patients who had received Humira in Study FKB327-002 received Humira or FKB327 in a 2:1 ratio (Period I). The second period of the study was an open label, single arm extension in which all patients received FKB327 treatment from Week 30 to Week 76 (Period II), followed by a 4 week Follow up period.

Clinic visits were scheduled for Weeks 0, 2, 4, 8, 12, 24, 30, 32, 34, 42, 54, 66, 76, and 80. The patient or carer was allowed to administer interim doses of study drug at home every other week (eow) between clinic visits.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FKB327

Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.

Group Type EXPERIMENTAL

FKB327

Intervention Type DRUG

Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.

Humira®

Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.

Group Type ACTIVE_COMPARATOR

Humira®

Intervention Type DRUG

Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.

Interventions

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FKB327

Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.

Intervention Type DRUG

Humira®

Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.

Intervention Type DRUG

Other Intervention Names

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adalimumab biosimilar adalimumab

Eligibility Criteria

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Inclusion Criteria

1. Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791) and are continuing with methotrexate
2. In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 (NCT02260791)

Exclusion Criteria

1. Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
2. Patient has presence of active and/or untreated latent tuberculosis (TB)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujifilm Kyowa Kirin Biologics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josephine Glover, MD

Role: PRINCIPAL_INVESTIGATOR

Coephycient Pharmaceutical Consultancy

Locations

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Research Site

Peoria, Arizona, United States

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Palm Desert, California, United States

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Boca Raton, Florida, United States

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Brandon, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Sarasota, Florida, United States

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Shreveport, Louisiana, United States

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Lansing, Michigan, United States

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Durham, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Duncansville, Pennsylvania, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Mesquite, Texas, United States

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Saint Catherines, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Osorno, , Chile

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Puerto Varas, , Chile

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Research Site G

Santiago, , Chile

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Research Site M

Santiago, , Chile

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Temuco, , Chile

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Brno, , Czechia

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Hlučín, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Uherské Hradiště, , Czechia

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Zlín, , Czechia

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Aachen, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Munich, , Germany

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Ratingen, , Germany

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Research Site B

Arequipa, , Peru

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Research Site M

Arequipa, , Peru

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Research Site CA

Lima, , Peru

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Research Site CH

Lima, , Peru

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Research Site PA

Lima, , Peru

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Research Site S

Lima, , Peru

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Research Site D

Bialystok, , Poland

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Bialystok, , Poland

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Gdynia, , Poland

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Katowice, , Poland

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Research Site KL

Krakow, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Torun, , Poland

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Oradea, Bihor County, Romania

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Sfântu Gheorghe, Covasna, Romania

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Brasov, , Romania

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Brăila, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Galati, , Romania

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Ufa, Bashkortostan Republic, Russia

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Petrozavodsk, Karelia Republic, Russia

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Kazan', Tatarstan Republic, Russia

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Moscow, , Russia

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Research Site SM

Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Penza, , Russia

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Perm, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Vladimir, , Russia

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Yaroslavl, , Russia

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Research Site S

Yaroslavl, , Russia

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Santiago de Compostela, La Coruna, Spain

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Bilbao, Vizcaya, Spain

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Research Site G

Barcelona, , Spain

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Málaga, , Spain

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Chernivtsi, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Research Site A

Kyiv, , Ukraine

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Research Site B

Kyiv, , Ukraine

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Research Site P

Kyiv, , Ukraine

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Lutsk, , Ukraine

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Lviv, , Ukraine

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Research Site N

Lviv, , Ukraine

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Poltava, , Ukraine

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Ternopil, , Ukraine

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Uzhhorod, , Ukraine

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Vinnytsia, , Ukraine

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Research Site Sh

Vinnytsia, , Ukraine

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Research Site St

Vinnytsia, , Ukraine

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Countries

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United States Canada Chile Czechia Germany Peru Poland Romania Russia Spain Ukraine

References

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Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

Reference Type DERIVED
PMID: 33263165 (View on PubMed)

Genovese MC, Glover J, Greenwald M, Porawska W, El Khouri EC, Dokoupilova E, Vargas JI, Stanislavchuk M, Kellner H, Baranova E, Matsunaga N, Alten R. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther. 2019 Dec 12;21(1):281. doi: 10.1186/s13075-019-2046-0.

Reference Type DERIVED
PMID: 31831079 (View on PubMed)

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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FKB327-003

Identifier Type: -

Identifier Source: org_study_id

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