AI-Powered Research

Patients with active RA for at least one (1) year, diagnosed
according to the revised 1987 American College of
Rheumatology (ACR) criteria for the classification of
rheumatoid arthritis.
Receiving treatment on an outpatient basis.
RA functional class I, II, & III.
Active disease at the time of screening.
Swollen Joint Count (SJC) ≥ 8 (66 joint count), and Tender
Joint Count (TJC) ≥ 8 (68 joint count) at screening and
baseline.
At screening, either CRP ≥ 0.6 mg/dL or ESR ≥ 28 mm/h.
Must have had inadequate response to MTX and receiving and
tolerating a dose of 10-25 mg/wk (oral or parenteral) for at
least 12 weeks, with the last 4 weeks prior to baseline at a
stable dose.
Able and willing to give written informed consent and comply
with the requirements of the study protocol.
Patients must have been treated unsuccessfully with one or
more DMARDs.
Patients on the following DMARDs can be included in the
study with a washout period of:
4 weeks for Hydroxychloroquine
4 weeks for Chloroquine
4 weeks for Sulfasalazine
8 weeks for Leflunomide
8 weeks for Azathioprine
Glucocorticoids 10 mg/day of prednisolone or equivalent
permitted if stable for at least 4 weeks prior to baseline.
Use of NSAIDs is permitted if stable for at least 2 weeks prior
to baseline.
Patients of reproductive potential (males and females), and
willing to use a reliable means of contraception (e.g. hormonal
contraceptive patch, intrauterine device & physical barrier)
throughout study participation.

Exclusion Criteria

RA with significant secondary involvement of any systemic
organ (including but not limited to vasculitis, pulmonary
fibrosis or Felty's syndrome). Secondary Sjogren's syndrome
or limited cutaneous vasculitis is permitted.
RA with functional class IV
History of, or current, inflammatory joint disease other than
RA (e.g., gout, reactive arthritis, psoriatic arthritis,
seronegative spondyloarthropathy, Lyme disease) or other
systemic autoimmune disorder (e.g., systemic lupus
erythematosus, inflammatory bowel disease, scleroderma,
inflammatory myopathy, mixed connective tissue disease or
any overlap syndrome).
Diagnosis of juvenile idiopathic arthritis (JIA), also known as
juvenile rheumatoid arthritis (JRA) and/or RA before age 16.
Any surgical procedure, including bone/joint surgery/
synovectomy (including joint fusion or replacement) within 12
weeks prior to baseline or planned within 24 weeks of
randomization.
Lack of peripheral venous access.
Pregnancy or breast feeding.
Significant cardiac or pulmonary disease (including obstructive
pulmonary disease).
Evidence of significant uncontrolled concomitant disease
which in the investigator's opinion would preclude patient
participation.
Primary or secondary immunodeficiency (history of, or
currently active), including known history of human
immunodeficiency virus (HIV) infection.
Known active infection of any kind (excluding fungal
infections of nail beds), or any major episode of infection
requiring hospitalization or treatment with I.V. anti-infectives
within 4 weeks of baseline or completion of oral anti-infectives
within 2 weeks prior to baseline.
Chronic or current infectious disease such as, but not limited
to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis (at screening patients
with chest radiograph and history suggestive of tuberculosis
will be excluded)
History of infected joint prosthesis within five years.
History of cancer, including solid tumours, hematologic
malignancies and carcinoma in situ,
Any neurological (congenital or acquired), vascular or
systemic disorder which could affect any of the efficacy
assessments, in particular, joint pain and swelling (e.g.
Parkinson?s disease, cerebral palsy, diabetic neuropathy,
multiple sclerosis).
Currently active alcohol or drug abuse or history of alcohol or
drug abuse within 24 weeks prior to baseline.
History of a severe allergic or anaphylactic reaction to a
biologic agent or known hypersensitivity to any component of
T1h mAb or to murine proteins.
Previous treatment with any approved or investigational
biologic agent for RA during the past 1 year
Treatment with any investigational agent (non-biologic) within
28 days of baseline or 5 half-lives of the investigational drug
(which ever is the longer).
use of Cyclophosphamide and other cytotoxic agents
within 1 year before screening for this study.
Previous treatment with any cell depleting therapies, including
investigational agents.
Receipt of a live/attenuated vaccine within 28 days prior to
baseline (it is recommended that a patient's vaccination record
and the need for immunization prior to receiving T1h mAb
should be carefully investigated).
Intra-articular or parenteral glucocorticoids within 4 weeks
prior to baseline.
Intolerance or contraindications to i.v. glucocorticoids.
Positive tests for hepatitis B surface antigen (HBsAg) or
hepatitis C serology.
Hemoglobin < 8.0 g/dL.
Absolute Neutrophil count

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerabilityTimepoint: Defined under outcomes

Secondary Outcome Measures

Name	Time	Method
Secondary: ACR 20 response at six months. More than or equal to 50% and 70% improvement in the ACR response Changes in disease activity assessed using the DAS 28 core at 6 months Change in physical function assessed on change from aseline in the HAQ Disability Index at 6 months Change in the health-related quality of life assessed by the F-36 at 6 months Reduction in ESR and CRPTimepoint: Defined under outcomes