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

Arthritis, Rheumatoid Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260791
• Other study ID #: FKB327-002
• Status: Completed
• Phase: Phase 3
• First received: July 29, 2014
• Last updated: October 23, 2017
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: Fujifilm Kyowa Kirin Biologics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 728
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• FKB327
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
• Humira®
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.

Locations

Country	Name	City	State
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	St. Catherines	Ontario
Canada	Research Site	Trois-Rivieres	Quebec
Chile	Research Site	Osorno
Chile	Research Site	Puerto Varas
Chile	Research Site G	Santiago
Chile	Research Site M	Santiago
Chile	Research Site	Temuco
Czechia	Research Site	Brno
Czechia	Research Site	Hlucin
Czechia	Research Site	Prague
Czechia	Research Site U	Prague
Czechia	Research Site	Uherske Hradiste
Czechia	Research Site	Zlin
Germany	Research Site	Aachen
Germany	Research Site	Berlin
Germany	Research Site	Hamburg
Germany	Research Site	Hildesheim
Germany	Research Site	Munich
Germany	Research Site	Ratingen
Peru	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 PE	Lima
Peru	Research Site S	Lima
Poland	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
Romania	Research Site	Braila
Romania	Research Site	Brasov
Romania	Research Site C	Bucharest
Romania	Research Site R	Bucharest
Romania	Research Site T	Bucharest
Romania	Research Site	Constanta
Romania	Research Site	Galati
Romania	Research Site	Oradea	Bihor
Romania	Research Site	Sfântu Gheorghe
Russian Federation	Research Site	Kazan	Tatarstan Republic
Russian Federation	Research Site D	Moscow
Russian Federation	Research Site SM	Moscow
Russian Federation	Research Site ST	Moscow
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Penza
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Petrozavodsk	Karelia Republic
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site B	Saint-Petersburg
Russian Federation	Research Site Z	Saint-Petersburg
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Smolensk
Russian Federation	Research Site	Ufa	Bashkortostan Republic
Russian Federation	Research Site	Vladimir
Russian Federation	Research Site E	Yaroslavl
Russian Federation	Research Site S	Yaroslavl
Spain	Research Site A	Barcelona
Spain	Research Site G	Barcelona
Spain	Research Site	Bilbao	Vizcaya
Spain	Research Site	Malaga
Spain	Research Site	Santiago de Compostela	La Coruna
Ukraine	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	Uzhgorod
Ukraine	Research Site G	Vinnytsia
Ukraine	Research Site Sh	Vinnytsia
Ukraine	Research Site St	Vinnytsia
United States	Research Site	Amarillo	Texas
United States	Research Site	Austin	Texas
United States	Research Site	Boca Raton	Florida
United States	Research Site	Brandon	Florida
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Durham	North Carolina
United States	Research Site	Jacksonville	Florida
United States	Research Site	Lansing	Michigan
United States	Research Site	Mesquite	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Miami Lakes	Florida
United States	Research Site	Middleburg Heights	Ohio
United States	Research Site	Palm Desert	California
United States	Research Site	Peoria	Arizona
United States	Research Site	Sarasota	Florida
United States	Research Site	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Kyowa Kirin Biologics Co., Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Chile,  Czechia,  Germany,  Peru,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Patients Developing Anti-drug Antibodies (ADAs)	Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.	Baseline and last sampling day
Other	Trough Adalimumab Concentration	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).	Week 2, Week 4, Week 12, Week 20, and Week 24
Primary	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])	Week 24
Secondary	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.	Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Secondary	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])	Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Secondary	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])	Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Secondary	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])	Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline, Week 12 and Week 24