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Methylprednisone · 1 trial · 1 indication
The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.
| Arm | Type | Description |
|---|---|---|
| Rituximab + methotrexate (Group A) | EXPERIMENTAL | Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period. |
| Methotrexate (Group B) | ACTIVE_COMPARATOR | Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period. |
| Name | Type | Description |
|---|---|---|
| Rituximab | DRUG | Rituximab was supplied in single-use vials. |
| Methotrexate | DRUG | - |
| Methylprednisone | DRUG | Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. |
| C. albicans | BIOLOGICAL | Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm. |
| Tetanus toxoid adsorbed booster vaccine | BIOLOGICAL | Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle. |
| 23-valent pneumococcal polysaccharide vaccine | BIOLOGICAL | Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle. |
| Keyhole limpet hemocyanin | BIOLOGICAL | Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg) |
Inclusion Criteria: * Age 18-65 years. * Diagnosis of rheumatoid arthritis (RA) for at least 6 months. * Receiving treatment for RA on an outpatient basis. * Use of methotrexate (MTX) at a dose of 10-25 mg/wk (oral \[PO\] or subcutaneous \[SC\]) for at least 12 weeks prior to Day 1, with the dose s...
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Methylprednisone is an investigational small molecule being studied for the treatment of Rheumatoid Arthritis, an autoimmune condition affecting the joints. It is currently in Phase 2 clinical development, meaning it has not yet been approved and its safety and efficacy are still being evaluated in clinical trials.
The specific molecular target of Methylprednisone has not been disclosed in the available information. As a small molecule in Phase 2 development for Rheumatoid Arthritis, its mechanism of action is not publicly detailed, and no target class has been specified.
Methylprednisone is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded on the OTC market under the ticker symbol RHHBY.
Methylprednisone is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not received regulatory approval and is still being tested for safety and efficacy in patients with Rheumatoid Arthritis.
Methylprednisone has been studied in one completed clinical trial, identified as NCT00282308. This Phase 2 study evaluated the effects of rituximab on immune responses in subjects with active Rheumatoid Arthritis receiving background methotrexate, with a total enrollment of 103 participants in the United States.
No, Methylprednisone is not the same as Methylprednisolone. Methylprednisone is a distinct investigational drug being developed by Roche for Rheumatoid Arthritis, while Methylprednisolone is a different, established corticosteroid medication. They are separate compounds with different chemical structures and uses.