Post marketing study to assess side effects, antibody development and effectiveness of Hetero-Rituximab
- Conditions
- Health Condition 1: C911- Chronic lymphocytic leukemia of B-cell typeHealth Condition 2: M317- Microscopic polyangiitisHealth Condition 3: C859- Non-Hodgkin lymphoma, unspecifiedHealth Condition 4: null- Non-Hodgkins lymphoma, Chronic Lymphocytic Leukemia,Rheumatoid Arthritis, Granulomatosis with polyangiitis(Wegener’s granulomatosis) and Microscopic polyangiitisHealth Condition 5: M069- Rheumatoid arthritis, unspecifiedHealth Condition 6: M313- Wegeners granulomatosis
- Registration Number
- CTRI/2018/03/012588
- Lead Sponsor
- Hetero Drugs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
2. Male and female adult patients, 18 years or older.
3. Patients with the following indications
o Patients with diagnosed Non-Hodgkin’s lymphoma
o Patients with diagnosed Chronic Lymphocytic Leukemia (CLL)
o Patients with diagnosed Rheumatoid arthritis
4. Any other patients indicated Rituximab as per physician’s discretion according to the prescribing information.
5. Adequate liver, renal, cardiac and haematological function as evidenced by:
o Transaminase (alanine transaminase [ALT]/aspartate transaminase [AST]) less than 2x upper limit of normal, or less than 5x upper limit of normal for patients with liver involvement
o Bilirubin <1.5 times ULN or total bilirubin =1.5 mg/dl, or total bilirubin =3 mg/dl for patients with Gilbert’s syndrome
o Absolute Neutrophil count =1500/mm
o Platelet count =100,000/mm
o Serum Creatinine less than 1.5x upper limit of normal
o Left ventricular ejection fraction (LVEF) =50%
1. Patients with clinical history/ evidence of allergy/hypersensitivity to murine proteins or components of Hetero-Rituximab.
2. An active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
3. Major surgery within 4 weeks of study start
4. Need for emergency therapy such as neurologic compression syndrome
5. Receipt of live vaccine within 4 weeks prior to study drug administration
6. Current medical history/clinical evidence of hepatitis B or hepatitis C infection or HIV
7. Patients who are likely to be pregnant or lactating patients
8. Patients with history or pre-existing clinical evidence of medically significant abnormality or requirements for surgery that precludes the usage of Hetero-Rituximab, as per
investigator’s discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence, severity, outcome, duration, action taken, and causality of individual adverse events [Expected and Unexpected adverse events (Serious and Non-serious Adverse Events)] reported during the studyTimepoint: All visits
- Secondary Outcome Measures
Name Time Method Efficacy- Change in efficacyTimepoint: at end of 6-8 cycles;Immunogenicity - development and change in antidrug antibodies (ADA) titer against Hetero – RituximabTimepoint: Screening, 6-8 cycles and 12 months