Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

• Register: EUCTR
• Last refreshed on: 19 February 2018
• Main ID: EUCTR2014-000110-61-CZ
• Date of registration: 04/05/2015
• Prospective Registration: Yes
• Primary sponsor: Fujifilm Kyowa Kirin Biologics Co., Ltd.
• Public title: Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.
• Scientific title: 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 - ARABESC-OLE
• Date of first enrolment: 11/05/2015
• Target sample size: 680
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000110-61
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Canada, Chile, Czech Republic, Germany, Peru, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Fujifilm Kyowa Kirin Biologics Co., Ltd., EU Branch

• Name: Clinical Trial Information
• Affiliation: Fujifilm Kyowa Kirin Biologics Co., Ltd., EU Branch

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have completed all 24 weeks of study procedures (including dosing) according to protocol FKB32-002, with a minimum of 9 doses of study drug received, and are continuing with stable concomitant MTX and folate.
2. In the investigator’s opinion, the patient showed a clinical response to treatment during Study FKB327 002.
3. Are willing to participate in the study and have provided written informed consent.
4. Females of childbearing potential must have a negative pregnancy test prior to study dosing.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 580
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion criteria:
1. Evidence of a serious adverse event (SAE) ongoing from Study
FKB327-002 at entry to this study, including a serious infection,
malignancy, or any other condition that may put patients at increased risk when receiving treatment with adalimumab.
2. Presence of active and/or untreated latent tuberculosis (TB) as detected by QuantiFERON test at Week 22 combined with chest X-ray at Week 24 in Study FKB327-002. Latent TB, treated with prophylactic anti-mycobacterial therapy for at least 3 weeks before study dosing is resumed, is acceptable. Patients may have up to a maximum of 4 weeks interruption of dosing between the last dose in Study FKB327-002 and Week 0 dosing in study FKB327-003 for this purpose.
3. Were non compliant with FKB327-002 study procedures, or with any condition or circumstances, which, in the opinion of the Investigator, makes them unlikely or unable to comply with study procedures and requirements.
4. American College of Rheumatology (ACR) Functional Class IV.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Code: FKB327 PFS
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: FKB327
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Product Code: FKB327 AI
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: FKB327
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: _ To compare the efficacy of long-term treatment with FKB327 and
Humira in patients with RA.
_ To compare the proportion of patients developing anti-drug antibodies
(ADAs) on long-term treatment with FKB327 and Humira in patients with
RA.
_ To compare the pharmacokinetics (PK) of long-term treatment with
FKB327 and Humira in patients with RA.
_ To evaluate safety, changes in efficacy, and changes in PK and
immunogenicity in patients who are switched from Humira in the
preceding FKB327-002 double-blind study to FKB327 in the FKB327-003
open-label extension (OLE) study, and of patients who are switched from
FKB327 to Humira, respectively.
_ To evaluate safety, changes in efficacy, and changes in PK and
immunogenicity in patients who are switched from FKB327 in the
preceding FKB327-002 double-blind study to Humira in the FKB327-003
OLE study, and then switch back to FKB327 in the second part of the
FKB327-003 OLE study (from Week 30; double switch).

Timepoint(s) of evaluation of this end point: During entire duration of the study

Main Objective: The primary objective of this study is to compare the safety of long-term
treatment with FKB327 and Humira in patients with RA.

Primary end point(s): The primary endpoint of the study is safety. Safety will be evaluated
using the following assessments:
_ Adverse events (AEs).
_ SAEs, including serious infections and malignancies.
_ Vital signs.
_ Clinical laboratory tests.

Secondary Outcome(s)

Secondary end point(s): The secondary efficacy endpoints are as follows:
_ ACR20, ACR50 and ACR70 response rates from baseline (Week 0 from Study FKB327-002).
_ Changes in Disease Activity Score 28 based on C-reactive protein (CRP) (DAS28-CRP) score compared to baseline (Week 0 from Study FKB327-002).

Timepoint(s) of evaluation of this end point: They will be evaluated over time

Secondary ID(s)

2014-000110-61-DE

FKB327-003

Source(s) of Monetary Support

Fujifilm Kyowa Kirin Biologics Co., Ltd.