A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
ARABESC-OLE
An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate
1 other identifier
interventional
645
11 countries
92
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Typical duration for phase_3
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedStudy Start
First participant enrolled
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2018
CompletedResults Posted
Study results publicly available
March 26, 2019
CompletedMarch 26, 2019
March 1, 2019
2.6 years
March 17, 2015
January 18, 2019
March 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I
Period I: Patients were carefully monitor for Adverse Events from signing of informed consent until week 30 and thereafter during Period II of the study. For patients who discontinued early, a follow-up period of 4 weeks was added to the Early Termination Visit. The investigator actively asked the patients for Adverse Events. Patients spontaneously reported Adverse Events to the Investigator during clinic visits or in between visits.
Period I: from Week 0 up until Week 30;
Number of Patients With Adverse Events as a Measure of Safety in Period II - Single Treatment Period
From week 30 all subjects were transferred to receive FKB327 treatment. Adverse Events were contentiously monitored and recorded during Period II. For patients discontinuing the study prematurely, a follow-up period of 4 weeks was added to the Early Termination Visit. The data for Period II is based on the number of patients in the Safety Analysis Set that entered Period II.
Period II: from Week 30 up to Week 80
Number of Patients With Serious Adverse Events as a Measure of Safety Per Treatment Group in Period I
A Serious Adverse Event (SAE) was defined in the Protocol as: Death; or a Life-threatening Adverse Event (AE); Inpatient Hospitalization; Persistant or significant disability or incapacity; A congenital anomaly/birth defect; An important medical event that may not have resulted in death, have been life-threatening, or required hospitalization, but may have jeopardized the patient and may have required medical intervention to prevent 1 of the outcomes listed in this definition. SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
Period I: from Week 0 up until Week 30
Number of Patients With Serious Adverse Events as a Measure of Safety in Period II - Single Treatment Period
Period II: at week 30 all patients were transferred to receive FKB327. Each subject was counted once within each System Organ Class (SOC) and Preferred Term (PT). Death defined as a fatal outcome of a (S)AE. SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was lost to follow-up.
Period II: from Week 30 up to Week 80
Changes in Vital Signs as a Measure of Safety - Systolic Blood Pressure
Systolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Systolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Systolic Blood Pressure with changes from Baseline\_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit. Baseline\_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.
From Week 0 to Week 80
Changes in Vital Signs as a Measure of Safety - Diastolic Blood Pressure
Diastolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Diastolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Diastolic Blood Pressure with changes from Baseline\_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit measured. Baseline\_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.
From Week 0 to Week 80
Changes in Vital Signs as a Measure of Safety - Pulse Rate
Pulse rate is part of Vital Signs which were part of the subject safety evaluations. Pulse rate was measured at the following time-points: Weeks 0, 4, 8, 12, 24 and 80/End of Study (EOS). Pulse Rate with changes from Baseline\_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit. Baseline\_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002.
From Week 0 to Week 80
Changes in Vital Signs as a Measure of Safety - Temperature Measurements
Temperature measurements forms part of the vital signs which was one of the continuous safety measurements for the study primary endpoint. Temperature was measured at week 0, week 4, week 8, week 12, week 24 and at week 80 or at End of Study (EOS). Temperature with change from Baseline\_002 were summarized by treatment sequence over the whole study period. Baseline\_002 is defined as the last non-missing measurement collected prior to the first study medication administration at Week 0 from Study FKB327-002 (NCT02260791).
From Week 0 to Week 80
Summary of Most Common Clinical Significant Laboratory Parameters Reported as Adverse Events (Reported by ≥1% of the Patients)
Clinical Laboratory tests for hematology and serum chemistry were performed by the sites and analysed at a Central Laboratory. Urine dip-stick tests were performed by the sites. Laboratory samples were taken at the following time-points (weeks): 0; 4; 8; 12; 24; 30; 42; 54; 66; 76 and 80/End of Study (EOS). Each result outside its normal range was review and assessed by the investigator whether or not it was Clinically Significant (CS) or Not Clinically Significant (NCS) CS laboratory abnormalities were recorded as AEs.
From Week 0 to Week 80
Secondary Outcomes (4)
Changes in Disease Activity Score 28 Based on C Reactive Protein (DAS28 CRP) Score Compared to Baseline as a Measure of Efficacy
From Week 0 of FKB327-002 to Week 80
American College of Rheumatology 20 (ACR20) Response Rates From Baseline as a Measure of Efficacy
From Week 0 to Week 80
American College of Rheumatology 50 (ACR50) Response Rates From Baseline as a Measure of Efficacy
From Week 0 to Week 80
American College of Rheumatology 70 (ACR70) Response Rates From Baseline as a Measure of Efficacy
From Week 0 to Week 80
Other Outcomes (2)
Proportion of Patients Developing Anti-drug Antibodies (ADAs)
From Week 0 to Week 80
Trough Adalimumab Concentration
From Week 0 to Week 80
Study Arms (2)
FKB327
EXPERIMENTALPatients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
Humira®
ACTIVE COMPARATORPatients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791) and are continuing with methotrexate
- In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 (NCT02260791)
You may not qualify if:
- Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
- Patient has presence of active and/or untreated latent tuberculosis (TB)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
Research Site
Peoria, Arizona, 85381, United States
Research Site
Palm Desert, California, 92260, United States
Research Site
Boca Raton, Florida, 33486, United States
Research Site
Brandon, Florida, 33511, United States
Research Site
Jacksonville, Florida, 32207, United States
Research Site
Miami, Florida, 33135, United States
Research Site
Sarasota, Florida, 34239, United States
Research Site
Shreveport, Louisiana, 71101, United States
Research Site
Lansing, Michigan, 48910, United States
Research Site
Durham, North Carolina, 27704, United States
Research Site
Middleburg Heights, Ohio, 44130, United States
Research Site
Duncansville, Pennsylvania, 16635, United States
Research Site
Amarillo, Texas, 79124, United States
Research Site
Austin, Texas, 78745, United States
Research Site
Mesquite, Texas, 75150, United States
Research Site
Saint Catherines, Ontario, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Osorno, Chile
Research Site
Puerto Varas, Chile
Research Site G
Santiago, Chile
Research Site M
Santiago, Chile
Research Site
Temuco, Chile
Research Site
Brno, Czechia
Research Site
Hlučín, Czechia
Research Site U
Prague, Czechia
Research Site
Prague, Czechia
Research Site
Uherské Hradiště, Czechia
Research Site
Zlín, Czechia
Research Site
Aachen, Germany
Research Site
Berlin, Germany
Research Site
Hamburg, Germany
Research Site
Munich, Germany
Research Site
Ratingen, Germany
Research Site B
Arequipa, Peru
Research Site M
Arequipa, Peru
Research Site CA
Lima, Peru
Research Site CH
Lima, Peru
Research Site PA
Lima, Peru
Research Site S
Lima, Peru
Research Site D
Bialystok, Poland
Research Site R
Bialystok, Poland
Research Site
Gdynia, Poland
Research Site
Katowice, Poland
Research Site KL
Krakow, Poland
Research Site KR
Krakow, Poland
Research Site
Lublin, Poland
Research Site P
Poznan, Poland
Research Site RH
Poznan, Poland
Research Site
Torun, Poland
Research Site
Oradea, Bihor County, Romania
Research Site
Sfântu Gheorghe, Covasna, Romania
Research Site
Brasov, Romania
Research Site
Brăila, Romania
Research Site C
Bucharest, Romania
Research Site R
Bucharest, Romania
Research Site T
Bucharest, Romania
Research Site
Galati, Romania
Research Site
Ufa, Bashkortostan Republic, Russia
Research Site
Petrozavodsk, Karelia Republic, Russia
Research Site
Kazan', Tatarstan Republic, Russia
Research Site D
Moscow, Russia
Research Site SM
Moscow, Russia
Research Site ST
Moscow, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Penza, Russia
Research Site
Perm, Russia
Research Site
Ryazan, Russia
Research Site B
Saint Petersburg, Russia
Research Site Z
Saint Petersburg, Russia
Research Site
Saratov, Russia
Research Site
Smolensk, Russia
Research Site
Vladimir, Russia
Research Site E
Yaroslavl, Russia
Research Site S
Yaroslavl, Russia
Research Site
Santiago de Compostela, La Coruna, Spain
Research Site
Bilbao, Vizcaya, Spain
Research Site G
Barcelona, Spain
Research Site
Málaga, Spain
Research Site
Chernivtsi, Ukraine
Research Site
Ivano-Frankivsk, Ukraine
Research Site A
Kyiv, Ukraine
Research Site B
Kyiv, Ukraine
Research Site P
Kyiv, Ukraine
Research Site
Lutsk, Ukraine
Research Site C
Lviv, Ukraine
Research Site N
Lviv, Ukraine
Research Site
Poltava, Ukraine
Research Site
Ternopil, Ukraine
Research Site
Uzhhorod, Ukraine
Research Site G
Vinnytsia, Ukraine
Research Site Sh
Vinnytsia, Ukraine
Research Site St
Vinnytsia, Ukraine
Related Publications (2)
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.
PMID: 33263165DERIVEDGenovese 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.
PMID: 31831079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Information
- Organization
- Fujifilm Kyowa Kirin Biologics Co., Ltd., EU Branch
Study Officials
- PRINCIPAL INVESTIGATOR
Josephine Glover, MD
Coephycient Pharmaceutical Consultancy
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2015
First Posted
April 1, 2015
Study Start
June 10, 2015
Primary Completion
January 18, 2018
Study Completion
January 18, 2018
Last Updated
March 26, 2019
Results First Posted
March 26, 2019
Record last verified: 2019-03