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: 5 February 2018
• Main ID: EUCTR2014-000110-61-ES
• Date of registration: 01/06/2015
• 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: 06/07/2015
• Target sample size: 600
• 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:
_ Have completed all 24 weeks of study procedures (including dosing) according to protocol FKB32-002, with a minimum of 8 doses of study drug received, and are continuing with concomitant MTX and folate. _ In the investigator?s opinion, the patient showed a clinical response to treatment during Study FKB327-002.
_ Are willing to participate in the study and have provided written informed consent.
_ 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 510
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion criteria:
_ 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.
_ 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.
_ 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.
_ 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: 18.0 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
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-

Primary Outcome(s)

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 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)

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.

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

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 (DAS) 28 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)

FKB327-003

2014-000110-61-DE

Source(s) of Monetary Support

Fujifilm Kyowa Kirin Biologics Co., Ltd.