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DMARD

Phase 3

Rheumatoid Arthritis | Small molecule | Immunology |Roche Holding AG|Last Updated: Jan 26, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment401

FDA Designations

No designations recorded

Clinical trial landscape

DMARD · 1 trial · 1 indication

Phase 3 1
NCT01995201A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED401 Analytics
PHASE3COMPLETED
A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Sustained Clinical Remission, Disease Activity Scale 28 - Erythrocyte Sedimentation Rate <26 (DAS28-ESR <2.6) at Week 20 and Week 24
Week 20 and Week 24

The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.

Secondary Endpoints

Mean Change in Disease Activity Score 28 - Erythrocyte Sedimentation Rate(DAS28-ESR)
From week 24 up to week 48
Percentage of Patients Allocated in Groups A1 and A2 Who Remain With Clinical Remission Activity (DAS 28 ESR <2.6) up to Week 48
From week 28 up to week 48
Percentage of Patients Reporting Change in DAS 28 ESR >1.2 Until Week 48
From week 28 up to week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: All patientsEXPERIMENTAL -
Part 2 A: Sustained clinical remissionEXPERIMENTAL -
Part 2 B: Low disease activityEXPERIMENTAL -

Interventions

NameTypeDescription
DMARDDRUGnon-biological disease-modifying antirheumatic drugs at stable dose
methotrexateDRUGstable dose
tocilizumab [RoActemra/Actemra]DRUG162 mg subcutaneously (SC) qw, Weeks 1-24
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Active rheumatoid arthritis (DAS28-ESR \> 3.2), according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria of \> 6 months duration * Patients with intolerance or inadequate response to methotrexate or other non-biologic DMR...

Countries:IrelandPortugalSpain
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Frequently asked questions about DMARD

What is DMARD used for in rheumatoid arthritis?

DMARD is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied in patients with active rheumatoid arthritis, as part of a controlled clinical trial.

Who makes DMARD?

DMARD is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. Roche is conducting clinical research on this investigational therapy for rheumatoid arthritis. The drug is still in clinical development and has not been approved for commercial use.

What phase is DMARD in?

DMARD is in Phase 3 clinical development for rheumatoid arthritis. This phase typically involves larger studies to confirm efficacy and monitor safety. The drug is investigational and not yet approved. One Phase 3 trial has been completed, with 401 participants enrolled.

What clinical trials is DMARD in?

DMARD has one completed Phase 3 clinical trial, registered as NCT01995201. The study evaluated subcutaneous RoActemra/Actemra (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis. The trial enrolled 401 participants across Ireland, Portugal, and Spain.

Is DMARD the same as tocilizumab?

DMARD is a general term for disease-modifying antirheumatic drugs, and the clinical trial NCT01995201 specifically studied tocilizumab, also known as RoActemra/Actemra. The trial evaluated tocilizumab as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis.