Study to assess the 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: 8 August 2016
• Main ID: EUCTR2014-000109-11-ES
• Date of registration: 04/11/2014
• Prospective Registration: Yes
• Primary sponsor: Fujifilm Kyowa Kirin Biologics Co., Ltd.
• Public title: Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.
• Scientific 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.
• Date of first enrolment: 09/12/2014
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000109-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes 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:
_ Men or women aged ? 18 years.
_ RA, diagnosed to revised American College of Rheumatology (ACR) criteria (2010 version) at least 3 months prior to Screening.
_ Active RA, as confirmed by tender and swollen joint counts ?6 out of 68/66, respectively, at Screening and at Baseline.
_ C-reactive protein (CRP) level ?1.0 mg/dL at Screening.
_ Taking MTX (oral or parenteral) for at least 3 months prior to Screening and at a stable dose of between 10 and 25 mg/week for at least 8 weeks, with concomitant folic/folinic acid of at least 5 mg/week. Patients can start treatment with folic acid if not already receiving it.
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:
Patients will be excluded from the study if any of the following exclusion criteria are met (list not comprehensive):
_ Prior treatment with adalimumab.
_ Prior treatment with 2 or more biological disease modifying anti-rheumatic drugs (DMARDs) or protein kinase inhibitors for RA.
_ Prior treatment with tumour necrosis factor (TNF) inhibitors with lack of efficacy.
_ Prior treatment with cyclophosphamide or other cytotoxic agents.
_ Treatment with an investigational agent within 12 weeks or 5 half-lives of the drug.
_ Immunisation with a live or attenuated vaccine within 4 weeks prior to study drug dosing.
_ Intra-articular or parenteral steroids within 28 days prior to Screening.
_ Treatment with any DMARDs, other than MTX.
_ History of relevant allergy/hypersensitivity to monoclonal antibodies or any of the excipients of FKB327 or Humira.
_ Presence of autoimmune disease or joint disease other than RA.
_ ACR functional Class IV.
_ Major surgery within 8 weeks prior to Screening or planned to take place during the study period.
_ Presence of chronic or acute infection at Screening including positive result for human immunodeficiency virus (HIV) 1 or 2, hepatitis B (HBV), hepatitis C (HCV), and active tuberculosis (TB) or untreated latent TB.
_ Acute infection requiring parenteral antibiotics within 4 weeks of study dosing.
_ Presence of serious, uncontrolled disease of another body system including cardiovascular, neurological, pulmonary, renal and hepatic disease.
_ Presence of New York Heart Association (NYHA) Class III/IV heart failure.
_ Presence of any uncontrolled disease for which steroid treatment is regularly required for flares.
_ Presence of any malignancy or history of malignancy in the 5 years.
_ Patients with aspartate transaminase or alanine transaminase >1.5 × ULN, haemoglobin <8 g/dL, absolute neutrophil count<1500/?L, platelets <100,000/?L, and/or creatinine >1.5 × ULN.
_ Patients with demyelinating diseases.
_ Pregnant or breastfeeding women.
_ Patients with any condition or circumstances, which, in the opinion of the Investigator, make them unlikely or unable to comply with study procedures and requirements.
_ Body weight >120 kg.


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

Health Condition(s) or Problem(s) studied

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

Rheumatoid Arthritis
MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Code: FKB327
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: FKB327
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
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)

Secondary Objective: The secondary objectives of this study are as follows:
_ To compare the safety profiles of FKB327 and Humira, each in combination with methotrexate treatment.
_ To assess the efficacy profiles of FKB327 and Humira over time, including initial onset of effect.
_ To compare the proportions of patients on FKB327 and Humira, who develop anti drug antibodies (ADAs) and to summarise the distribution of the level of ADA activity between patients on FKB327 and Humira.
_ To compare the steady state pharmacokinetics of FKB327 and Humira administered by multiple dosing in patients with RA receiving concomitant treatment with methotrexate.

Main Objective: The primary objective of this study is to assess the efficacy of FKB327 compared with Humira®, when each is administered in combination with methotrexate.

Primary end point(s): The primary efficacy endpoint is the ACR20 response rate.

Timepoint(s) of evaluation of this end point: The ACR20 response rate is evaluated at Week 24.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: _ DAS28-CRP score is evaluated at Week 24.
_ ACR20, ACR50 and ACR70 response rates are evaluated over time.
_ Values of the individual ACR core set variables are evaluated over time.
_ DAS28-CRP score and change in DAS28-CRP score are evaluated over time.
_ DAS28-ESR score is evaluated at Weeks 12 and 24.

Secondary end point(s): The key secondary efficacy endpoint is as follows:
_ DAS28-CRP score.

Other secondary efficacy endpoints are as follows:
_ ACR20, ACR50 and ACR70 response rates.
_ Values of the individual ACR core set variables (swollen joint count, tender joint count, CRP, patient?s assessment of disease activity, physician?s assessment of disease activity, patient?s assessment of pain, Health Assessment Questionnaire Disability Index [HAQ DI]) .
_ DAS28-RP score and change in DAS28-CRP score .
_ DAS28 score based on erythrocyte sedimentation rate (DAS28-ESR).

Secondary ID(s)

FKB327-002

2014-000109-11-DE

Source(s) of Monetary Support

Fujifilm Kyowa Kirin Biologics Co., Ltd.