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A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients (ARABESC)

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FKB327
Humira®
Sponsored by
Fujifilm Kyowa Kirin Biologics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid, Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female aged 18 years or over
  2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
  3. Patient has active RA
  4. Patient has taken a stable dose of methotrexate for at least 3 months

Exclusion Criteria:

  1. Patient has been previously treated with adalimumab
  2. Patient has been previously treated or has ongoing treatment with prohibited medications
  3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks
  4. Patient has positive result for HIV, HBV, HCV or TB infection

Other Inclusion/Exclusion criteria may apply.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FKB327

Humira®

Arm Description

Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.

Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.

Outcomes

Primary Outcome Measures

American College of Rheumatology (ACR) 20 Response Rate
The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])

Secondary Outcome Measures

Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
ACR20 Response Rates Over Time
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])
ACR50 Response Rates Over Time
An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
ACR70 Response Rates Over Time
An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
Swollen Joint Count
Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.
Tender Joint Count
Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.
Analysis of Serum C-Reactive Protein (CRP) Concentration
Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.
Patient Assessment of Disease Activity
Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Physician Assessment of Disease Activity
Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Patient's Assessment of Pain
An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured ("No pain" at 0 and "Intolerable pain" at 100). Patient's assessment of pain is a value of the individual ACR core set variables.
Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.
DAS28-CRP Score Over Time
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.

Full Information

First Posted
July 29, 2014
Last Updated
October 23, 2017
Sponsor
Fujifilm Kyowa Kirin Biologics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02260791
Brief Title
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
Acronym
ARABESC
Official Title
A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujifilm Kyowa Kirin Biologics Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid, Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
728 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FKB327
Arm Type
Experimental
Arm Description
Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Arm Title
Humira®
Arm Type
Active Comparator
Arm Description
Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Intervention Type
Drug
Intervention Name(s)
FKB327
Intervention Description
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Intervention Type
Drug
Intervention Name(s)
Humira®
Intervention Description
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 20 Response Rate
Description
The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Description
The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
ACR20 Response Rates Over Time
Description
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
ACR50 Response Rates Over Time
Description
An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
ACR70 Response Rates Over Time
Description
An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Swollen Joint Count
Description
Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.
Time Frame
Baseline and Week 24
Title
Tender Joint Count
Description
Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.
Time Frame
Baseline and Week 24
Title
Analysis of Serum C-Reactive Protein (CRP) Concentration
Description
Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.
Time Frame
Baseline and Week 24
Title
Patient Assessment of Disease Activity
Description
Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Time Frame
Baseline and Week 24
Title
Physician Assessment of Disease Activity
Description
Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Time Frame
Baseline and Week 24
Title
Patient's Assessment of Pain
Description
An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured ("No pain" at 0 and "Intolerable pain" at 100). Patient's assessment of pain is a value of the individual ACR core set variables.
Time Frame
Baseline and Week 24
Title
Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.
Time Frame
Baseline and Week 24
Title
DAS28-CRP Score Over Time
Description
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Time Frame
Baseline and Week 24
Title
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
Description
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Time Frame
Baseline, Week 12 and Week 24
Other Pre-specified Outcome Measures:
Title
Percentage of Patients Developing Anti-drug Antibodies (ADAs)
Description
Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.
Time Frame
Baseline and last sampling day
Title
Trough Adalimumab Concentration
Description
Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).
Time Frame
Week 2, Week 4, Week 12, Week 20, and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 years or over Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months Patient has active RA Patient has taken a stable dose of methotrexate for at least 3 months Exclusion Criteria: Patient has been previously treated with adalimumab Patient has been previously treated or has ongoing treatment with prohibited medications Patient has been immunised with a live or attenuated vaccine in past 4 weeks Patient has positive result for HIV, HBV, HCV or TB infection Other Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josephine Glover, MD
Organizational Affiliation
Coephycient Pharmaceutical Consultancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Palm Desert
State/Province
California
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami Lakes
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Lansing
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Mesquite
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
St. Catherines
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Trois-Rivieres
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Osorno
Country
Chile
Facility Name
Research Site
City
Puerto Varas
Country
Chile
Facility Name
Research Site G
City
Santiago
Country
Chile
Facility Name
Research Site M
City
Santiago
Country
Chile
Facility Name
Research Site
City
Temuco
Country
Chile
Facility Name
Research Site
City
Brno
Country
Czechia
Facility Name
Research Site
City
Hlucin
Country
Czechia
Facility Name
Research Site U
City
Prague
Country
Czechia
Facility Name
Research Site
City
Prague
Country
Czechia
Facility Name
Research Site
City
Uherske Hradiste
Country
Czechia
Facility Name
Research Site
City
Zlin
Country
Czechia
Facility Name
Research Site
City
Aachen
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Hildesheim
Country
Germany
Facility Name
Research Site
City
Munich
Country
Germany
Facility Name
Research Site
City
Ratingen
Country
Germany
Facility Name
Research Site B
City
Arequipa
Country
Peru
Facility Name
Research Site M
City
Arequipa
Country
Peru
Facility Name
Research Site CA
City
Lima
Country
Peru
Facility Name
Research Site CH
City
Lima
Country
Peru
Facility Name
Research Site PA
City
Lima
Country
Peru
Facility Name
Research Site PE
City
Lima
Country
Peru
Facility Name
Research Site S
City
Lima
Country
Peru
Facility Name
Research Site D
City
Bialystok
Country
Poland
Facility Name
Research Site R
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site KL
City
Krakow
Country
Poland
Facility Name
Research Site KR
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site P
City
Poznan
Country
Poland
Facility Name
Research Site RH
City
Poznan
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Oradea
State/Province
Bihor
Country
Romania
Facility Name
Research Site
City
Braila
Country
Romania
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site C
City
Bucharest
Country
Romania
Facility Name
Research Site R
City
Bucharest
Country
Romania
Facility Name
Research Site T
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Constanta
Country
Romania
Facility Name
Research Site
City
Galati
Country
Romania
Facility Name
Research Site
City
Sfântu Gheorghe
Country
Romania
Facility Name
Research Site
City
Ufa
State/Province
Bashkortostan Republic
Country
Russian Federation
Facility Name
Research Site
City
Petrozavodsk
State/Province
Karelia Republic
Country
Russian Federation
Facility Name
Research Site
City
Kazan
State/Province
Tatarstan Republic
Country
Russian Federation
Facility Name
Research Site D
City
Moscow
Country
Russian Federation
Facility Name
Research Site SM
City
Moscow
Country
Russian Federation
Facility Name
Research Site ST
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Penza
Country
Russian Federation
Facility Name
Research Site
City
Perm
Country
Russian Federation
Facility Name
Research Site
City
Ryazan
Country
Russian Federation
Facility Name
Research Site B
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site Z
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saratov
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
Country
Russian Federation
Facility Name
Research Site
City
Vladimir
Country
Russian Federation
Facility Name
Research Site E
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site S
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Santiago de Compostela
State/Province
La Coruna
Country
Spain
Facility Name
Research Site
City
Bilbao
State/Province
Vizcaya
Country
Spain
Facility Name
Research Site A
City
Barcelona
Country
Spain
Facility Name
Research Site G
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Malaga
Country
Spain
Facility Name
Research Site
City
Chernivtsi
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research Site A
City
Kyiv
Country
Ukraine
Facility Name
Research Site B
City
Kyiv
Country
Ukraine
Facility Name
Research Site P
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lutsk
Country
Ukraine
Facility Name
Research Site C
City
Lviv
Country
Ukraine
Facility Name
Research Site N
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Poltava
Country
Ukraine
Facility Name
Research Site
City
Ternopil
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
Country
Ukraine
Facility Name
Research Site G
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site Sh
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site St
City
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
33263165
Citation
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.
Results Reference
derived
PubMed Identifier
31831079
Citation
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.
Results Reference
derived

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A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients

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