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Non-Biologic DMARDs

Phase 3

Rheumatoid Arthritis | Small molecule | Immunology |Roche Holding AG|Last Updated: Jun 19, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Non-Biologic DMARDs · 1 trial · 1 indication

Phase 3 1
NCT01987479A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED150 Analytics
PHASE3COMPLETED
A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Adverse Events
Baseline up to Week 32

An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.

Secondary Endpoints

Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
Percentage of Participants Achieving an ACR50 Response
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tocilizumab Alone or in Combination with Methotrexate or DMARDEXPERIMENTALParticipants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.

Interventions

NameTypeDescription
Non-Biologic DMARDsDRUGTreatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study and is at the investigator's discretion.
TocilizumabDRUGTocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 24 weeks.
MethotrexateDRUGMethotrexate will be administered per investigator's discretion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria. * Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stabl...

Countries:Netherlands
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Frequently asked questions about Non-Biologic DMARDs

What is Non-Biologic DMARDs used for in Rheumatoid Arthritis?

Non-Biologic DMARDs are used for the treatment of Rheumatoid Arthritis. They are a class of small molecule drugs that modify the disease process rather than just treating symptoms. In this context, they are being studied in combination with tocilizumab to assess safety and efficacy in patients with this condition.

Who makes Non-Biologic DMARDs?

Non-Biologic DMARDs are developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on these agents in the context of Rheumatoid Arthritis treatment.

What phase is Non-Biologic DMARDs in?

Non-Biologic DMARDs are in Phase 3 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being evaluated in a completed Phase 3 study for Rheumatoid Arthritis.

What clinical trials is Non-Biologic DMARDs in?

Non-Biologic DMARDs have one completed Phase 3 trial, NCT01987479, which studied the safety and efficacy of tocilizumab alone or in combination with non-biologic antirheumatics in participants with Rheumatoid Arthritis. The trial enrolled 150 participants in the Netherlands.

Is Non-Biologic DMARDs the same as tocilizumab?

No, Non-Biologic DMARDs are not the same as tocilizumab. Tocilizumab is a biologic drug, while Non-Biologic DMARDs are a separate class of small molecule agents. In the clinical trial, they are studied together as a combination therapy for Rheumatoid Arthritis.