Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
High Dose Colchicine · 1 trial · 1 indication
Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.
| Arm | Type | Description |
|---|---|---|
| High Dose Colchicine | EXPERIMENTAL | After confirmation of a gout flare, patients were to begin standard dosing of colchicine 4.8mg (two capsules (1.8mg) initially followed by additional one capsule doses (0.6mg) every hour for an additional 6 doses). |
| Low Dose Colchicine | EXPERIMENTAL | Within 12 hours of a confirmed gout flare, patients were to begin the low dose colchicine regimen consisting of a total dose of 1.8 mg - two colchicine capsules initially (1.2 mg)followed an hour later by a single additional capsule of active drug(0.6 mg)then by 5 additional hourly doses of an identical looking placebo capsules |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| High Dose Colchicine (4.8 mg total dose) | DRUG | At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total of six additional doses (total colchicine dose 4.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center. |
| Low Dose Colchicine (1.8mg total dose) | DRUG | At randomization, patients were given an identical looking blister pack containing (3) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules and five placebo capsules. Patients were instructed to take 2 capsules initially (0.6 mg x 2) followed by an additional capsule every hour for a total of six additional doses (one active (0.6 mg) and 5 placebo capsules), a total colchicine dose = 1.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center |
| Placebo Control | OTHER | At randomization, patients were given an identical looking blister pack containing (8) placebo capsules identical in appearance to the study drug. Patients were instructed to take 2 capsules initially followed by an additional capsule every hour for a total of six additional doses beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center. |
Inclusion Criteria: 1. Patients of either gender and of any race ≥18 years of age. 2. If female, patients must be postmenopausal as evidenced by lack of menses for ≥12 consecutive months. 3. Patients must present with a confirmed diagnosis of gout. 4. Patients must have experienced ≥2 acute gouty a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Pegloticase, Methotrexate |
| Protalix BioTherapeutics, Inc. (DE) | PLX | 1 | PHASE2 | PRX-115, Methotrexate |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE1 | NNC4004-0002 |
| TJ Biopharma Co., Ltd. | IMAB | 1 | PHASE2 | Plonmarlimab, Compound betamethasone |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE1 | Pegylated Recombinant Candida Utilis Uricase |
High Dose Colchicine is used for the treatment of an acute gout flare. It is being developed as a small molecule therapy for gout, which is a metabolic condition characterized by sudden, severe attacks of pain, swelling, and redness in the joints.
High Dose Colchicine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the developer of this investigational therapy for gout.
High Dose Colchicine is in Phase 3 clinical development. It is an investigational drug and is not yet approved for use. The Phase 3 trial for High Dose Colchicine has been completed.
High Dose Colchicine has one completed Phase 3 clinical trial, identified as NCT00506883, titled 'MPC-004 for the Treatment of an Acute Gout Flare.' This randomized, double-blind, placebo-controlled trial enrolled 185 participants in the United States.
Yes, High Dose Colchicine is the same as MPC-004. The Phase 3 clinical trial for High Dose Colchicine is titled 'MPC-004 for the Treatment of an Acute Gout Flare,' indicating that MPC-004 is another name for this drug.