A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL\_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab. The primary objective of this study is to assess the immunogenicity of transitioning subjects with RA to DRL\_RI (biosimilar rituximab) from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab To assess the safety of transitioning subjects with RA to DRL\_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.

Key facts

Study ID

NCT04268771

Run by

Dr. Reddy's Laboratories Limited

People needed

140

Starts

2020-04-08

Expected to finish

2022-04-20

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged 18 years or older who have provided valid written informed consent.
• Subjects with a diagnosis of active RA who are eligible for the subsequent treatment course with US-rituximab or EU-rituximab according to the clinical judgment of the investigator.
• Documented evidence that subject has received at least 1 full course comprising two 1000 mg infusions of either US-rituximab at least 16 weeks prior to the randomization visit or EU-rituximab at least 24 weeks prior to the day of randomization visit.
• Subjects receiving a stable dose of weekly methotrexate (MTX) for at least 4 weeks prior to randomization (between 7.5 mg and 25 mg) and folic acid (at least 5 mg per week.
• EXCLUSION CRITERIA;
• Subjects with RA in functional Class IV
• Subjects with human immunodeficiency virus (positive HIV1Ab or HIV2Ab), hepatitis B virus and/or hepatitis C virus infection, including those with positive results in the viral disease screening.
• Subjects with active tuberculosis. Subjects with evidence of latent TB or a history of TB must have completed treatment or have initiated treatment for at least 1 month before the first dose of study treatment (Day 1). TB testing is required only if it is required by local regulations or practice.
• Active systemic infection.
• Severely immunocompromised.
• History of severe hypersensitivity to either US-rituximab or EU-rituximab or any of its excipients requiring drug discontinuation.
• Any serious illness or uncontrolled medical condition, including but not limited to severe infections, significant hepatic or renal disease, uncontrolled hypertension despite treatment (defined as blood pressure ≥160/95 mmHg), congestive heart failure (New York Heart Association [NYHA] Class III or IV), or other severe, uncontrolled cardiac disease or uncontrolled diabetes with immediate risk of acute complications.
• Any condition that in the opinion of the investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.
• Requires treatment with any biological medicinal product during the study other than the study treatment.
• Previous treatment with B-cell modulating or cell depleting biologic therapy except US-rituximab or EU-rituximab.
• Prior participation in this clinical trial or prior participation in any clinical trial with any monoclonal antibody within 12 months of screening or prior participation in any clinical trial within 3 months of screening or within 5 half-lives of the investigational drug or until the expected PD effect has returned to baseline, whichever is longer.
• Treatment with other biologic disease-modifying anti-rheumatic drugs, or Janus kinase (JAK) inhibitors administered within 12 weeks before the first dose of rituximab of the prior treatment course onwards till the date of randomization.
• Subjects with the following laboratory abnormalities:
• Subjects with screening total white blood cell count <3000/μL, platelets <100,000/μL, neutrophils <1,500/μL, or hemoglobin <8.5 g/dL
• Abnormal liver function tests such as aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >2 × upper limit of normal (ULN). A single parameter >2 × ULN can be re-checked as soon as possible, at least prior to randomization, if required as per the investigator's discretion.
• Creatinine clearance (Cockcroft \& Gault formula) of less than 50 mL/min.
• History of vaccination with live vaccines within 4 weeks of the first dose of study treatment (Day 1) or known to require live vaccines during the study.
• Lactating or pregnant female.
• Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g., barrier contraceptives, oral contraceptives, intrauterine devices, true abstinence if it allowed as per the country specific regulatory requirement [periodic abstinence {e.g., calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception], or sterilization) during treatment and for at least 12 months after the last administration of study treatment.
• For men involved in any sexual intercourse that could lead to pregnancy, subjects must agree to use 1 of the highly effective methods of birth control listed in Exclusion Criterion #16 during treatment and for at least 12 months after the last administration of study treatment.

Where it is running

• Arizona Arthritis and Rheumatology Research, PLLC — Phoenix, Arizona, United States
• California Allergy and Asthma Medical Group - CRN - PPDS 41230 11th Street West, Suite A — Palmdale, California, United States
• Inland Rheumatology Clinical Trials Incorporated — Upland, California, United States
• Rheumatology Consultant of Delaware dba Delaware Arthritis — Lewes, Delaware, United States
• MedBio Trials — Aventura, Florida, United States
• Clinical Research of West Florida Inc - Clearwater — Clearwater, Florida, United States
• Medical Research Center — Miami, Florida, United States
• AppleMed Research Group, LLC — Miami, Florida, United States
• Integral Rheumatology and Immunology Specialist, 140 Southwest 84th Avenue, Suite B — Plantation, Florida, United States
• Vicis Clinical Research INC — Tampa, Florida, United States
• Springfield Clinic (Clinic location) — Springfield, Illinois, United States
• Bluegrass Community Research Inc,330 Waller Avenue, Suite 100, — Lexington, Kentucky, United States
• Arthritis and Osteoporosis Associates — Freehold, New Jersey, United States
• Integrative Rheumatology — Charlotte, North Carolina, United States
• Altoona Center For Clinical Research, 175 Meadowbrook Lane, — Duncansville, Pennsylvania, United States
• Articularis Healthcare Group, Inc dba Low Country Rheumatology — Summerville, South Carolina, United States
• Accurate Clinical Management, LLC — Baytown, Texas, United States
• Trinity Clinical Research LLC, 2008 East Hebron Parkway, Suites 120/114/100, — Carrollton, Texas, United States
• Abigail Neiman — Houston, Texas, United States
• Accurate Clinical Management, LLC — Houston, Texas, United States
• Laila A Hassan, MD, PA — Houston, Texas, United States
• Accurate Clinical Research-Houston, 11003 Resource Parkway, Suite 102 — Houston, Texas, United States
• Houston Rheumatology & Arthritis Specialists — Katy, Texas, United States
• Clinical Associates in Research Therapeutics of America, LLC — San Antonio, Texas, United States
• Accurate Clinical Research, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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