Health Condition 1: null- Adult patients with active moderately to severe Rheumatoid arthritis Health Condition 2: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: Adalimumab (Hetero Drugs Limited): - 0.4mL pre-filled single use syringe contains 20mg of Adalimumab
- 0.8mL pre-filled single-use syringe contains 40mg of Adalimumab
Control Interventi
Sponsors
Hetero Drugs Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Ability to comply with study and follow-up procedures and provide written informed consent • Diagnosis of Active Rheumatoid Arthritis as per the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for RA score of =6 and has a disease duration of at least three months before baseline • Swollen Joint Count (SJC) =6 (66 joint count), and Tender Joint Count (TJC) =6 (68 joint count) at screening and baseline • Erythrocyte sedimentation rate of more than 28mm/hr measured by westergreen method and C-reactive protein more than 6mg/L • Subjects must have been on treatment with methotrexate (10 to 25 mg/week) (oral or injectable) for at least 3 months and stable dose between 10 and 25 mg/week for at least 4 weeks prior to screening. Subjects who are on oral treatment will continue to have oral dose and those who are on injectable treatment will continue to have injectable dose. • Subjects using oral corticosteroids must have been on a stable dose of up to 10 mg/day prednisolone or equivalent, for at least 4 weeks prior to screening. If currently not using corticosteroids, the subjects must have not received corticosteroids for at least 4 weeks prior to screening. Prior escalation of doses of steroids will not be allowed. • If subjects using NSAIDs, they should have been on a stable dose for at least 4 weeks prior to screening • The screening laboratory tests must be: o Haemoglobin =8.0 g/dL o Neutrophils =1.5 × 109/L o Platelets =100 × 109/L o SGOT and SGPT =2 × ULN o Alkaline phosphatase levels =2 × ULN o Serum creatinine =1.7 mg/dL • Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection.
Exclusion criteria
Exclusion criteria: • Drug allergy, hypersensitivity or intolerance: Known or suspected allergy or hypersensitivity to Adalimumab or excipients • Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA • History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate within 4 weeks prior to randomization (8 weeks prior for leflunomide) • Prior use of any anti-CD4 therapy or TNFa antagonists (eg, infliximab, etanercept, certolizumab pegol or golimumab, tocilizumab, rituximab) including adalimumab. • Subjects with prior and current use of anakinra (IL-1 receptor antagonist) or abatacept. • Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit. Inhaled corticosteroids for stable medical conditions are allowed. • Subjects with autoimmune disease other than Rheumatoid Arthritis (psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC) and psoriasis (all types). • Active systemic bacterial, viral, fungal, mycobacterial, or other infections • Subject with known history or family history of active tuberculosis and/ or tests positive in QuantiFERON®-TB Gold In-Tube (QFT-G) • History of treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to screening • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease • History or presence of any form of cancer within the 10 years prior to screening except skin cancer and cervical cancer in-situ • Patients with uncontrolled diabetes or hypertension. • History of congestive heart failure (New York Heart Association class III/IV) or unstable angina • Current, recent (within 4 weeks prior to screening) or planned participation in an investigational drug study • History of alcohol or drug abuse within 6 months prior to screening • Pregnancy or lactation and positive pregnancy test (above clinical significant limits) in non-menopausal women • Patients with history or evidence of HIV infection, chronic hepatitis B, or hepatitis C infection • Blood donation or blood loss of >300ml in the last 3 months • Any medical, psychological, or social condition that may interfere with the subjects participation in the study or evaluation of the study results • Any psychological, familial or geographic situation that interferes in the adequate follow-up and adherence to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Proportion of patients with ACR 20 response (=20% improvement in the ACR core criteria) at end of 12 weeks study treatmentsTimepoint: 0, 2, 4, 6, 8 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change from baseline in Health Assessment Questionnaire (HAQ-DI) at the end of study treatmentsTimepoint: 0, 2, 4, 6, 8, 12, 16, 20 and 24 weeks;• Compare incidence and titres of anti-adalimumab antibodies between treatment groupsTimepoint: -3, 12 and 24 weeks;• Compare the single dose pharmacokinetic parameters of Cmax, AUC0-t, AUC0-inf, Kelt1/2, Tmax, CL, and VdTimepoint: Single dose at 0 week;• Proportion of patients with an ACR 50 and ACR 70 response (=50%, =70% improvement in the ACR core criteria) at the end of study treatmentsTimepoint: 0, 2, 4, 6, 8, 12, 16, 20 and 24 weeks;• Safety will be measured by adverse events, by monitoring of significant clinical signs and symptoms, and laboratory abnormalities during treatmentTimepoint: All visits;• Change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS 28-CRP) at the end of study treatmentsTimepoint: 0, 2, 4, 6, 8, 12, 16, 20 and 24 weeks;• Change from baseline in IL-6 and TNF-alpha levels at the end of study treatmentsTimepoint: -3 and 12 weeks;• Proportion of patients with ACR 20 response (=20% improvement in the ACR core criteria at 24 weeks (maximum study treatment duration)Timepoint: 16, 20 and 24 weeks | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha MD
Hetero Drugs Limited
Outcome results
None listed