Approval Probability
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Adjusted LOA
ML Risk
Non-Biologic DMARDs · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Tocilizumab Alone or in Combination with Methotrexate or DMARD | EXPERIMENTAL | Participants 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. |
| Name | Type | Description |
|---|---|---|
| Non-Biologic DMARDs | DRUG | Treatment 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. |
| Tocilizumab | DRUG | Tocilizumab 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. |
| Methotrexate | DRUG | Methotrexate will be administered per investigator's discretion. |
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...
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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.
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.
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.
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.
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.