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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 730

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 =6 tender and =6 swollen joint counts out
of 68/66, respectively, at Screening and at Baseline.
_ C-reactive protein (CRP) level =10 mg/L 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 at Screening 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 622
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

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 more than 1 biologic or 1 protein kinase inhibitor
DMARD for RA.
_ Prior treatment with TNF inhibitors for RA with lack of efficacy.
_ Prior treatment with cyclophosphamide.
_ Treatment with an investigational agent within 12 weeks or 5 halflives
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, or history of clinically
significant contact allergy/hypersensitivity to latex or rubber.
_ Presence of active autoimmune disease or joint disease other than RA
(eg, mixed connective tissue disorder, gout) which may confound
efficacy assessments such as joint count evaluations or CRP/erythrocyte
sedimentation rate (ESR).
_ 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 or requiring oral/topical antibiotics within 2 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 demyelinating diseases.
_ Pregnant or breastfeeding women.
_ Patients with any condition or circumstances, which, in the opinion of
the Investigator, make them unsuitable for the study, unlikely or unable
to comply with study procedures and requirements.
_ Body weight >120 kg.
_ Prior or current treatment with an agent which might confound
efficacy or safety evaluation in this study, eg, RANKL inhibitors for
osteoporosis, immunomodulators for asthma within 5 half-lives of the
drug concerned prior to the first dose of study treatment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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