Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tasocitinib plus Methotrexate · 1 trial · 1 indication
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
| Arm | Type | Description |
|---|---|---|
| Tofacitinib (CP 690,550) 10 mg BID plus MTX | EXPERIMENTAL | - |
| Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX | EXPERIMENTAL | - |
| Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tasocitinib plus Methotrexate | DRUG | Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months |
| Tofacitinib plus placebo methotrexate | DRUG | Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1. |
| Placebo tofacitinib plus Methotrexate | DRUG | Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib |
Inclusion Criteria: * Adult patients with moderate to severe early rheumatoid arthritis (\< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive. Exclusion Criteria: * Pregnant or lactating patients; * Patients with renal or hepatic impairment or other severe or p...
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Tasocitinib plus Ketoconazole is an investigational combination studied in healthy volunteers and in patients with rheumatoid arthritis. Tasocitinib, also known as CP-690,550, is a small molecule developed by Pfizer. The combination was evaluated in Phase 1 and Phase 2 clinical trials to assess drug absorption and potential interactions.
Tasocitinib plus Ketoconazole was studied for use in healthy volunteers to evaluate pharmacokinetic interactions and in patients with early rheumatoid arthritis to assess joint structure changes via MRI. The combination is investigational and not approved for any indication.
Tasocitinib plus Ketoconazole is developed by Pfizer, Inc., traded on the New York Stock Exchange under the ticker PFE. Pfizer conducted clinical trials of this combination in healthy subjects and in patients with rheumatoid arthritis.
Tasocitinib plus Ketoconazole has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials evaluated drug absorption and the effect of ketoconazole on tasocitinib pharmacokinetics in healthy volunteers. The Phase 2 trial assessed MRI-measured joint structure in early rheumatoid arthritis. It remains investigational.
Tasocitinib plus Ketoconazole has three completed trials: NCT01143805, a Phase 1 study of CP-690,550 tablet absorption in healthy subjects in Singapore; NCT01164579, a Phase 2 MRI study in early rheumatoid arthritis across multiple countries; and NCT01202240, a Phase 1 study of ketoconazole's effect on tasocitinib pharmacokinetics in healthy volunteers in Belgium.
Yes, Tasocitinib is also known as CP-690,550. Clinical trial records refer to the drug as CP-690,550, and the combination with ketoconazole is sometimes called Tasocitinib plus Ketoconazole. This naming appears in Pfizer's pharmacokinetic and efficacy studies.