A study to determine pharmacodynamics (effect of drug in the body) and to compare pharmacokinetics (how drug behaves in the body), Safety and tolerability of single dose of Lupinâ??s Rituximab with Rocheâ??s Rituximab following I.V. infusion in Patients with Rheumatoid Arthritis
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2015/01/005398
- Lead Sponsor
- upin Limited Biotechnology Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
1.Ambulatory, patients of either sex aged 18 to 80 years (both inclusive) who are capable of understanding and giving written, voluntary informed consent.
2.Patients with definite RA defined according to â??The 2010 American College of Rheumatology (ACR) criteria for classification of RAâ??.
3.Patient with moderate to severe active RA disease as judged clinically.
4.Patients who are on Methotrexate (MTX) therapy for at least 12 weeks with last 4 weeks at stable dose, before screening.
5.Females who are non-child bearing potential (surgically sterile or menopausal) unless using birth control and non-pregnant & non-lactating. Women or men of reproductive potential who agree to use (or have his/her partner use) effective contraceptive methods starting from screening and for 12 months after the last Rituximab infusion (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partnerâ??s vasectomy or double-barrier method [condom or diaphragm with spermicide]).
1.Patients with known hypersensitivity to Rituximab or any other component of the product.
2.Patients suffering from acute or chronic, disseminated or localized (bacterial/fungal/viral) infections (except fungal nail bed infection) or sepsis or patients with a history of recurring infections or at increased risk of developing infections or sepsis.
3.Patients presently suffering from tuberculosis (including atypical tuberculosis).
4.Patients with other known rheumatic disease such as Sjogrenâ??s syndrome, systemic lupus erythematosus or spondyloarthritis or conditions that could predispose the patient to infection.
5.Patients who have known autoimmune diseases other than RA.
6.Significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Feltyâ??s syndrome) or ACR Global functional class IV disease.
7.Current malignancies or history of malignancy in past 3 years.
8.History of drug abuse or addiction of recreational drug or alcohol dependence or consumption of alcohol within 48 hours prior to dosing or unable to abstain from above during the study.
9.Patient who have received any live (attenuated) vaccines within 4 weeks of screening assessment.
10.Patients with seropositivity for HIV or HBV or HCV or any immunodeficiency &/or immunosuppressive disease.
11.Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation based on the Investigatorâ??s judgment. Conditions may include cardiovascular disease (including severe heart failure of New York Heart Association [NYHA] class IV or severe, uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, pulmonary, cardiovascular disease or history of any autoimmune disease or psychiatric disease as determined by medical history, physical examination, laboratory tests, chest X-ray, or ECG etc.
12.Impaired biochemical values at the screening assessment:
a.Patients with hemoglobin 8 mg/dl, platelet counts 125,000 per cubic mm or TLC 3500 per cubic mm
b.Impaired hepatic function: AST/ ALT/ Alkaline Phosphatase 3X ULN or Serum total bilirubin 2.0 mg/dl
c.Impaired renal function; serum creatinine 2X
d.Any significant pathology or past medical condition that can interfere with this protocol
13.Patients who have participated in any investigational study within the last 3 months prior to screening or are likely to simultaneously participate in another therapeutic clinical study.
14.Suspected or confirmed poor compliance, according to Investigatorâ??s judgment, in completing the trial and follow up (for mental, psychological or social reasons).
15.Patients who have taken other non-biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) (except MTX) within 4 weeks prior and leflunomide within 8 weeks to investigational product administration in this study.
16.Patients who have taken biologics within 12 months prior to investigational product administration in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic (AUC 0-t)of rituximab following IV infusions of rituximab (Lupin) and Rituximab (Roche)Timepoint: Up to day 15
- Secondary Outcome Measures
Name Time Method Pharmacodynamics parameter CD19 B cells countTimepoint: Up to day 15;Pharmacokinetic (Cmax, Vd, CL)Timepoint: Up to day 15