None listed
Conditions
Interventions
Intervention1: T1h mAb: 3 doses, total duration of participation in study is 24 weeks
Control Intervention1: Methotrexate: 10-25 mg/wk Total duration of participation in the study is 24 weeks
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerabilityTimepoint: Defined under outcomes | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactAbhijit Sharma
Outcome results
None listed