Approval Probability
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Anti-inflammatory drugs · 1 trial · 1 indication
An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.
| Arm | Type | Description |
|---|---|---|
| Rituximab 1000 mg (Stage I patients) | EXPERIMENTAL | Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations. |
| Rituximab 500 mg (Stage II patients) | EXPERIMENTAL | Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations. |
| Name | Type | Description |
|---|---|---|
| Rituximab | DRUG | Rituximab was supplied as a concentrate for IV administration at a concentration of 10 mg/mL in 500 mg (50 mL) single-use vials. |
| Anti-inflammatory drugs | DRUG | Each rituximab infusion was preceded by methylprednisolone 100 mg IV. Use of stable doses of oral corticosteroids was permitted (≤ 10 mg of prednisone or equivalent per day) as were stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs). |
Inclusion Criteria (Stage I): * Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active rheumatoid arthritis (RA) for ≥ 6 months * Receiving treatment for RA on an outpatient basis * Have had an inadequate response to at least one non-biological disease-mo...
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Anti-inflammatory drugs are used for the treatment of Rheumatoid Arthritis, an autoimmune condition characterized by joint inflammation and pain. This drug is being developed as a small molecule therapy for patients with active disease, as part of a combination regimen with other anti-rheumatic medications.
Anti-inflammatory drugs is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research to evaluate this small molecule therapy for the treatment of Rheumatoid Arthritis.
Anti-inflammatory drugs is in Phase 3 clinical development for Rheumatoid Arthritis. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform potential regulatory submissions.
Anti-inflammatory drugs has been studied in one Phase 3 clinical trial with the identifier NCT00443651. This completed trial, titled 'A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis,' enrolled 578 participants aged 18 years and older.
No, Anti-inflammatory drugs is not the same as Rituximab. The clinical trial NCT00443651 evaluated the safety of Rituximab in combination with other anti-rheumatic drugs, including Anti-inflammatory drugs. Anti-inflammatory drugs is a small molecule, whereas Rituximab is a biologic therapy.