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Chloroquine · 1 trial · 1 indication
DAS28-ESR score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), patient global assessment of disease activity (PGA) (general health \[GH\]) using visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in millimeters per hour \[mm/hr\]). The score is calculated using the following formula: DAS28-ESR = \[0.56 multiplied by (\*) square root (√) of TJC28\] plus (+) \[0.28\*√SJC28\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score of less than (\<) 2.6 represents DAS28-ESR remission.
| Arm | Type | Description |
|---|---|---|
| Tocilizumab | EXPERIMENTAL | Participants will receive tocilizumab 162 milligrams (mg) SC injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment is according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant may either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52. After Week 52, participants who remain in study will enter a 8 week wash-out period and then (from Week 60) will proceed to the extension phase until tocilizumab is commercially available in Greece. Permitted DMARDs include methotrexate, azathioprine, chloroquine, hydroxychloroquine, leflunomide, and sulfasalazine. |
| Name | Type | Description |
|---|---|---|
| Azathioprine | DRUG | Participants may receive azathioprine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline. |
| Chloroquine | DRUG | Participants may receive chloroquine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline. |
| Hydroxychloroquine | DRUG | Participants may receive hydroxychloroquine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline. |
| Leflunomide | DRUG | Participants may receive leflunomide as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline. |
| Methotrexate | DRUG | Participants may receive methotrexate as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline. |
| Sulfasalazine | DRUG | Participants may receive sulfasalazine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline. |
| Tocilizumab | DRUG | Participants will receive tocilizumab at a fixed dose of 162 mg SC QW either as monotherapy or in combination with non-biologic DMARDs. |
Inclusion Criteria: * Diagnosis of active rheumatoid arthritis according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria * Oral corticosteroids (less than or equal to \[\</=\] 10 milligrams per day \[mg/day\] prednisolone or equivalent) and non-steroidal anti-inflammatory drugs (NSA...
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Chloroquine is a small molecule being studied for the treatment of Rheumatoid Arthritis, an autoimmune condition affecting the joints. It is currently in Phase 3 clinical development for this indication, though it remains investigational and has not been approved for this use.
Chloroquine is being developed by Roche Holding AG, a pharmaceutical company traded on the OTC market under the ticker RHHBY. The company is conducting clinical research to evaluate the drug's potential in Rheumatoid Arthritis.
Chloroquine is in Phase 3 clinical development for Rheumatoid Arthritis. This stage typically involves larger studies to confirm efficacy and monitor safety, but the drug is still investigational and has not received regulatory approval for this condition.
Chloroquine is associated with one completed clinical trial, NCT01941095, which enrolled 100 participants with Rheumatoid Arthritis in Greece. The study was an open-label, uncontrolled trial that did not use randomization or blinding, and it has been completed.
Chloroquine is not FDA approved for Rheumatoid Arthritis. It is currently in Phase 3 clinical development, meaning it is still being evaluated in clinical trials and has not yet received regulatory approval for this indication.