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

PHASE3CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

April 8, 2020

Primary Completion Date

January 26, 2022

Study Completion Date

April 20, 2022

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Experimental: Arm A: DRL_RI

Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion

BIOLOGICAL

Arm B: Rituxan®/Mabthera®

Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion

Trial Locations (26)

16635

Altoona Center For Clinical Research, 175 Meadowbrook Lane,, Duncansville

19958

Rheumatology Consultant of Delaware dba Delaware Arthritis, Lewes

28210

Integrative Rheumatology, Charlotte

29486

Articularis Healthcare Group, Inc dba Low Country Rheumatology, Summerville

33144

Medical Research Center, Miami

33155

AppleMed Research Group, LLC, Miami

33180

MedBio Trials, Aventura

33615

Vicis Clinical Research INC, Tampa

33765

Clinical Research of West Florida Inc - Clearwater, Clearwater

62702

Springfield Clinic (Clinic location), Springfield

75010

Trinity Clinical Research LLC, 2008 East Hebron Parkway, Suites 120/114/100,, Carrollton

77034

Accurate Clinical Research-League City, Texas City

77084

Abigail Neiman, Houston

Accurate Clinical Management, LLC, Houston

Laila A Hassan, MD, PA, Houston

77089

Accurate Clinical Research-Houston, 11003 Resource Parkway, Suite 102, Houston

77494

Houston Rheumatology & Arthritis Specialists, Katy

77521

Accurate Clinical Management, LLC, Baytown

78212

Clinical Associates in Research Therapeutics of America, LLC, San Antonio

78229

Accurate Clinical Research, Inc., San Antonio

85032

Arizona Arthritis and Rheumatology Research, PLLC, Phoenix

91786

Inland Rheumatology Clinical Trials Incorporated, Upland

93551

California Allergy and Asthma Medical Group - CRN - PPDS 41230 11th Street West, Suite A, Palmdale

33324.

Integral Rheumatology and Immunology Specialist, 140 Southwest 84th Avenue, Suite B, Plantation

40504.

Bluegrass Community Research Inc,330 Waller Avenue, Suite 100,, Lexington

07728

Arthritis and Osteoporosis Associates, Freehold

Sponsors
All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Dr. Reddy's Laboratories Limited

INDUSTRY

NCT04268771 - A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products | Biotech Hunter | Biotech Hunter