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MabThera infusions

Phase 1

Rheumatoid Arthritis | Monoclonal antibody | Immunology |Teva Pharmaceutical Industries Limited|Last Updated: Oct 4, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

MabThera infusions · 1 trial · 1 indication

Phase 1 1
NCT01123070TL011 in Severe, Active Rheumatoid Arthritis PatientsRheumatoid Arthritis
COMPLETED54 Analytics
PHASE1COMPLETED
TL011 in Severe, Active Rheumatoid Arthritis Patients
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B
Day 1 to Day 57

Secondary Endpoints

Maximum Observed Concentration (Cmax) in Part B
Day 1 to Day 57
Number of Participants With Adverse Events in Part B
From randomization up to Week 24
Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B
Day 1, Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TL011EXPERIMENTALTL011 infusions
MabTheraACTIVE_COMPARATORMabThera infusions

Interventions

NameTypeDescription
TL011, anti CD20, for the treatment of rheumatoid arthritisBIOLOGICALTL011 administered by 2 infusions, 2 weeks apart
MabThera infusionsBIOLOGICALMabThera, administered by 2 infusions, 2 weeks apart
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Adult subjects * Rheumatoid arthritis as defined by the 1987 ACR Classification * Severe active seropositive disease * Inadequate response or intolerance to other DMARDs * Treatment with MTX Exclusion Criteria: * Rheumatic autoimmune disease other than RA * Active infection ...

Countries:CzechiaHungaryItalySpainUnited Kingdom
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Frequently asked questions about MabThera infusions

What is MabThera infusions used for in Rheumatoid Arthritis?

MabThera infusions is a monoclonal antibody being developed by Teva Pharmaceutical Industries Limited (TEVA) for the treatment of Rheumatoid Arthritis. It is currently in Phase 1 clinical development as an investigational therapy for this condition.

What does MabThera infusions target?

MabThera infusions is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential role in treating Rheumatoid Arthritis, an autoimmune condition.

Who makes MabThera infusions?

MabThera infusions is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company traded on the NYSE under the ticker TEVA. The company is conducting clinical research to evaluate the drug's safety and efficacy in Rheumatoid Arthritis.

What phase is MabThera infusions in?

MabThera infusions is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 54 participants with severe, active Rheumatoid Arthritis.

What clinical trials is MabThera infusions in?

MabThera infusions has one completed clinical trial registered as NCT01123070, titled 'TL011 in Severe, Active Rheumatoid Arthritis Patients'. This Phase 1 study enrolled 54 participants across Czechia, Hungary, Italy, Spain, and the United Kingdom, and was a randomized, double-blind, active-controlled trial.

Is MabThera infusions the same as TL011?

Yes, MabThera infusions is also known as TL011. The completed clinical trial NCT01123070 refers to the drug as TL011, indicating that these names are used interchangeably for the same investigational monoclonal antibody being studied in Rheumatoid Arthritis.