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MLTA3698A

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment211

FDA Designations

No designations recorded

Clinical trial landscape

MLTA3698A · 1 trial · 1 indication

Phase 2 1
NCT01225393A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED211 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis
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Study Endpoints

Primary Endpoints

Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR
Day 85
Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A
Length of study (through Day 85)

Secondary Endpoints

ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response )
Day 85
ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response )
Day 85
ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response)
Day 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
CPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MLTA3698ADRUGSubcutaneous repeating dose
adalimumabDRUGSubcutaneous repeating dose
leflunomideDRUGStable dose if not on methotrexate
methotrexateDRUGStable dose if not on leflunomide
placeboDRUGSubcutaneous repeating dose
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening * Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both * Active disease, defined as: CRP \>= 1.0 mg/dL; swoll...

Countries:United StatesBulgariaChileGermanyHungaryMexicoPeruPolandRomaniaSpain
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Frequently asked questions about MLTA3698A

What is MLTA3698A used for in rheumatoid arthritis?

MLTA3698A is an investigational small molecule being studied for the treatment of active rheumatoid arthritis. It is designed to be used in combination with a disease-modifying anti-rheumatic drug (DMARD) and was evaluated against adalimumab plus a DMARD in a Phase 2 clinical trial.

Who makes MLTA3698A?

MLTA3698A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this small molecule for the treatment of rheumatoid arthritis.

What phase is MLTA3698A in?

MLTA3698A is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is MLTA3698A in?

MLTA3698A has been studied in one completed Phase 2 trial, identified as NCT01225393. This randomized, double-blind, placebo-controlled study enrolled 211 participants with active rheumatoid arthritis and compared MLTA3698A plus a DMARD against adalimumab plus a DMARD.

Is MLTA3698A the same as adalimumab?

No, MLTA3698A is not the same as adalimumab. In the Phase 2 clinical trial NCT01225393, MLTA3698A in combination with a DMARD was compared with adalimumab in combination with a DMARD, indicating they are distinct treatments being evaluated against each other.